The Cochrane Library

Rapid diagnostic tests for diagnosing uncomplicated non-falciparum or Plasmodium vivax malaria in endemic countries

  • Review
  • Diagnostic

Authors

Abstract

Background

In settings where both Plasmodium vivax and Plasmodium falciparum infection cause malaria, rapid diagnostic tests (RDTs) need to distinguish which species is causing the patients' symptoms, as different treatments are required. Older RDTs incorporated two test lines to distinguish malaria due to P. falciparum, from malaria due to any other Plasmodium species (non-falciparum). These RDTs can be classified according to which antibodies they use: Type 2 RDTs use HRP-2 (for P. falciparum) and aldolase (all species); Type 3 RDTs use HRP-2 (for P. falciparum) and pLDH (all species); Type 4 use pLDH (fromP. falciparum) and pLDH (all species).

More recently, RDTs have been developed to distinguish P. vivax parasitaemia by utilizing a pLDH antibody specific to P. vivax.

Objectives

To assess the diagnostic accuracy of RDTs for detecting non-falciparum or P. vivax parasitaemia in people living in malaria-endemic areas who present to ambulatory healthcare facilities with symptoms suggestive of malaria, and to identify which types and brands of commercial test best detect non-falciparum and P. vivax malaria.

Search methods

We undertook a comprehensive search of the following databases up to 31 December 2013: Cochrane Infectious Diseases Group Specialized Register; MEDLINE; EMBASE; MEDION; Science Citation Index; Web of Knowledge; African Index Medicus; LILACS; and IndMED.

Selection criteria

Studies comparing RDTs with a reference standard (microscopy or polymerase chain reaction) in blood samples from a random or consecutive series of patients attending ambulatory health facilities with symptoms suggestive of malaria in non-falciparum endemic areas.

Data collection and analysis

For each study, two review authors independently extracted a standard set of data using a tailored data extraction form. We grouped comparisons by type of RDT (defined by the combinations of antibodies used), and combined in meta-analysis where appropriate. Average sensitivities and specificities are presented alongside 95% confidence intervals (95% CI).

Main results

We included 47 studies enrolling 22,862 participants. Patient characteristics, sampling methods and reference standard methods were poorly reported in most studies.

RDTs detecting 'non-falciparum' parasitaemia

Eleven studies evaluated Type 2 tests compared with microscopy, 25 evaluated Type 3 tests, and 11 evaluated Type 4 tests. In meta-analyses, average sensitivities and specificities were 78% (95% CI 73% to 82%) and 99% (95% CI 97% to 99%) for Type 2 tests, 78% (95% CI 69% to 84%) and 99% (95% CI 98% to 99%) for Type 3 tests, and 89% (95% CI 79% to 95%) and 98% (95% CI 97% to 99%) for Type 4 tests, respectively. Type 4 tests were more sensitive than both Type 2 (P = 0.01) and Type 3 tests (P = 0.03).

Five studies compared Type 3 tests with PCR; in meta-analysis, the average sensitivity and specificity were 81% (95% CI 72% to 88%) and 99% (95% CI 97% to 99%) respectively.

RDTs detecting P.vivax parasitaemia

Eight studies compared pLDH tests to microscopy; the average sensitivity and specificity were 95% (95% CI 86% to 99%) and 99% (95% CI 99% to 100%), respectively.

Authors' conclusions

RDTs designed to detect P. vivax specifically, whether alone or as part of a mixed infection, appear to be more accurate than older tests designed to distinguish P. falciparum malaria from non-falciparum malaria. Compared to microscopy, these tests fail to detect around 5% ofP. vivax cases. This Cochrane Review, in combination with other published information about in vitro test performance and stability in the field, can assist policy-makers to choose between the available RDTs.

Résumé scientifique

Tests de diagnostic rapide du paludisme non falciparum ou à Plasmodium vivax sans complication dans les pays endémiques

Contexte

Dans les contextes où le paludisme peut être dû aux infections à Plasmodium vivax ou à Plasmodium falciparum , les tests de diagnostic rapide (TDR) doivent distinguer l'espèce à l'origine des symptômes des patients, car des traitements différents sont requis. Les TDR plus anciens incorporent deux lignes de test pour distinguer le paludisme dû à P. falciparum du paludisme dû à toute autre espèce de Plasmodium (non falciparum). Ces TDR peuvent être classés selon les anticorps utilisés : les TDR de type 2 utilisent les anti-HRP-2 (pour P. falciparum) et les anti-aldolase (toutes espèces) ; les TDR de type 3 utilisent les anti-HRP-2 (pour P. falciparum) et les anti-pLDH (toutes espèces) ; les TDR de type 4 utilisent les anti-pLDH (pour P. falciparum) et les anti-pLDH (toutes espèces).

Plus récemment, des TDR ont été développés pour distinguer les parasitémies à P. vivax en utilisant un anticorps anti-pLDH spécifique à P. vivax.

Objectifs

Évaluer la précision diagnostique des TDR pour détecter les parasitémies non falciparum ou à P. vivax chez les personnes vivant dans des zones d'endémie palustre qui se présentent dans les établissements de santé ambulatoires atteints de symptômes évocateurs de paludisme ; et identifier les types et les marques de tests disponibles dans le commerce qui détectent le mieux le paludisme non falciparum et à P. vivax .

Stratégie de recherche documentaire

Nous avons entrepris une recherche exhaustive dans les bases de données suivantes jusqu'au 31 décembre 2013 : registre spécialisé du groupe Cochrane sur les maladies infectieuses ; MEDLINE ; EMBASE ; MEDION ; Science Citation Index ; Web of Knowledge ; Index Medicus Africain ; LILACS ; et IndMED.

Critères de sélection

Études comparant des TDR à un test de référence (microscopie ou amplification en chaîne par polymérase) pour l'examen d'échantillons de sang de patients randomisés ou assignés à des séries consécutives et se présentant dans un établissement de soins ambulatoires avec des symptômes pouvant être liés au paludisme dans des zones d'endémie non falciparum.

Recueil et analyse des données

Pour chaque étude, deux auteurs de la revue ont extrait indépendamment un ensemble standard de données en utilisant un formulaire d'extraction de données sur mesure. Nous avons regroupé les comparaisons par type de TDR (défini en fonction des combinaisons d'anticorps utilisées), et les avons combinées dans une méta-analyse le cas échéant. Les sensibilités et spécificités moyennes sont présentées avec des intervalles de confiance à 95 % (IC à 95 %).

Résultats principaux

Nous avons inclus 47 études portant sur 22 862 participants. Les caractéristiques des patients, les méthodes d'échantillonnage et les méthodes standard de référence étaient mal rapportées dans la plupart des études.

TDR détectant la parasitémie non falciparum

Onze études évaluent des tests de type 2 par rapport à la microscopie, 25 essais évaluent des tests de type 3, et 11 évaluent des tests de type 4. Dans les méta-analyses, les sensibilités et spécificités moyennes étaient respectivement de 78 % (IC à 95 % de 73 % à 82 %) et 99 % (IC à 95 % de 97 % à 99 %) pour les tests de type 2 ; de 78 % (IC à 95 % de 69 % à 84 %) et 99 % (IC à 95 % de 98 % à 99 %) pour les tests de type 3 ; et de 89 % (IC à 95 % de 79 % à 95 %) et 98 % (IC à 95 % de 97 % à 99 %) pour les tests de type 4. Les tests de type 4 étaient plus sensibles que les tests de type 2 (P = 0,01) et de type 3 (P = 0,03).

Cinq études comparent les tests de type 3 par rapport la PCR (amplification en chaîne par polymérase) ; dans la méta-analyse, la sensibilité et la spécificité moyenne étaient respectivement de 81 % (IC à 95 % de 72 % à 88 %) et 99 % (IC à 95 % de 97 % à 99 %).

TDR détectant la parasitémie à P.vivax

Huit études comparent des tests de pLDH par rapport à la microscopie ; la sensibilité et la spécificité moyenne étaient respectivement de 95 % (IC à 95 % de 86 % à 99 %) et 99 % (IC à 95 % de 99 % à 100 %).

Conclusions des auteurs

Les TDR conçus pour détecter spécifiquement le P. vivax , seul ou dans le cadre d'une infection mixte, semblent être plus précis que les tests plus anciens conçus pour distinguer le paludisme à P. falciparum du paludisme non falciparum. Par rapport à la microscopie, ces tests ne détectent pas environ 5 % des cas de P. vivax . Associée à d'autres informations publiées sur leurs performances dans les tests in vitro et leur stabilité sur le terrain, cette revue Cochrane peut aider les décideurs à choisir entre le tests de diagnostic disponibles.

Notes de traduction

Traduction réalisée par le Centre Cochrane Français

Plain language summary

Rapid tests for diagnosing malaria caused by Plasmodium vivax or other less common parasites

This review summarises trials evaluating the accuracy of rapid diagnostic tests (RDTs) for diagnosing malaria due to Plasmodium vivax or other non-falciparum species. After searching for relevant studies up to December 2013, we included 47 studies, enrolling 22,862 adults and children.

What are rapid tests and why do they need to be able to distinguish Plasmodium vivax malaria

RDTs are simple to use, point of care tests, suitable for use in rural settings by primary healthcare workers. RDTs work by using antibodies to detect malaria antigens in the patient's blood. A drop of blood is placed on the test strip where the antibodies and antigen combine to create a distinct line indicating a positive test.

Malaria can be caused any one of five species of Plasmodium parasite, but P. falciparum and P. vivax are the most common. In some areas, RDTs need to be able to distinguish which species is causing the malaria symptoms as different species may require different treatments. Unlike P. falciparum, P. vivax has a liver stage which can cause repeated illness every few months unless it is treated with primaquine. The most common types of RDTs for P. vivax use two test lines in combination; one line specific to P. falciparum, and one line which can detect any species of Plasmodium. If the P. falciparum line is negative and the 'any species' line is positive, the illness is presumed to be due to P. vivax (but could also be caused by P. malariae, or P. ovale). More recently, RDTs have been developed which specifically test for P. vivax.

What does the research say

RDTs testing for non-falciparum malaria were very specific (range 98% to 100%) meaning that only 1% to 2% of patients who test positive would actually not have the disease. However, they were less sensitive (range 78% to 89%), meaning between 11% and 22% of people with non-falciparum malaria would actually get a negative test result.

RDTs which specifically tested for P. vivax were more accurate with a specificity of 99% and a sensitivity of 95%, meaning that only 5% of people with P. vivax malaria would have a negative test result.

Résumé simplifié

Tests rapides pour diagnostiquer le paludisme dû à Plasmodium vivax ou à d'autres parasites moins courants

Cette revue résume les essais évaluant l'exactitude des tests de diagnostic rapide (TDR) pour diagnostiquer le paludisme dû à Plasmodium vivax ou à d'autres espèces non falciparum. Après avoir recherché les études pertinentes jusqu'à décembre 2013, nous avons inclus 47 études, portant sur un total de 22 862 adultes et enfants.

Que sont les tests rapides et pourquoi doivent-ils pouvoir distinguer le paludisme à Plasmodium vivax

Les TDR sont des tests simples utilisables directement au point de soins, adaptés pour une utilisation en milieu rural par le personnel des soins de santé primaires. Les TDR utilisent des anticorps pour détecter des antigènes du paludisme dans le sang du patient. Une goutte de sang est placée sur la bandelette de test, où les anticorps et les antigènes se combinent pour créer une ligne distincte indiquant un test positif.

Le paludisme (aussi appelé « malaria ») peut être dû à n'importe laquelle des cinq espèces du parasite Plasmodium mais P. falciparum et P. vivax sont les plus couramment rencontrés. Dans certaines régions, les TDR doivent être en mesure de distinguer l'espèce à l'origine des symptômes du paludisme, car des espèces différentes peuvent nécessiter des traitements différents. Contrairement à P. falciparum, P. vivax comporte un stade du parasite demeurant dans le foie qui peut occasionner des maladies répétées tous les quelques mois, sauf s'il est traité avec la primaquine. Les types les plus communs de TDR pour P. vivax utilisent une combinaison de deux lignes de test ; une ligne spécifique à P. falciparum et une ligne qui peut détecter toutes les espèces de Plasmodium. Si la ligne de P. falciparum est négative et la ligne « toutes espèces » est positive, la maladie est présumée être due à P. vivax (mais elle pourrait également être causée par P. malariae ou P. ovale). Plus récemment, des TDR ont été développés pour tester spécifiquement la parasitémie à P. vivax.

Que dit la recherche ?

Les TDR pour le paludisme non falciparum étaient très spécifiques (plage de 98 % à 100 %), ce qui signifie que seulement 1 % à 2 % des patients au test positif n'auraient en réalité pas la maladie. Toutefois, ils étaient moins sensibles (plage de 78 % à 89 %), ce qui signifie qu'entre 11 % et 22 % des personnes atteintes de paludisme non falciparum auraient en réalité un résultat de test négatif.

Les TDR testant spécifiquement la parasitémie à P. vivax étaient plus précis, avec une spécificité de 99 % et une sensibilité de 95 %, ce qui signifie que seulement 5 % des personnes atteintes de paludisme à P. vivax auraient un résultat de test négatif.

Notes de traduction

Traduction réalisée par le Centre Cochrane Français

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Background

 

Target condition being diagnosed

Malaria is a life-threatening illness caused by protozoan Plasmodium parasites, which are transmitted by many species of Anopheles mosquitoes. In 2008, there were between 190 and 311 million cases of malaria worldwide (WHO 2009b). The two most common species of parasites that cause malaria are Plasmodium falciparum andPlasmodium vivax. Falciparum malaria is the most common cause of severe malaria and malaria deaths and can also cause other complications, such as anaemia and, in pregnancy, low birthweight babies. Vivax malaria is a relapsing form, which is rarely fatal but can cause serious anaemia in children. Other, less common, Plasmodium species that cause malaria in people include P. malariae and P. ovale. Malaria is a curable disease, and therefore malaria-related morbidity and mortality can be reduced. Early, prompt and accurate diagnosis followed by appropriate treatment is the key to effective disease management (WHO 2003) and is a basic tenet of current malaria control policy (WHO 2005; Bell 2006).

People who are exposed repeatedly to Plasmodium infection develop a partial and incomplete immunity. This means that in highly endemic areas those most at risk are children under the age of five, who have not yet had the chance to develop immunity. In less endemic areas, or areas of seasonal or epidemic transmission, older children and adults are also at risk due to less developed immunity. Travellers from non-endemic to endemic countries are at highest risk because they have no immunity at all.

Index test(s)

Rapid diagnostic tests (RDTs) (WHO 2003) detect parasite-specific antigens in a drop of fresh blood through lateral flow immunochromatography (WHO 2006). The World Health Organization (WHO) currently lists 96 commercially available test kits meeting ISO131485 manufacturing standards (WHO 2009). RDTs do not require a laboratory or any special equipment (WHO 2006), are simple to use and can give results as a simple positive or negative result, at thresholds pre-set by the manufacturers, within 15 minutes (Talman 2007). Therefore, RDTs are, in general, suitable for remote areas with limited facilities and relatively untrained staff. However, they have a limited shelf life and need to be kept dry and away from temperature extremes. They may also fail to detect malaria where there are low levels of Plasmodium parasites in the blood, for example in young children with low immunity, and false positives are possible due to cross reactions or gametocytaemia (Kakkilaya 2003).

Different types of RDT use different types of antibody or combination of antibodies to detect Plasmodium antigens. Some antibodies aim to detect a particular species while others are pan-malarial, aiming to detect all types of Plasmodium. Table 1 lists the main types of RDT that were available in 2010. Since this classification was developed, the following test types have also become available:

Table 1. Types of malaria RDTs by antigen combination and parasite species detected
Type of test Antigen combinations Possible results
Type 1HRP-2 (P. falciparum specific)No Pf; Pf; invalid
Type 2HRP-2 (P. falciparum specific) and aldolase (pan-specific)No malaria; Pf or mixed; Pv, Pf, or Pm; invalid
Type 3HRP-2 (P. falciparum specific) and pLDH (pan-specific)No malaria; Pf or mixed; Pv, Pf, or Pm; invalid
Type 4pLDH (P. falciparum specific) and pLHD (pan-specific)No malaria; Pf or mixed; Pv, Pf, or Pm; invalid
Type 5pLDH (P. falciparum specific) and pLHD (P. vivax-specific)No malaria; Pf; Pv; Pf and Pv; invalid
Type 6HRP-2 (P. falciparum specific), pLHD (pan-specific) and pLDH (P. vivax specific)No malaria; Pf and Pv ± Po and/or Pm;  Pf ± Po and/or Pm;  Pv ± Po or Pm; Po or Pm; invalid
Type 7Aldolase (pan-specific)No malaria; Pf, Pv, Po,or Pm; invalid
OtherHRP-2 (P. falciparum specific) and pLDH (P. vivax specific)No malaria; Pf; Pv; Pf and Pv; invalid

  • Pan pLDH only, with possible results of: no malaria; P. falciparum (Pf), P. vivax (Pv), P. ovale (Po), or P. malariae (Pm); invalid

  • P. vivax specific pLDH only, with possible results of: no malaria; Pv; invalid;

  • P. falciparum specific HRP-2 and P. vivax specific pLDH, with possible results of: no malaria; Pf, Pv, Pf + Pv; invalid.

HRP-2 can stay in the blood for 28 days after initiating the antimalarial therapy (Kakkilaya 2003). Because of this 'persistent antigenaemia', it is not possible to use these tests in assessing parasite clearance following treatment, and false positive results may be found in patients who have recently been treated for malaria. In contrast, pLDH is rapidly cleared from the blood following parasite death; in fact it may clear more rapidly than the dead parasites (WHO 2009).

Alternative test(s)

Microscopic examination of Giemsa-stained thick and thin blood films remains the conventional laboratory method and is still regarded as the 'gold standard'. Microscopic examination provides a good sensitivity and specificity, and it allows species and stage differentiations and quantification of parasites, all of which are important in assessing the disease severity and prescribing appropriate therapy. Intensive examination is more likely to reveal parasitaemia so the test is carried out with a fixed number of fields examined. Infections may be missed if slides are not examined carefully (Wongsrichanalai 2007). Very low parasitaemia may be missed even by good quality microscopy; the limit of detection of thick smear microscopy has been estimated at approximately four to 20 asexual parasites per µL, although under field conditions a threshold of 50 to 100 asexual parasites per µL is more realistic (Wongsrichanalai 2007). False positive results are also possible; if blood slides are not prepared carefully, artefacts may be formed which can be mistaken for Plasmodium parasites (Wongsrichanalai 2007).

The polymerase chain reaction (PCR), which is a molecular method based on DNA amplification, is the most accurate method of detecting parasites in the blood. Compared to microscopy, PCR is less prone to observer error and more sensitive at low levels of parasitaemia (Snounou 1993). For PCR, the limit of detection may be as low as 0.004 asexual parasites per µL (Hänscheid 2002). However, whether this increased ability to detect low level parasitaemia makes it a better diagnostic test is uncertain, as sub-microscopic parasitaemia are of unknown clinical significance and the prevalence of asymptomatic sub-microscopic infection is high in some areas (May 1999). PCR is currently not widely available due to logistical constraints and the need for specially trained technicians and a well-equipped laboratory. It is usually used only for research purposes.

Rationale

A diagnostic test which is simple to perform, rapid and accurate is important in many situations to ensure prompt specific treatment, reduce misdiagnosis of non-malarial illness as malaria, limit the development of drug resistance (Talman 2007) and reduce drug wastage. The WHO lists some of the situations where RDTs can be particularly useful in remote areas without access to expert microscopy, complex emergencies and severe malaria, where rapid diagnosis is essential to save lives (WHO 2000).

The WHO 2010 guidelines recommend chloroquine for P. vivax malaria in areas in which parasites remain sensitive to this drug, although they are currently considering recommending artemisinin-based combination therapies (ACTs) for all P. vivax infections as they are effective (Gogtay 2013). Primaquine may be added to immediate treatment of P. vivax (and P. ovale) to effect a radical cure and prevent relapse (WHO 2010). Therefore, in areas where both P. falciparum and P. vivax are endemic, it is often useful to be able to distinguish between the two species.

The relative costs of microscopy and RDTs vary according to context. Where there is a relatively high prevalence of malaria and an established microscopy service, microscopy would usually be less expensive than RDTs because most of the costs associated with microscopy are fixed costs, and microscopy can also be used to diagnose other diseases. In areas where malaria is less prevalent, or very rural areas where access to good quality microscopy services is limited, RDTs may be less expensive than microscopy (WHO 2008). The cost of RDTs also depends on the type of test used, which will depend on the types of malaria parasite endemic in the area; the WHO describes three zones (WHO 2005a) as shown in Table 2.

Table 2. Malaria 'zones' by endemic parasite species and type of test appropriate for each
Zone Endemic malaria parasites Geographic area Appropriate test type
1 P. falciparum only or other species almost always as a mixed infectionMost of sub-Saharan Africa; lowland Papua New Guinea

Tests using HRP-2 to detect P. falciparum only

(Type 1)

2

Both P. falciparum and P. vivax, most commonly as a single species

 

Asia and the Americas; Ethiopian highlands

 

Combination RDTs which detect all species and distinguish between P. falciparum and P. vivax

(Types 2 to 6)

3

Non-falciparum only

 

Vivax-only areas of East Asia and Central Asia; some highland areas elsewhere

Pan-specific or vivax-specific RDTs

(Type 7; Pan-pLDH only; vivax-pLDH only)

RDTs may be used to confirm diagnosis before commencing treatment in people with symptoms of malaria where confirmation by microscopy is currently unavailable or unused, thereby increasing the specificity of diagnosis, which would otherwise be made on symptoms only. Alternatively, RDTs may replace microscopy for confirmatory diagnosis, where logistical factors and relative costs indicate that this may be beneficial. The usefulness of RDTs in these roles will depend to a large extent on their accuracy. The sensitivity and specificity thresholds that decide whether a test is useful in practice will depend upon the situation; as malaria endemicity varies enormously by geographic area, and positive and negative predictive values will vary considerably with endemicity, relating to the proportion of patients with fever who have malaria. In addition, microscopy is not a perfect reference standard in itself, and the relative accuracy of RDTs and microscopy will depend to a large extent on the performance of the laboratory facilities and personnel available for microscopy.

Previously published systematic reviews have focused on the accuracy of RDTs for diagnosing malaria in travellers returning to non-endemic countries from endemic countries (Marx 2005). As far as we know this is the first systematic review to assess the accuracy of the full range of RDTs for diagnosing non-falciparum orP. vivax malaria in people with symptoms in malaria-endemic areas.

This review is the second of two Cochrane Reviews assessing the accuracy of RDTs for diagnosing symptomatic uncomplicated malaria in endemic countries. It covers two slightly different target conditions; non-falciparum malaria in the absence of P. falciparum infection and P. vivax malaria, corresponding to the results obtainable with different RDT test types. The first review reported separately on RDTs for diagnosing P. falciparum malaria (Abba 2011). The summaries in this review are to assist decision making, in conjunction with other relevant information about these tests, including in vitro assessment and tests of stability and costs (WHO 2012).

Objectives

To assess the diagnostic accuracy of RDTs for detecting non-falciparum or P. vivax malaria parasitaemia in people living in malaria-endemic areas who present to ambulatory healthcare facilities with symptoms suggestive of malaria and to identify which types and brands of commercial test best detect non-falciparum and P. vivax malaria.

Investigation of sources of heterogeneity

We planned to investigate heterogeneity in relation to age group, continent where the study took place, and adequacy of reference standard.

Methods

Criteria for considering studies for this review

Types of studies

Studies sampling a consecutive series of patients, or a randomly selected series of patients were eligible. Where the report did not explicitly state that sampling was consecutive, but we judged that consecutive sampling was most probable, we included the report. We excluded studies if they did not present sufficient data to allow us to extract absolute numbers of true positives, false positives, false negatives and true negatives. Due to resource constraints, we also excluded studies if the report did not present enough information to allow full assessment of eligibility or if the study was reported only in a non-English language.

Participants

Studies recruiting people living in P. vivax,P. ovale or P. malariae endemic areas attending ambulatory healthcare settings with symptoms of uncomplicated malaria were eligible.

We excluded studies if participants:

  1. were non-immune people returning from endemic countries or were mainly recent migrant or displaced populations from non-endemic or very low endemicity areas;

  2. had been treated for malaria and the test was performed to assess treatment outcome;

  3. had symptoms of severe malaria;

  4. did not have symptoms of malaria;

  5. were recruited through active case finding (for example, door to door surveys).

In studies where only a subgroup of participants was eligible for inclusion in the review, we included the study provided that we could extract relevant data specific to that subgroup. If studies included some patients with severe malaria, and we could not extract data specific to a subgroup of participants with uncomplicated malaria, we included the study if 90% or more of the participants had uncomplicated malaria.

Index tests

Studies evaluating any immunochromatography-based RDTs specifically designed to detect non-falciparum or P. vivax malaria. We included commercial tests that are no longer available because they may use the same antibodies and very similar technology to tests that are currently available or may become available in the future. Older and more recently available versions of the same test, for example, OptiMAL and OptiMAL-IT were included separately. We also included prototype tests which are not longer available but which correspond to one of the commercial tests.

Comparator tests

We included studies regardless of whether they made comparisons with other RDT tests or not.

Target conditions

Studies aimed to detect non-falciparum or P. vivax malaria. Where no distinction was made by species, but over 98% of malaria infections were identified by the reference standard as non-falciparum or P. vivax, the study was eligible for inclusion.

Reference standards

Studies were required to diagnose non-falciparum or P. vivax malaria using at least one of the following two reference standards:

  1. Conventional microscopy of thick blood smears, thin blood smears or both. Presence of asexual parasites of any density was regarded as a positive smear;

  2. PCR.

The reference standard was required to be performed using blood samples drawn at the same time as those for the index tests. Where studies used more than one reference standard, we presented data relating to comparisons with each reference standard.

Search methods for identification of studies

We used a single search strategy for both Cochrane Reviews in this series (see Abba 2011).

Electronic searches

To identify all relevant studies, we used the search terms and strategy outlined in Appendix 1 to search the following databases: Cochrane Infectious Diseases Group Specialized Register; MEDLINE; EMBASE; MEDION; Science Citation Index; Web of Knowledge; African Index Medicus; LILACS; and IndMED. We based the search on the following MeSH, full text and keyword terms: Malaria, Plasmodium, reagent kits, diagnosis, diagnostics, RDT, dipstick, MRDD, OptiMal, Binax Now, Parasight, Immumochromatography, antigen detection, antigen test, Combo card. We did not limit the search by language or publication status (although we later excluded non-English language studies due to resource constraints). We restricted the searches to human studies. We updated the search on 31 December 2013.

Searching other resources

We searched the reference lists of included studies for relevant publications. Due to resource constraints, we did not search any other resources.

Data collection and analysis

Selection of studies

We initially used a single selection procedure to identify studies for inclusion in either of the two Cochrane Reviews in this series. The inclusion criteria differed between the reviews only in the target condition and parasite species. Therefore, of the study characteristics examined, we assessed parasite species last , for example a study listed as excluded due to not presenting sufficient data may also have not been a study of non-falciparum or P. vivax malaria. One author (KA) initially assessed the titles identified by the search, excluding those obviously irrelevant to the diagnosis of malaria using RDTs. We retained titles where we had any doubt regarding inclusion.

Based on abstract examination, we excluded irrelevant letters, review articles and articles and then excluded other irrelevant notes. Using a pro forma, two review authors (KA and NM) independently assessed the eligibility of the remaining potentially relevant articles based on full text publications. We have listed the excluded studies in the Characteristics of excluded studies table. We resolved any discrepancies by discussion. Where we could not reach agreement, we consulted a third author (PG or PO). Where it remained unclear whether a study was eligible for inclusion because of a lack of detail or poor reporting, we excluded it. Similiarly, we excluded non-English language reports for logistical reasons.

We named studies according to the surname of the first study author and the year of publication. The study naming used in this review uniquely identifies multiple study cohorts within each study report (for example as 'Bell 2001a' and 'Bell 2001b'), each of which use different reference standards or present data separately for more than one population with different characteristics. More than one RDT may be evaluated in each study cohort, thus the number of test evaluations exceeds the number of study cohorts, which exceeds the number of study reports.

Data extraction and management

Two review authors (KA and NM) independently extracted data and resolved any discrepancies by discussion. In cases of studies where only a subgroup of participants met the review inclusion criteria, we extracted and presented data only for that particular subgroup. Where two versions of one reference standard were used, for example local clinic and expert standard microscopy, or field versus laboratory RDT testing, we only included the one most likely to yield the highest quality results.

For each study, we systematically extracted data on the characteristics of the study, as shown in Appendix 2. We also extracted data relating to the sensitivity of the RDT at different levels of parasitaemia (asexual parasites per µL of blood) as presented by the study authors. For each comparison of index test with reference test, we extracted data on the number of true positives, true negatives, false positives and false negatives in the form of a two by two table. RDT results are dichotomous; microscopy results were deemed positive at any level of asexual parasitaemia; and PCR results used the cut-off points presented by the study authors. Gametocyte-only parasitaemia was considered negative; where a study was unclear on how they had classed gametocyte-only parasitaemia, they were assumed to have used the same classification as ourselves and we included the data in the study.

We extracted data for each study (Smidt 2008), using current manufacturers' instructions in interpreting the RDT results. P. falciparum malaria only was considered as negative for parasitaemia. The target condition was defined slightly differently depending on the type of the test, as follows:

  • Types 2, 3 and 4 - Non-falciparum malaria in the absence of falciparum malaria

RDT Types 2, 3 and 4 are designed to detect non-falciparum species (mainly P. vivax in most situations) when they occur without concurrent P. falciparum infection. They have two test lines, one specific for P. falciparum and one pan-malarial line to detect all malaria species. Non-falciparum malaria is identified by a positive pan-malarial line and negative P. falciparum line; mixed infections will produce positive results for both the P. falciparum and pan-malaria lines and are indistinguishable from P. falciparum alone.

Mixed infections detected by microscopy were considered true negative if RDT indicated P. falciparum; true positive if RDT indicated non-falciparum in the absence of P. falciparum; and false negative if RDT indicated no malaria. This method corresponded to the method most often described by the authors of the included studies, first described by Tjitra 1999.

  • Tests using Pf HRP2 and Pv pLDH - P. vivax (whether alone or part of mixed infection)

These types of tests are designed to identify P. vivax parasitaemia specifically, as they have a test line specific to P. vivax. Some also include other test lines, specific to other types of malaria parasite. Test results were considered positive for P. vivax whether or not they also indicated the presence of P. falciparum.

Where study authors interpreted test results or presented data differently, we used all the information presented in the paper to extract data consistent with our own methods; if we were unable to do this, we did not include the data in the analyses.

Assessment of methodological quality

Three researchers (KA, NM and SJ) assessed the quality of each individual study using the checklist adapted from the QUADAS tool (Whiting 2003). We answered each question on the checklist with a yes or no response, or noted unclear if study authors reported insufficient information to enable a judgement, and we documented the reasons for the judgement made. We have summarized the criteria we used in Appendix 3.

Statistical analysis and data synthesis

The comparisons made in this review can be considered in a hierarchy. We classified the data on each test type in the primary studies according to commercial brands. In order to provide a coherent description of the studies contributing to each analysis, we structured the results first by grouping studies according to their commercial brand, then grouping brands to form test types. The analytical strategy thus compared the test accuracy of commercial brands within each test type before making comparisons between test types. Comparative analyses first included all studies with relevant data, and were then restricted to studies that made direct comparisons between tests with the same participants, where such studies existed.

For each test type, we plotted estimates of the observed sensitivities and specificities in forest plots and in receiver-operating characteristic (ROC) space. These plots illustrate variation in accuracy between studies. Where adequate data were available, we performed meta-analyses using the bivariate model (Reitsma 2005) to produce summary sensitivities and specificities. Using a random-effects approach, the model jointly synthesises sensitivity and specificity by allowing for correlation between them across studies. We made comparisons between tests by adding a covariate for brand or test type to the bivariate model to investigate association with sensitivity or specificity, or both. Also, we investigated the effect of test type on the variances of the random effects of logit sensitivity and logit specificity and we included separate variance terms where required. We assessed the significance of the difference in test performance by a likelihood ratio test comparing models with and without covariate terms for sensitivity and specificity. Where inadequate studies were available to estimate all parameters, we simplified the bivariate model to two univariate random-effects logistic regression models by assuming no correlation between sensitivity and specificity. We fitted the models using the xtmelogit command in StataCorp 2011.

Where more than one commercial brand of the same test type was evaluated on the same patients against the same reference standard, we selected one brand at random from the analysis by test type in order to avoid bias due to inclusion of the same participants more than once in the analysis. We included both brands in any analyses comparing commercial brands.

Investigations of heterogeneity

We inspected forest plots and summary ROC plots to visually assess heterogeneity between study specific estimates of sensitivity and specificity. We planned to investigate the effect of age group, continent where the study took place, and adequacy of the reference standard on summary estimates of sensitivity and specificity by adding each factor as a covariate to the bivariate model.

We did not attempt to assess reporting bias because little is known about how this should be done for diagnostic test accuracy (DTA) reviews.

Results

Results of the search

In the initial search we identified 4837 titles, of which we excluded 4325 based on their title or abstract alone. We were unable to obtain one article in full text form. We retrieved full text articles for 511 titles; of which we excluded 474 articles; 316 because they were initially assessed as ineligible; 22 because the reports did not present enough information for us to assess their eligibility; 21 because they were available only in non-English languages; 21 because we were unable to extract absolute numbers of true positives, false positives, false negatives and true negatives; and 94 because they did not present data on non-falciparum or P. vivax malaria, although they were eligible for other reviews in this series. See Figure 1 for a flow diagram of search and eligibility results.

Figure 1.

Figure 1.

Study flow diagram.

We therefore included a total of 37 study publications. One of the included publications described two related studies, and another publication reported data separately for 10 different sites, making a total of 47 study cohorts. Seven of the 47 cohorts evaluated more than one test; one compared four tests, three compared three tests and three compared two tests. There were a total of 67 test evaluations reporting on a total of 32,466 tests in 22,862 participants. We have given a summary of the number of studies by test type and reference standard (microscopy or PCR) in Table 3.

Table 3. Number of studies by RDT type and reference standard
Type of RDT Number of study cohorts (test evaluations) by reference standard
Microscopy PCR
Non-falciparum species in the absence of P. falciparum
Type 211 (11)0 (0)
Type 323 (25)5 (5)
Type 410 (11)1 (1)
Other type1 (1)0 (0)
P. vivax
Pf HRP2 and Pv pLDH8 (9)2 (3)
Type 60 (0)1 (1)

Methodological quality of included studies

We summarised the overall methodological quality of the included studies in Figure 2. Twenty-seven study cohorts (57%) clearly included a representative spectrum of patients attending ambulatory healthcare setting with symptoms of malaria; the remaining 20 were unclear, most often because they had not adequately described their sampling methods. Twenty study cohorts (43%) reported an adequate reference standard, 19 (40%) did not provide enough information on the reference standard, and eight (17%) had an inadequate reference standard, in all cases because a second microscopist did not verify the results. Thirty-five study cohorts (75%) reported blinding of the reference standard results, 11 (23%) did not describe whether the reference standard was blinded and one (2%) did not blind the reference standard. Thirty-seven (79%) study cohorts blinded the RDT results to the results of the reference tests, nine (19%) were unclear and one (2%) did not blind the RDTs. All 47 cohorts reported avoidance of partial verification, differential verification and incorporation.

Figure 2.

Figure 2.

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Eleven study cohorts (23%) reported on uninterpretable test results; of these, three excluded uninterpretable results from the analysis, four reported that there were no uninterpretable results, three repeated any uninterpretable tests and one presented the results for uninterpretable tests. The proportion of uninterpretable tests was low in every study that reported this information (maximum 6%). Thirty study cohorts (64%) did not report on uninterpretable results, but appeared to have no uninterpretable results, because they had an exact correlation between the number of participants enrolled and the number presented in the analysis. Six study cohorts (13%) did not report on uninterpretable results and also either did not clearly state the number of participants initially enrolled or showed a discrepancy between the number of participants enrolled and the number presented in the analysis.

Thirty-seven study cohorts (79%) reported either no withdrawals from the study or recorded the reasons for any withdrawals; eight (17%) were unclear as to whether there were any withdrawals; one (2%) had one participant missing from the analysis, with no explanation, and another (2%) reported that samples with mixed infection or where microscopists disagreed were excluded, while the number of samples excluded, and the original number of participants enrolled, was not presented.

Findings

Target condition: non-falciparum malaria only

In this section we present the results for RDTs which identify 'non-falciparum malaria' by the presence of a positive pan-malaria antibody line in the absence of a positive P. falciparum specific antibody line.

Verified by microscopy
Type 2 tests

There were 11 evaluations of Type 2 RDTs verified with microscopy (Figure 3); eight were undertaken in Asia, two in Africa and one in South America. The median sample size was 372 (range 113 to 2383), the median prevalence of non-falciparum only malaria was 14% (range 7% to 32%) and the median percentage of malaria that was non-falciparum was 46% (range 13% to 80%). None of the evaluations were undertaken only in children under the age of five years. Five different test brands were evaluated: ICT Malaria Pf/Pv (seven); ICT Malaria combo cassette (one), Malascan (one), NOW Malaria ICT (one) and VIKIA Malaria Ag Pf/Pan (one). Sensitivities of the tests ranged from 67% to 90%; specificities ranged from 89% to 100%. In meta-analysis (11 evaluations, 6879 participants) the pooled sensitivity was 78% (95% confidence interval (CI) 73% to 82%) and the specificity was 99% (95% CI 97% to 99%) (Figure 4). Of the false negative RDT results (where microscopy identified non-falciparum malaria only, but RDT gave a different result) 65% (95% CI 43% to 81%) of RDT results indicated 'no malaria'; the remaining false negative RDT results indicated P. falciparum or mixed infection (Table 4).

Figure 3.

Figure 3.

Forest plot of commercial brands of Type 2 tests for detection of non-falciparum species (verified with microscopy). We ordered studies by continent, age group and study identifier.

Figure 4.

Figure 4.

Summary ROC plot of Type 2 tests for detection of non-falciparum species (verified with microscopy). The black solid circle corresponds to the summary estimate of sensitivity and specificity, and is shown with a 95% confidence region.

Table 4. False negatives for non-falciparum and P. vivax by RDT type

  1. *The pooled estimates of the percentage of false negatives indicating 'no malaria' and the percentage of false negatives indicating 'P. falciparum' were computed by using a random effects logistic regression model for Type 2 and Type 3. A fixed effects logistic regression model was used for Type 4.

    This table shows participants with non-falciparum malaria monoinfection identified by microscopy who were negative by non-falciparum monoinfection by RDT, by whether the RDT incorrectly identified the participant as not having malaria, or as having P. falciparum malaria.

Study Test  Number of false negatives % false negatives indicating 'no malaria' % false negatives indicating 'P. falciparum'
Type 2 tests
Ashton 2010ICT Combo372278
Bell 2001aICT Malaria trial 1161388
Bell 2001bICT Malaria trial 266733
Fernando 2004ICT Malaria Pf/Pv291000
Harani 2006ICT Malaria Pf/Pv36733
Singh 2000aICT Malaria Pf/Pv136238
Singh 2010Malascan186733
Tjitra 1999ICT Malaria Pf/Pv87525
van den Broek 2006NOW malaria ICT726733
Wongsrichanalai 2003ICT Malaria Pf/Pv96733
van den Broek 2006OptiMAL-IT347426
Median (range)67 (13 to 100)33 (0 to 88)
Pooled estimate (95% CI)*65 (43 to 81)35 (19 to 57)
Type 3 tests
Ashton 2010Carestart372278
Ashton 2010Parascreen431486
Bendezu 2010Parascreen198416
Bharti 2008First response71000
Dev 2004Diamed OptiMAL31000
Eibach 2013CareStart31000
Elahi 2013Parascreen56040
Kosack 2013SD Bioline1338911
Moges 2012Carestart388911
Ratsimbasoa 2007SD Malaria Antigen Bioline41000
Singh 2010Parascreen135446
Singh 2010First response93367
Singh 2010ParaHIT Total48928
Trouvay 2013SD Malaria Ag Pf/Pan187822
Yan 2013Pf/Pan Device242575
Median (range)84 (14 to 100)16 (0 to 86)
Pooled estimate (95% CI)74 (52 to 88)26 (12 to 48)
Type 4 tests
Andrade 2010OptiMAL-IT000
Chayani 2004OptiMAL31000
Dev 2004SD Malaria21000
Kolaczinski 2004OptiMAL231000
Metzger 2011OptiMAL-IT301000
Pattanasin 2003OptiMAL-IT266535
Ratsimbasoa 2007OptiMAL-IT21000
Ratsimbasoa 2007Carestart Malaria33367
Singh 2003OptiMAL (field)000
Soto Tarazona 2004OptiMAL31000
Valecha 2003OptiMAL137723
Median (range)100 (0 to 100)0 (0 to 67)
Pooled estimate (95% CI)87 (79 to 92)13 (8 to 21)
Type 3 tests

There were 25 evaluations of Type 3 RDTs verified with microscopy (Figure 5); eight were undertaken in Asia, 15 in Africa and two in South America. The median sample size was 200 (range 30 to 2585), the median prevalence of non-falciparum only malaria was 10% (range 7% to 36%) and the median percentage of malaria that was non-falciparum was 36% (range 17% to 85%). None of the evaluations were undertaken only in children under the age of five years. Five different test brands were evaluated: Parascreen (14), SD Malaria Antigen Bioline (four), Carestart Pf/Pan (four), First Response Malaria Combo (two) and One Step Malaria Pf/Pan (one). Sensitivities of the tests ranged from 25% to 100%; specificities ranged from 94% to 100%. Two studies evaluated two brands and so one brand was selected at random for inclusion in the meta-analysis. Therefore, based on 23 evaluations (11,234 participants), the pooled sensitivity was 78% (95% CI 69% to 84%) and the specificity was 99% (95% CI 98% to 99%) (Figure 6). Of the false negative RDT results (where microscopy identified non-falciparum malaria only, but RDT gave a different result), 74% (52% to 88%) of RDT results indicated 'no malaria'; the remaining false negative RDT results indicated P. falciparum or mixed infection (Table 4).

Figure 5.

Figure 5.

Forest plot of commercial brands of Type 3 tests for detection of non-falciparum species (verified with microscopy). We ordered studies by continent, age group and study identifier.

Figure 6.

Figure 6.

Summary ROC plot of Type 3 tests for detection of non-falciparum species (verified with microscopy). The black solid circle corresponds to the summary estimate of sensitivity and specificity, and is shown with a 95% confidence region.

Type 4 tests

There were 11 evaluations of Type 4 RDTs compared microscopy (Figure 7); six were undertaken in Asia, two in Africa and three in South America. The median sample size was 289 (range 80 to 896), the median prevalence of non-falciparum only malaria was 27% (range 8% to 33%) and the median percentage of malaria that was non-falciparum was 51% (range 21% to 100%). None of the evaluations were undertaken only in children under the age of five years. Three different test brands were evaluated: OptiMAL (six), OptiMAL-IT (four) and Carestart Malaria Pf/Pan (one). Sensitivities of the tests ranged from 63% to 100%; specificities ranged from 94% to 100%. One study evaluated two brands and so one brand was selected at random for inclusion in the meta-analysis. Based on 10 evaluations (3831 participants), the pooled sensitivity was 89% (95% CI 79% to 95%) and the specificity was 98% (95% CI 97% to 99%) (Figure 8). Of the false negative RDT results (where microscopy identified non-falciparum malaria only, but RDT gave a different result), 87% (79% to 92%) of RDT results indicated 'no malaria'; the remaining false negative RDT results indicated P. falciparum or mixed infection (Table 4).

Figure 7.

Figure 7.

Forest plot of commercial brands of Type 4 tests for detection of non-falciparum species (verified with microscopy). We ordered studies by continent, age group and study identifier.

Figure 8.

Figure 8.

Summary ROC plot of Type 4 tests for detection of non-falciparum species (verified with microscopy). The black circle corresponds to the summary estimate of sensitivity and specificity, and is shown with a 95% confidence region.

Other test types

There was one evaluation of Malariagen Malaria, a type of test that does not fit into the classification presented in Table 1. Malariagen Malaria uses antibodies to the HRP-2 antigen of P. falciparum and unspecified monoclonal antibodies for detection of pan-malarial antigens. The study (Selimuzzaman 2010) was undertaken on a sample of 262 adults in Asia and the study prevalence of non-falciparum malaria was 5%. The sensitivity of this test verified against microscopy was 92% (95% CI 62% to 100%) and the specificity was 95% (95% CI 92% to 97%).

Comparisons between RDT types

We summarised the comparison of different RDT types in Figure 9, Figure 10, Table 5 and Table 6. There was a statistically significant (P = 0.008) difference in accuracy between test types (Table 5) with Type 4 tests being significantly more sensitive than Type 2 (P = 0.01) and Type 3 (P = 0.03) (Table 6) based on indirect comparisons using all available data. Specificities were similarly high across the three test types. Few studies directly compared tests and so meta-analyses restricted to direct comparisons were not possible. The results from the only study (van den Broek 2006) that directly compared a Type 2 test and a Type 4 test were consistent with the meta-analytic finding and also demonstrated a statistically significant difference (P < 0.001) in sensitivity (Appendix 4).

Figure 9.

Figure 9.

Forest plot of Type 2, Type 3 and Type 4 tests for detection of non-falciparum species (verified with microscopy). We ordered studies by continent, age group and study identifier.

Figure 10.

Figure 10.

Summary ROC plot comparing Type 2, Type 3 and Type 4 tests for detection of non-falciparum species (verified with microscopy). The solid circles correspond to the summary estimates of sensitivity and specificity for each test type, and are shown with 95% confidence regions (dotted lines) and 95% prediction regions (dashed lines). The summary points for Type 2 and Type 3 and their 95% confidence regions are identical but the 95% prediction regions differ. The 95% prediction regions illustrate the extent of between study heterogeneity.

Table 5. Non-falciparum infections by RDT types verified by microscopy

  1. 1Likelihood ratio test for evidence of a difference in sensitivity or specificity, or both, between Types 2, 3, and 4.

    *Only one test brand (randomly selected) from each cohort is included in the analysis of each type.

RDT Type Study cohort Participants Malaria cases

Pooled sensitivity

(95% CI) (%)

Pooled specificity

(95% CI) (%)

 Test1
Type 211687995878 (73 to 82)99 (97 to 99)P = 0.008
Type 32311,234153778 (69 to 85)99 (98 to 99)
Type 410383198690 (79 to 95)98 (97 to 99)
Other type12621292 (62 to 100)95 (92 to 98) 
Table 6. Comparisons of RDT types for non-falciparum infections verified by microscopy

  1. We computed the ratio of sensitivities and specificities by division of the sensitivity and specificity for the column by the sensitivity and specificity for the row. If the ratio of sensitivities is greater than one, the sensitivity of the test for the column is higher than that for the row; if less than one, the sensitivity of the test in the row is higher than in the column. The same applies to the ratio of specificities.

Ratio of sensitivity

(95% CI),

P value for comparison

Ratio of specificity

 (95% CI),

P value for comparison 

  Type 2 Type 3
Studies (participants)11 (6879)23 (11,234)
  Studies (participants)

Sensitivity  (95% CI)

Specificity  (95% CI)

78 (73 to 82)

99 (97 to 99)

78 (69 to 84)

99 (98 to 99)

Type 211 (6879)

78 (73 to 82)

99 (97 to 99)

--
Type 323 (11,234)

78 (69 to 84)

99 (98 to 99)

1.00 (0.89 to 1.12), P = 1.00

1.00 (0.99 to 1.01), P = 0.87

-
Type 410 (3831)

90 (79 to 95)

98 (97 to 99)

0.87 (0.78 to 0.96), P = 0.01

1.00 (0.99 to 1.02), P = 0.52

0.87 (0.76 to 0.99), P = 0.03

1.01 (1.00 to 1.02), P = 0.29

Comparison of brands

We compared the test performance of three Type 3 test brands—Parascreen (14 studies, 547 participants), Carestart Pf/Pan (four studies, 3544 participants) and SD Malaria Antigen Bioline (four studies, 3769 participants). We excluded the other two brands—First Response Malaria Combo (two studies, 663 participants) and One Step Malaria Pf/Pan (one study, 606 participants)—from the analysis due to limited data. There was no evidence (P = 0.88) to suggest that the sensitivity or specificity, or both, of type 3 tests was associated with brand. The summary sensitivity (95% CI) was 79% (67% to 88%) for Parascreen, 74% (45% to 91%) for Carestart Pf/Pan, and 80% (73% to 85%) for SD Malaria Antigen Bioline. The summary specificity (95% CI) was 98% (98% to 99%) for Parascreen, 99% (96% to 100%) for Carestart Pf/Pan, and 99% (98% to 100%) for SD Malaria Antigen Bioline.

For Type 4 tests, we compared the diagnostic accuracy of the OptiMAL (six studies, 1843 participants) and OptiMAL-IT (four studies, 1987 participants) brands. We excluded a third brand, Carestart Pf/Pan (one study, 195 participants), because of limited data. There was no evidence (P = 0.79) to suggest a difference in the sensitivity or specificity, or both, of the two brands. The summary sensitivity of OptiMAL was 90% (85% to 93%) and that of OptiMAL-IT was 91% (49% to 99%). The summary specificities were 98% (97% to 99%) and 98% (96% to 99%) for OptiMAL and OptiMAL-IT respectively.

Investigations of heterogeneity

Due to the limited number of studies available for each test type, we were only able to investigate the effect of continent and adequacy of the reference standard on the sensitivity and specificity of Type 3 tests for detecting non-falciparum species with microscopy as reference standard. There were three continents—Africa (14 studies, 5551 participants), Asia (eight studies, 4997 participants) and South America (two studies, 704 participants)—but we excluded South America from the analysis due to the limited data available. There was no evidence (P = 0.55) to suggest a difference in sensitivity or specificity, or both, between studies conducted in Africa and those in Asia. The summary sensitivity (95% CI) was 74% (57% to 86%) for Africa and 80% (73% to 85%) for Asia. The summary specificity (95% CI) was 99% (98% to 99%) for Africa and 99% (97% to 99%) for Asia. For adequacy of the reference standard, six studies were scored 'Yes', 12 studies were scored 'No' and five studies were scored 'Unclear'; there was no evidence (P = 0.54) to suggest a difference in sensitivity or specificity, or both. The summary sensitivity and specificity were 77% (67% to 85%) and 99% (98% to 99%) for studies with an acceptable reference standard; 78% (65% to 88%) and 99% (98% to 99%) for studies without an acceptable reference standard; and 86% (78% to 91%) and 98% (97% to 99%) for studies where the assessment was judged to be unclear.

Verified by PCR
Type 2 tests

No study verified a Type 2 test with PCR.

Type 3 tests

There were five evaluations of a Type 3 test verified with PCR (Figure 11); three were undertaken in Asia and two were undertaken in South America. The median sample size was 327 (range 178 to 606), and the median prevalence of non-falciparum malaria was 15% (range 7% to 33%). None of the evaluations were undertaken only in children under the age of five years. Four different test brands were evaluated; Parascreen (two studies); SD Malaria Antigen Bioline (one study), CareStart Pf/Pan (one study) and One Step Malaria Pf/Pan (one study). Sensitivities of the tests ranged from 64% to 91% and specificities ranged from 97% to 100%. In meta-analysis, the pooled sensitivity was 81% (95% CI 72% to 88%) and the pooled specificity was 99% (95% CI 97% to 99%).

Figure 11.

Figure 11.

Summary ROC plot of Type 3 tests for detection of non-falciparum species (verified with PCR). The solid circles correspond to the summary estimate of sensitivity and specificity, and is shown with a 95% confidence region.

Type 4 tests

One study (Rakotonirina 2008) verified a Type 4 test, OptiMAL, against PCR and gave results consistent with the summary results of the six studies that used microscopy as the reference standard (Appendix 5).

Comparison of results verified by microscopy or PCR

Four studies used both microscopy and PCR as reference standards to verify parasitaemia. Elahi 2013 estimated a sensitivity of 91% and specificity of 99% for both PCR and microscopy; Bendezu 2010 estimated a sensitivity of 76% and specificity of 98% with PCR, and sensitivity of 77% and specificity of 99% with microscopy. The accuracy of CareStart Pf/Pan reported by Xiaodong 2013 was similar for both reference standards with sensitivity of 91% and specificity of 100%. Yan 2013 evaluated One Step Malaria Pf/Pan with an estimated sensitivity of 72% when verified against PCR and 70% against microscopy, and a specificity of 97% with PCR and 99% with microscopy. Ratsimbasoa 2008 verified the Malaria Antigen Bioline test against PCR and gave results within the 95% CI of the pooled results of the two studies that used microscopy as the reference standard (Appendix 5).

Target condition: P. vivax

In this section we present the results for RDTs which identify P. vivax by the presence of a positive P. vivax specific antibody line. The majority of the tests had two test lines, an HRP-2 line to detect P. falciparum and an pLDH line to detect P. vivax. One study, which verified results using PCR, evaluated a Type 6 tests, with additional test with an additional pan line to detect all species of malaria. In each case, only the Pv PLDH line is considered in the analysis.

Verified by microscopy

Eight studies evaluated the performance of Pf HRP-2 and Pv pLDH antibody tests verified with microscopy—four were undertaken in Africa and four in Asia (Figure 12). The median sample size was 361 (range 240 to 1092), with a median prevalence of P. vivax malaria of 19% (range 2% to 45%). Evaluations were conducted in mixed age groups or adults only. Five different test brands were assessed: CareStart Pf/Pv (three), Falcivax (two), Biotech Malaria Pf/Pv (one), OnSite Pf/Pv (one), and Pf/Pv Malaria Device (one). The sensitivities of the tests ranged from 66% to 100%, and specificities ranged from 98% to 100%. In meta-analysis (eight evaluations, 3682 participants) the summary sensitivity and specificity (95% CI) were 95% (86% to 99%) and 99% (99% to 100%) respectively (Figure 13).

Figure 12.

Figure 12.

Forest plot of Pf HRP-2 and Pv pLDH for detection of P. vivax (verified with microscopy). Studies are ordered by continent, age group and study identifier.

Figure 13.

Figure 13.

Summary ROC plot Pf HRP-2 and Pv pLDH for detection of P. vivax (verified with microscopy). The black circle corresponds to the summary estimate of sensitivity and specificity, and is shown with a 95% confidence region.

Verified by PCR

Two studies evaluated the performance of three different brands of Pf HRP-2 and Pv pLDH antibody tests against PCR. One study was undertaken in Bangladesh and the other in China. Sensitivities ranged from 59% (47% to 70%) to 77% (56% to 91%) and specificities ranged from 97% (95% to 99%) to 100% (99% to 100%). One study evaluated a Type 6 RDT and reported a sensitivity of 90% (70% to 99%) and specificity of 100% (99% to 100%).

Additional analyses
Sensitivities of tests at different levels of P. vivax parasitaemia
Type 2 tests

Four studies presented additional data relating to the sensitivity of Type 2 RDTs against microscopy at different levels of parasitaemia (Fernando 2004; Tjitra 1999; van den Broek 2006; Wongsrichanalai 2003). The findings varied; all found very low sensitivities below 100 parasites per µL, rising with level of parasitaemia, but the level at which a high sensitivity (over 90%) was achieved varied between 500 parasites per µL and 5,000 parasites per µL.

Type 3 tests

Four studies presented additional data relating to the sensitivity of a Type 3 RDT against microscopy at different levels of parasitaemia. In Ratsimbasoa 2008 sensitivity was 93% at levels of 501 to 5000 asexual parasites per µL; and 100% at levels above 5000 asexual parasites per µL. In Mohon 2012, sensitivity ranged from 80% at 1 to 100 asexual parasites per µL, to 90% at 101 to 500 asexual parasites per µL to 100% at 501 or more asexual parasites per µL. In Yan 2013, sensitivity was 73.3% at under 500 asexual parasites per µL to 100%, and 69% at over 500 asexual parasites per µL to 100%. In Kosack 2013 sensitivity was 14% at one to nine asexual parasites per 100 fields, 70% at one to 10 asexual parasites in 10 fields, 96% at one to 10 asexual parasites per field, and 98% at more than 10 asexual parasites per field.

Type 4 tests

Three studies presented additional data relating to the sensitivity of Type 4 RDTs against microscopy at different levels of parasitaemia, although two had only small numbers. One study presented useful data (Valecha 2003), reporting a sensitivity of 30% at under 500 asexual parasites per µL; 48% at 500 to 999 asexual parasites per µL; 91% at 1000 to 5000 asexual parasites per µL; and 100% at over 5000 asexual parasites per µL.

Summary of findings

Summary of findings. Performance of RDTs for diagnosis of non-falciparum or P. vivax malaria
Patients/populationsPeople presenting with symptoms suggestive of uncomplicated malaria 
Prior testingNone
SettingsAmbulatory healthcare settings in P. vivax,P. malariae or P. ovale malaria endemic areas in Asia, Africa and South America
Index testsImmunochromatography-based rapid diagnostic tests (RDTs) for non-falciparum malaria in the absence of P. falciparum co-infection, or P. vivax malaria with or without other malaria species 
Reference standardConventional microscopy, polymerase chain reaction (PCR)
ImportanceAccurate and fast diagnosis allows appropriate and quick treatment for malaria to be provided
Studies37 unique publications reporting 47 studies (22,862 participants)
Quality concernsPoor reporting of patient characteristics, sampling method and reference standard methods were common concerns
Test type

Quantity of evidence

Number of evaluations (malaria cases/participants)

Average sensitivity (95% CI)Average specificity (95% CI)Prevalence (%)Consequences in a cohort of 1000
Missed casesFalse positives
Target condition (reference standard): non-falciparum malaria (microscopy)

Type 2

HRP-2 (P. falciparum specific) and aldolase (pan-specific)

11 (958/6879)78% (73% to 82%)99% (97% to 99%)51110
15339
30667

Type 3

HRP-2 (P. falciparum specific) and pLDH (pan-specific)

23 (1537/11,234)78% (69% to 84%)99% (98% to 99%)51110
15339
30667

Type 4

pLDH (P. falciparum specific) and pLDH (pan-specific)

10 (986/3831)89% (79% to 95%)98% (97% to 99%)5619
151717
303314
Target condition (reference standard): non-falciparum malaria (PCR)

Type 3

HRP-2 (P. falciparum specific) and pLDH (pan-specific)

5 (300/1639)81% (72% to 88%)99% (97% to 99%)51010
15299
30577
Target condition (reference standard): P.vivax with or without other malaria species (microscopy)
HRP-2 (P. falciparum specific) and pLDH (P. vivax-specific)8 (580/3682)95% (86% to 99%)99% (99% to 100%)5310
1589
30157
Conclusions: The majority of studies evaluated RDTs which are designed to differentiate falciparum malaria from non-falciparum malaria, but cannot differentiate between different non-falciparum species or identify non-falciparum malaria species within a mixed infection. In these types of tests, specificity for non-falciparum malaria in the absence ofP. falciparum infection was high, but sensitivity was low, tests missing between 11% and 22% of non-falciparum cases. RDTs which are designed to detect P. vivax specifically, whether alone or part of a mixed infection, were more accurate with tests missing less than 5% of P. vivax cases. This review can help decision-making about which RDT to use, in combination with other published information about in vitro test performance and stability in the field.

Discussion

Summary of main results

Test Types 2, 3 and 4, and other tests that identified non-falciparum malaria through deduction of a positive result for pan-malarial antigens along with a negative result for P. falciparum specific antigens, had sensitivities that ranged in pooled analyses from 78% (Type 2) to 89% (Type 4). Further analysis of the false negative results showed that the majority of non-falciparum only cases that were missed by the RDTs were indicated as 'no malaria' although some were indicated as P. falciparum or mixed infection. Type 4 tests were significantly more sensitive than Type 2 tests. Specificities were consistently high, ranging from 98% (Type 4) to 99% (Type 2 and Type 3). There were no apparent differences between microscopy and PCR as the reference standard.

In studies that verified RDTs with microscopy, tests that used a P. vivax specific antibody line to identify P. vivax had a pooled sensitivity of 95% (95% CI 86% to 99%) and a pooled specificity of 99% (95% CI 99% to 100%). In contrast, the two studies that verified these types of RDTs with PCR demonstrated much lower sensitivity of 59% (47% to 70%) and 77% (56% to 91%).

In Summary of findings , assuming prevalences of 5%, 15% and 30%, the number of missed non-falciparum or P. vivax malaria cases and the number of false positives in a hypothetical cohort of 1000 patients are presented by test type. In the case of tests for non-falciparum only, the performance may in reality be affected by the prevalence of P. falciparum parasitaemia; this effect is not possible to estimate with any accuracy, however it is likely to be small, and has therefore been ignored.

Strengths and weaknesses of the review

Completeness of evidence

It is probable that some studies eligible for inclusion in the review were missed by our search strategy. DTA studies are known to be poorly indexed, and hence liable to be missed, even when searches are designed to be very sensitive (Whiting 2009). However, our search was comprehensive.

Accuracy of the reference standards used

Microscopy is an imperfect diagnostic test in itself, raising the possibility that in some cases of discordant results between microscopy and RDT, the RDT result may in fact have been correct, and the microscopy results incorrect. However, with the exception of P. vivax specific tests, where only two studies verified by PCR were available, results for studies which verified RDT results against PCR gave similar results to those which used microscopy as a reference standard.

In studies reporting on sensitivity by parasitaemia level, RDTs tended to reach high levels of sensitivity (above 90%) at levels of parasitaemia above 500 to 1000 asexual parasites for P. vivax, but were less reliable at lower levels. This finding corresponds closely with a similar analysis within a DTA review of RDTs for travellers with fever returning from malaria endemic to non-endemic areas( Marx 2005).

Quality of reporting of the included studies

The quality of reporting of the included studies, as assessed by the number of 'unclear' evaluations of study quality was variable. Nineteen study cohorts (40%) did not provide enough information for us to adequately assess the adequacy of the reference standard, which we judged to be the most important quality indicator for this review.

Quality of the included studies

Where sufficient information was provided to assess the quality of included studies, the quality was variable. Twenty (43%) study cohorts reported an adequate reference standard, while 37 (79%) reported that readers of the reference standard were blinded to the results of the RDTs. For Type 3 tests, we were able to investigate the effect of adequacy of the reference standard on test performance. There was no evidence of a difference in test performance between studies with an adequate, inadequate or unclear reference standard.

Completeness and relevance of the review

This review focused specifically on the use of RDTs for diagnosing non-falciparum malaria in people living in malaria endemic areas and attending ambulatory health care setting with symptoms of malaria; therefore evaluating the tests in the context in which they are intended to be most often used. Previously published reviews have evaluated the accuracy of RDTs under laboratory conditions (WHO 2012) and for use by travellers returning from malaria endemic to non-endemic areas (Marx 2005). By classifying asexual parasitaemia as positive and gametocytes only as negative we focused on malarial illness requiring curative treatment, in line with current treatment recommendations (WHO 2010). In the future, as malaria comes closer to elimination, it may become important to cure gametocytaemia to prevent transmission, and diagnostic priorities may change.

Applicability of findings to the review question

Qualities of RDTs

RDT types 2, 3 and 4, which aim to identify 'non-falciparum malaria only' as a proxy for P. vivax may miss between 11% (Type 4) and 22% (Type 2 and Type 3) of cases, with the majority of missed cases being incorrectly identified as free of malaria. In addition, the design of these tests does not allow the identification of non-falciparum malaria as part of a mixed infection, or the differentiation of P. vivax from P. ovale and P. malariae. These tests therefore do not appear adequately sensitive for the identification of P. vivax, although they may play a role in areas where both P. vivax and P. falciparum occur and are initially treated with the same drugs. In contrast, RDT types using pLDH designed to detect P. vivax specifically, whether alone or part of a mixed infection appear to be both highly sensitive (missing 5% of cases) and highly specific for P. vivax. However, two studies included in this review, which verified the test with PCR, found much lower sensitivities. Consideration also needs to be made for variation in sensitivity by brand (WHO 2012).

Application to clinical decision-making in practice

The evaluations presented in this review were conducted in patients with symptoms of clinical malaria and inferences about the results relate to this context, and not to mass surveys of well populations. The evaluations should also be read in conjunction with other published information regarding the in vitro performance, stability and costs of the tests, including the WHO FIND report (WHO 2012). Results between this review and the FIND analysis for some RDTs differ slightly. The FIND report tested individual products under laboratory conditions using standardised blood samples at low and high parasite densities (200 and 2000 parasites per µL) and reported the 'panel detection score'; which is defined as the percentage of times that two tests within a batch detected parasites at low density, and percentage of times that one test detected parasites at high density. This measure is slightly different to sensitivity, as it includes an aspect of consistency, whereas the studies in this review were conducted in field conditions with patients, and this is likely to account for variations between the datasets. The results in our review more closely mimic the conditions in which the tests would be used in practice; where parasite density is generally unknown, and may be affected by storage of the test, quality of a specific batch, local parasite densities, local parasite antigen patterns, quality of local microscopy and accuracy of reading the tests. Equally, these factors bring in more variation than tests from a laboratory using standardised samples.

RDTs can only influence clinical practice if the results are believed and acted upon. There may be reluctance on the part of both health providers and patients to believe negative RDT results, leading to unnecessary repeat testing and prescription of antimalarials for negative cases (Tavrow 2000). Various studies have shown that patients with fever and negative malaria test results, whether by microscopy or RDT, often still receive antimalarials (Hamer 2007), thus reducing their potential usefulness and cost-effectiveness. However, some educational interventions have been shown to be effective in reducing prescriptions for antimalarials in negative cases (Ngasala 2008).

Authors' conclusions

Implications for practice

RDT types 2, 3 and 4, which aim to identify 'non-falciparum malaria only' as a proxy for P. vivax are limited by their design as they are unable to identify P. vivax specifically or to identify any species of non-falciparum malaria as part of mixed infection. In addition, they have a relatively low sensitivity for 'non-falciparum malaria only'. They may be useful in areas where the majority of malaria is caused by P. falciparum or mixed infection and where good quality microscopy is not available; our related review (Abba 2011) has shown that these test types are sensitive for the detection of P. falciparum. RDT types which are designed to detect P. vivax specifically, whether alone or part of a mixed infection appear to be both more directly applicable to practice in P. vivax endemic areas and in the majority of published studies have been shown to be more accurate. Data were insufficient to determine test accuracy by parasite density, which will affect the sensitivity and specificity thresholds that decide whether a test is useful in practice.

Implications for research

More studies are needed to assess the accuracy of the newer RDT types designed to detect P. vivax specifically, particularly in areas with low prevalence.

Acknowledgements

The academic editor for this review was Dr Karen Steingart.

We are grateful to our affiliated institutions and organizations, and to the Department of International Development (DFID), UK for research grants. We acknowledge the referees for their comments. Also, we thank Nicola Mayan and Sally Jackson for helping with data extraction.

The editorial base for the Cochrane Infectious Diseases Group is funded by UKaid from the UK Government for the benefit of developing countries.

Data

Presented below are all the data for all of the tests entered into the review.

Table Tests. Data tables by test
TestNo. of studiesNo. of participants
1 Non-falciparum species only, microscopy, Type 2, ICT Combo Cassette12383
2 Non-falciparum species only, microscopy, Type 2, ICT Malaria Pf/Pv73151
3 Non-falciparum species only, microscopy, Type 2, NOW Malaria ICT1246
4 Non-falciparum species only, microscopy, Type 2, Malascan1372
5 Non-falciparum species only, microscopy, Type 2, VIKIA Ag Pf/Pan1727
6 Non-falciparum species only, microscopy, Type 2 (All)116879
7 Non-falciparum species only, microscopy, Type 3, Parascreen145407
8 Non-falciparum species only, microscopy, Type 3, CareStart Pf/Pan43544
9 Non-falciparum species only, microscopy, Type 3, SD Malaria Antigen Bioline43769
10 Non-falciparum species only, microscopy, Type 3, First Response Malaria Combo2663
11 Non-falciparum species only, microscopy, Type 3, One Step Malaria Pf/Pan1606
12 Non-falciparum species only, microscopy, Type 3 (All)2311234
13 Non-falciparum species only, microscopy, Type 4, OptiMAL61843
14 Non-falciparum species only, microscopy, Type 4, OptiMAL-IT41987
15 Non-falciparum species only, microscopy, Type 4, Carestart1195
16 Non-falciparum species only, microscopy, Type 4 (All)103831
17 Non-falciparum species only, microscopy, Other Type, Malariagen Malaria1262
18 Non-falciparum species only, PCR, Type 3, CareStart Pf/Pan1178
19 Non-falciparum species only, PCR, Type 3, Parascreen2659
20 Non-falciparum species only, PCR, Type 3, One Step Malaria Pf/Pan1606
21 Non-falciparum species only, PCR, Type 3, SD Malaria Antigen Bioline1196
22 Non-falciparum species only, PCR, Type 3 (All)51639
23 Non-falciparum species only, PCR, Type 4, OptiMAL (All)1313
24 P. vivax, microscopy, Pf HRP-2 and Pv pLDH, Carestart Pf/Pv (All)32000
25 P. vivax, microscopy, Pf HRP-2 and Pv pLDH, Biotech Malaria Pf/Pv1250
26 P. vivax, microscopy, Pf HRP-2 and Pv pLDH, Falcivax2710
27 P. vivax, microscopy, Pf HRp-2 and Pv pLDH, Onsite Pf/Pv2710
28 P. vivax, microscopy, Pf HRP-2 and Pv pLDH, Pf/Pv Malaria Device1350
29 P. vivax, microscopy, Pf HRP-2 and Pv pLDH (All)83682
30 P. vivax, PCR, Pf HRP-2 and Pv pLDH, Falcivax1338
31 P. vivax, PCR, Pf HRP-2 and Pv pLDH, OnSite Pf/Pv1338
32 P. vivax, PCR, Pf HRP-2 and Pv pLDH, Pf/Pv Malaria Device1350
33 P. vivax, PCR, Pf HRP-2 and Pv pLDH (All)2688
34 P. vivax, PCR, Type 6, PALUTOP (All)1313
Test 1.

Test 1.

Non-falciparum species only, microscopy, Type 2, ICT Combo Cassette.

Test 2.

Test 2.

Non-falciparum species only, microscopy, Type 2, ICT Malaria Pf/Pv.

Test 3.

Test 3.

Non-falciparum species only, microscopy, Type 2, NOW Malaria ICT.

Test 4.

Test 4.

Non-falciparum species only, microscopy, Type 2, Malascan.

Test 5.

Test 5.

Non-falciparum species only, microscopy, Type 2, VIKIA Ag Pf/Pan.

Test 6.

Test 6.

Non-falciparum species only, microscopy, Type 2 (All).

Test 7.

Test 7.

Non-falciparum species only, microscopy, Type 3, Parascreen.

Test 8.

Test 8.

Non-falciparum species only, microscopy, Type 3, CareStart Pf/Pan.

Test 9.

Test 9.

Non-falciparum species only, microscopy, Type 3, SD Malaria Antigen Bioline.

Test 10.

Test 10.

Non-falciparum species only, microscopy, Type 3, First Response Malaria Combo.

Test 11.

Test 11.

Non-falciparum species only, microscopy, Type 3, One Step Malaria Pf/Pan.

Test 12.

Test 12.

Non-falciparum species only, microscopy, Type 3 (All).

Test 13.

Test 13.

Non-falciparum species only, microscopy, Type 4, OptiMAL.

Test 14.

Test 14.

Non-falciparum species only, microscopy, Type 4, OptiMAL-IT.

Test 15.

Test 15.

Non-falciparum species only, microscopy, Type 4, Carestart.

Test 16.

Test 16.

Non-falciparum species only, microscopy, Type 4 (All).

Test 17.

Test 17.

Non-falciparum species only, microscopy, Other Type, Malariagen Malaria.

Test 18.

Test 18.

Non-falciparum species only, PCR, Type 3, CareStart Pf/Pan.

Test 19.

Test 19.

Non-falciparum species only, PCR, Type 3, Parascreen.

Test 20.

Test 20.

Non-falciparum species only, PCR, Type 3, One Step Malaria Pf/Pan.

Test 21.

Test 21.

Non-falciparum species only, PCR, Type 3, SD Malaria Antigen Bioline.

Test 22.

Test 22.

Non-falciparum species only, PCR, Type 3 (All).

Test 23.

Test 23.

Non-falciparum species only, PCR, Type 4, OptiMAL (All).

Test 24.

Test 24.

P. vivax, microscopy, Pf HRP-2 and Pv pLDH, Carestart Pf/Pv (All).

Test 25.

Test 25.

P. vivax, microscopy, Pf HRP-2 and Pv pLDH, Biotech Malaria Pf/Pv.

Test 26.

Test 26.

P. vivax, microscopy, Pf HRP-2 and Pv pLDH, Falcivax.

Test 27.

Test 27.

P. vivax, microscopy, Pf HRp-2 and Pv pLDH, Onsite Pf/Pv.

Test 28.

Test 28.

P. vivax, microscopy, Pf HRP-2 and Pv pLDH, Pf/Pv Malaria Device.

Test 29.

Test 29.

P. vivax, microscopy, Pf HRP-2 and Pv pLDH (All).

Test 30.

Test 30.

P. vivax, PCR, Pf HRP-2 and Pv pLDH, Falcivax.

Test 31.

Test 31.

P. vivax, PCR, Pf HRP-2 and Pv pLDH, OnSite Pf/Pv.

Test 32.

Test 32.

P. vivax, PCR, Pf HRP-2 and Pv pLDH, Pf/Pv Malaria Device.

Test 33.

Test 33.

P. vivax, PCR, Pf HRP-2 and Pv pLDH (All).

Test 34.

Test 34.

P. vivax, PCR, Type 6, PALUTOP (All).

Appendices

Appendix 1. Search strategy

Search set MEDLINE EMBASE
1Exp Malaria[MeSH]Exp Malaria [Emtree]
2Exp Plasmodium [MeSH]Exp Plasmodium [Emtree]
3Malaria ti, abMalaria ti, ab
41 or 2 or 31 or 2 or 3
5Exp Reagent kits, diagnostics [MeSH]Exp Diagnostic procedures [Emtree]
6rapid diagnos* test* ti, abrapid diagnos$ test$ ti, ab
7RDT ti, abRDT ti, ab
8Dipstick* ti, abDipstick$ ti, ab
9Rapid diagnos* device* ti, abRapid diagnos$ device$ ti, ab
10MRDD ti, abMRDD ti, ab
11OptiMal ti, abOptiMal ti, ab
12Binax NOW ti, abBinax NOW ti, ab
13ParaSight ti, abParaSight ti, ab
14Immunochromatograph* ti, abImmunochromatography [Emtree]
15Antigen detection method*Antigen detection method$
16Rapid malaria antigen test*Rapid malaria antigen test$
17Combo card test* ti, abCombo card test$ ti, ab
18Immunoassay [MeSH]Immunoassay [Emtree]
19Chromatography [MeSH]Chromatography [Emtree]
20Enzyme-linked immunosorbent assay [MeSH]Enzyme-linked immunosorbent assay [Emtree]
21Rapid test* ti, abRapid test$ ti, ab
22Card test* ti, abCard test$ ti, ab
23Rapid AND (detection* or diagnos*) ti, abRapid AND (detection$ or diagnos$) ti, ab
245 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 235 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23
254 and 194 and 19
26Limit 20 to HumansLimit 20 to Human

Appendix 2. Data extraction: characteristics of included studies

Study IDFirst author, year of publication.
Clinical features and settingsPresenting signs and symptoms, previous treatments for malaria, clinical setting.
ParticipantsSample size, age, sex, comorbidities or pregnancy, country and locality, P. falciparum malaria endemicity, endemic malaria species, average parasite density in microscopy positive cases.
Study designWere consecutive patients enrolled retrospectively or prospectively?
Whether the sampling method was consecutive or random, or whether the method was not described but consecutive sampling was most probable.
If the study evaluated more than one RDT, how were tests allocated to individuals, or did each individual receive all the tests?
Target conditionMalaria parasitaemia.
Reference standardThe reference standard test(s) used.
If microscopy was used, who performed it, and where?
If microscopy was used, how many high power fields were looked at?
If microscopy was used, how many observers or repeats were used?
If microscopy was used, how were discrepancies between observers resolved?
Index testsThe parasite species the test was designed to detect, the commercial name, and the type of test. Batch numbers if provided. Transport and storage conditions. Details of the test operators, including any special training provided.
NotesSource of funding.

Appendix 3. Data extraction and criteria for judgement: methodological quality

Quality indicator Notes
Was the spectrum of patients representative of the spectrum of patients who will receive the test in practice?

  • 'Yes' if the inclusion criteria clearly stipulated people attending an ambulatory healthcare setting with symptoms of malaria, and the sampling method was consecutive or random.

  • 'No' if the sample was unrepresentative of people with uncomplicated malaria in general (for example, if the majority of participants also had some other presenting health problem, such as pneumonia). Where a proportion of potential participants were excluded due to recent antimalarial use, well defined comorbidities or pregnancy, the sample could be classed as representative because these groups may also be excluded from testing as normal clinical practice, depending on local policy and practice.

  • 'Unclear' if the source or characteristics of participants was not adequately described; or if the sampling method was not described.

Is the reference standard likely to correctly identify the target condition?

  • 'Yes' if microscopy was undertaken by experienced microscopists with adequate laboratory facilities. Laboratory facilities were assumed to be adequate unless the study report indicated otherwise. Slides were viewed by at least two independent observers, either for all slides or for those where there are discordant results between the index and the reference test. At least 100 microscopic fields were viewed before declaring a slide negative.

  • 'Yes' if reference standard was PCR.

  • 'No' if microscopy was undertaken by insufficiently trained individuals, by one individual only, or in a situation with inadequate equipment, or if they viewed less than 100 microscopic fields before declaring negative.

  • 'Unclear' if insufficient information was provided.

Is partial verification avoided?

  • 'Yes' if all participants who received the index test also received the reference test.

  • 'No' if not all the participants who received the index test also received the reference test.

  • 'Unclear' if insufficient information was provided to assess this.

If not all participants received the reference test, we reported how many did not.

Is differential verification avoided?

  • 'Yes' if the same reference test was used regardless of the index test results.

  • 'No' if different reference tests were used depending on the results of the index test.

  • 'Unclear' if insufficient information was provided.

If any participants received a different reference test, we reported the reasons stated for this, and how many participants were involved.

Is incorporation avoided? (the index test does not form part of the reference standard)This should be 'Yes' for all studies, as the reference standard is defined in the inclusion criteria as microscopy or PCR.
Are the reference standard test results blinded?

  • 'Yes' if the person undertaking the reference test did not know the results of the index tests, if the two tests were carried out in different places, or it was clear that the reference test was undertaken and the results recorded before the index test.

  • 'No' if the same person performed both tests, or the results of the index tests were known to the person undertaking the reference tests.

  • 'Unclear' if insufficient information was provided.

Are the index test results blinded?

  • 'Yes' if the person undertaking the index test did not know the results of the reference tests, or if the two tests were carried out in different places, or it was clear that the index test was undertaken and the results recorded before the reference test.

  • 'No' if the same person performed both tests, or the results of the index tests were known to the person undertaking the reference tests.

  • 'Unclear' if insufficient information was provided.

Were uninterpretable results reported?

  • 'Yes' if the paper stated whether there were any uninterpretable or invalid results, and how those were handled; for example whether they were repeated until a valid result was obtained, or excluded from the analysis.

  • 'No' if the number of participants presented in the analysis did not match the number of participants originally enrolled in the study, and insufficient explanation was provided for any discrepancy.

  • 'Unclear' if uninterpretable or invalid test results were not mentioned, but the number of participants presented in the analysis corresponded to the number of participants reported to be originally recruited into the study, or if insufficient information was given to permit this judgement; for example if the original number of participants recruited into the study was unclear.

We reported how many results were uninterpretable (of the total) and how these were handled in the analysis.

Were any withdrawals explained?

  • 'Yes' if it was clear that no participants were excluded from the analysis (the number participants originally enrolled was clearly stated, and corresponded to the number presented in the analysis) or if exclusions were adequately described.

  • 'No' if there were participants missing or excluded from the analysis and there was no explanation given; usually where the number of participants reported to have been enrolled and the number presented in the analysis did not correspond.

  • 'Unclear' if not enough information was given to assess whether any participants were excluded from the analysis; for example if the original number of participants recruited into the study was unclear.

We reported how many participants were excluded from the analysis.

Appendix 4. Direct comparisons between test types

Study Sensitivity (true positives/malaria cases) (%) Difference (95% CI) (%) P value Specificity (true negatives/non-cases) (%) Difference (95% CI) (%) P value
Type 2 versus Type 3
  Type 2 Type 3   Type 2 Type 3  
Ashton 201085 (209/246)85 (209/246)0 (-6.3 to 6.3)P = 1.0096 (2052/2137)96 (2060/2137)0 (-1.5 to 0.8 )P = 0.58
Eibach 201380 (4/5)60 (3/5)20.0 (-35.4 to 75.4)P = 1.0099 (716/722)99 (718/722)0 (-1.1 to 0.6)P = 0.75
Singh 201068 (39/57)77 (44/57)-8.8 (-25.0 to 7.5)P = 0.4098 (308/315)98 (309/315)0 (-2.5 to 1.9)P = 1.00
Type 2 versus Type 4
  Type 2 Type 4   Type 2 Type 4  
van den Broek 200675 (217/291)88 (256/292)-13.1 (-19.4 to -6.8)P < 0.001100 (604/605)99 (598/604)0.8 (0 to 1.7)P = 0.07
Type 3 versus Type 4
  Type 3 Type 4   Type 3 Type 4  
Dev 200471 (5/7)90 26/29-18.2 (-53.5 to 17.0)P = 0.24100 (23/23)100 (111/111)0 (Not estimable)Not estimable
Ratsimbasoa 200773 (11/15)80 (12/15)-6.7 (-36.8 to 23.5)P = 1.098 (175/179)97 (175/180)0.50 (-2.7 to 3.8)P = 1.0

We presented the difference in sensitivities and specificities between test types compared within each study as percentages. If a study evaluated more than one commercial brand of a test type on the same patients against the same reference standard, we randomly selected one brand for the comparison of test types.

Appendix 5. Comparison of microscopy and PCR reference standards for non-falciparum infections

Test type, RDT brand Microscopy PCR
Number of studies Number of participants Sensitivity (95% CI) (%) Specificity (95% CI) (%) Number of studies Number of participants Sensitivity (95% CI) (%) Specificity (95% CI) (%)
Type 3, CareStart Pf/Pan4354474 (45 to 91)99 (96 to 100)117991 (81 to 97)100 (97 to 100)
Type 3, Parascreen14540779 (67 to 88)98 (98 to 99)265984 (70 to 92)99 (97 to 100)
Type 3, One Step Malaria Pf/Pan160670 (58 to 81)99 (98 to 100)160672 (60 to 82)97 (95 to 98)
Type 3, SD Malaria Antigen Bioline4376980 (73 to 85)99 (98 to 100)119664 (41 to 83)99 (97 to 100)
Type 4, OptiMAL6184390 (85 to 93)98 (97 to 99)131388 (64 to 99)98 (96 to 99)

What's new

DateEventDescription
16 April 2015AmendedErrors in the number of malaria cases were corrected in the Summary of Findings table.

Contributions of authors

The review authors jointly developed the protocol. Katharine Abba applied inclusion criteria, oversaw the data extractions and entered the data. Yemisi Takwoingi, Sarah Donegan, Amanda Kirkham and Jon Deeks performed statistical analyses. All review authors contributed to the final manuscript.

Declarations of interest

PG is Director of Evidence Building and Synthesis Research Consortium that receives money to increase the number of evidence-informed decisions by intermediary organizations, including WHO and national decision-makers that benefit the poor in middle- and low-income countries. PG is the coordinator of a WHO Collaborating Centre for Evidence Synthesis for Infectious and Tropical Diseases; one of the Centre's aims is to help WHO in its role as an infomediary in communicating reliable summaries of research evidence to policy makers, clinicians, teachers, and the public in developing countries.

Sources of support

Internal sources

  • International Medical University, Malaysia.

    Research grant ID 134/2007

  • Liverpool School of Tropical Medicine, UK.

External sources

  • Department for International Development, UK.

    Research Programme Grant

Differences between protocol and review

In the protocol, we considered RDTs for the detection of P. falciparum and non-falciparum malaria within one Cochrane Review. However, it became apparent during production of the review that such a publication would be very large. For this reason we decided to split results for the different target conditions into two separate Cochrane Reviews.

In the protocol, we stated that in the search for eligible studies we would contact test manufacturers to identify any unpublished studies, handsearch conference proceedings and contact study authors and other experts for information on ongoing and unpublished studies. However, due to the number of citations returned by our search (over 4000) and the large size of the reviews, we did not have the resources to undertake any of these additional search methods, and the methods stated in the review reflect this.

Since the publication of the protocol, we added three additional exclusion criteria relating to study eligibility. We excluded studies if the study authors used active case detection to recruit participants, as we felt the threshold of symptoms leading to testing may be lower than for a self-selecting sample attending healthcare facilities and that this may influence the findings. We also excluded studies if they did not present sufficient data to allow us to extract or calculate absolute numbers of true positives, false positives, false negatives and true negatives, as we considered it would be distracting to the reader to present data on studies that did not contribute to the analyses. Due to resource constraints, we excluded studies if they were written in non-English languages, or if they did not provide enough information to enable a full assessment of their eligibility for the review.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Alam 2011

Clinical features and settings

Presenting signs and symptoms: Fever

Previous treatments for malaria: No explicit exclusions based on previous treatment and no information presented on previous treatment

Clinical setting: Matiranga Upazila Health Complex (UHC)

Country: Bangladesh

Malaria endemicity: Perennial transmission of malaria with 2 peaks in pre-monsoon (MarchMay) and post-monsoon (September to November) periods

Malaria endemic species: P. falciparum and P. vivax

Participants

Sample size: 338

Age: Median age was 14 years and the range was 18 months to 82 years

Sex: Both males and females eligible. 50.3% of participants were female

Co-morbidities or pregnancy: Not mentioned, either as an inclusion criteria or characteristic of included participants

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 4 RDTs: Paracheck test was performed at concurrently with the microscopy. The remaining 3 RDTs were performed using stored samples. Samples from each individual were tested by all tests.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum andP. vivax

Reference standard test(s) used: Microscopy, thick and thin smear slides and PCR

Who performed the reference standard tests, and where? 2 independent microscopists: 1 employed by the study and the other at Matiranga UHC; not reported for PCR

If microscopy was used, how many high power fields were looked at? 200 fields in the Giemsa-stained thick film

How many observers or repeats were used? 2 observers

How were discrepancies between observers resolved? By a third microscopist posted at the Khagrachari Civil Surgeon's office situated 20 km away from Matiranga UHC

Index and comparator tests

Commercial name of the test: Paracheck (Orchid Biomedical System, India), FalciVax Pf (Zephyr Biomedicals, India), Onsite Pf (CTK Biotech Inc, USA) and Onsite Pf/Pv (CTK Biotech Inc, USA)

Parasite species the test is designed to detect:

  • Paracheck: P. falciparum

  • Onsite Pf: P. falciparum

  • FalciVax: P. vivax and P. falciparum

  • Onsite Pf/Pv: P. vivax and P. falciparum

Designated type:

  • Paracheck: Type 1

  • Onsite Pf: Type 1

  • FalciVax: Type Other (HRP-2 antigen for P. falciparum and pLDH antigen for P. vivax)

  • Onsite Pf/Pv: Type Other (HRP-2 antigen for P. falciparum and pLDH antigen for P. vivax)

Batch numbers: Not provided

Transport and storage conditions: Not provided

Who performed the index test, and where? Not reported. All the RDTs were used following the manufacturer's instructions.

Follow-up 
Notes Source of funding: funded by icddr,b and its donors. Paracheck provided by NMCP; Onsite Pf and Onsite Pf/Pv provided by CTK Biotech Inc, USA as a donation.
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearFebrile patients referred to microscopy for malaria diagnosis. Other characteristics, inclusion and exclusion criteria not described.
Acceptable reference standard?
All tests		Yes

Microscopy: 2 experienced, independent microscopists assessed each slide. There was provision for a third microscopist to resolve any disagreement between them. 200 fields were viewed, another 200 fields were viewed if malaria was identified, to identify mixed infections.

PCR is also a reference standard.

Partial verification avoided?
All tests		YesAll participants receiving index tests had their diagnosis verified by reference test.
Differential verification avoided?
All tests		YesThe same reference tests were used regardless of the index test results.
Incorporation avoided?
All tests		YesThe reference standard was microscopy and PCR.
Reference standard results blinded?
All tests		UnclearBlinding not described.
Index test results blinded?
All tests		UnclearBlinding not described.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesThe number recruited into the study was clearly stated and corresponded with the number included in the analysis, therefore there were no withdrawals.

Andrade 2010

Clinical features and settings

Presenting signs and symptoms: Malaria-related symptoms

Previous treatments for malaria: Not mentioned, either as an inclusion criteria or characteristic of included participants

Clinical setting: Diagnostic centres of the Brazilian National Foundation of Health (FUNASA)

Country: Brazil

Malaria endemicity: Not stated

Malaria endemic species:  P. falciparum and P. vivax

Participants

Sample size: 311

Age: Median age was 33.5 years and the range was 4 to 65 years

Sex: Both males and females eligible. 60.5% of participants were male

Co-morbidities or pregnancy: Not mentioned, either as an inclusion criteria or characteristic of included participants

Study designParticipants were recruited consecutively. The sampling method was not described. 1 RDT was evaluated.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax malaria

Reference standard test(s) used: Microscopy thick and thin blood films and nested PCR

Who performed the reference standard tests, and where? Experienced malaria field microscopists from the FUNASA performed microscopy; not stated who performed the nested PCR. All tests were repeated and confirmed at the main laboratory at the Centro de Pesquisas Goncalo Moniz, Bahia, Brazil.

If microscopy was used, how many high power fields were looked at? Not stated

How many observers or repeats were used? 2 repeats with 2 different observers

How were discrepancies between observers resolved? Not stated

Index and comparator tests

Commercial name of the test: Optimal-IT RDT (DiaMed China Ltd, Hong Kong, China)

Parasite species the test is designed to detect: P. falciparum and P. vivax malaria

Designated type: Antigens test detects stated

Batch numbers: Not stated

Transport and storage conditions: Not stated

Who performed the index test, and where? Not stated

Follow-upNot applicable
Notes Source of funding: FINEP (010409605)/FNDCT-CT Amazônia.
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesPatients were attending a clinic with symptoms of malaria. Study authors excluded people who had lived in the area for less than 6 months or had received antimalarials in the last 2 weeks.
Acceptable reference standard?
All tests		Unclear2 independent microscopists performed microscopy, 1 in the field and 1 in the central laboratory. The number of fields viewed is not stated.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference tests.
Differential verification avoided?
All tests		YesThe same reference tests were used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		UnclearNot reported whether the tests were read blindly.
Index test results blinded?
All tests		UnclearNot reported whether the tests were read blindly.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals.

Ashton 2010

Clinical features and settings

Presenting signs and symptoms: Symptoms of uncomplicated malaria (axillary temperature > 37.5°C or report of fever in the previous 48 hours)

Previous treatments for malaria: Not mentioned, either as an inclusion criteria or characteristic of included participants

Clinical setting: 1 health centre and 3 health posts per woreda

Country: Ethiopia

Malaria endemicity: Not stated

Malaria endemic species:  P. falciparum and P. vivax

Participants

Sample size: 2400

Age: All ages over 6 months eligible. Actual age profile of participant population not presented.

Sex: Both males and females eligible. Actual proportions of males and females in the participant population not stated.

Co-morbidities or pregnancy: Patients with any life-threatening diseases were excluded. No exclusion criteria based on pregnancy. No details about the frequency of pregnancy in the patient population are presented.

Study designEnrolment was consecutive and prospective. 3 RDTs were evaluated (CareStart®, ParaScreen® and ICT Combo®). Each individual received all the tests.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax malaria

Reference standard test(s) used: Microscopy thick and thin blood films

Who performed the reference standard tests, and where? Staff at the health centre and experienced microscopists at a regional malaria reference laboratory who was blinded to the initial results. And a third, blinded, reading was conducted to address discrepancies

If microscopy was used, how many high power fields were looked at? 200 fields at 1000× magnification

How many observers or repeats were used? 2

How were discrepancies between observers resolved? They were corrected according to a third, blinded, readings: presence or absence of asexual parasites, difference in species, or > 50% difference in parasite count. Microscopy results and parasite counts were corrected according to the third reading.

Index and comparator tests

Commercial name of the test:

  • CareStart® pf-HRP2/pan-pLDH (AccessBio, USA, catalogue number G0131SK)

  • ParaScreen® pf-HRP2/pan-pLDH (Zephyr Biomedicals, India, catalogue number 50310025)

  • ICT Combo® pf-HRP2/pan-aldolase (ICT Diagnostics, South Africa, catalogue number ML02)

Parasite species the test is designed to detect: Multi-species

Designated type:

  • CareStart and ParaScreen – Type 3

  • ICT Combo – Type 2

Batch numbers: Not stated

Transport and storage conditions:
"RDTs were transported unrefrigerated by air to Addis Ababa, where they were stored at ambient conditions until transfer to field sites. Temperature was monitored (Tinytag, Gemini Data Loggers, UK) but not controlled while RDTs were transported by road to health centres and during storage at the health centres. Temperatures during transport reached a maximum 36°C, but at health facilities temperatures did not exceed 30°C."

Who performed the index test, and where? Health extension workers or nurses at the health centres

Follow-upNot applicable 
Notes Source of funding: "United States Agency for International Development (Cooperative Agreement 663-A-00-09-00404-00). BC is funded by the ACT Consortium which is supported by a grant from the Bill & Melinda Gates Foundation to the London School of Hygiene and Tropical Medicine. Manufacturers supplied CareStart and ParaScreen RDTs free of charge for this evaluation, and ICT Combo was provided at a reduced price."
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesParticipants were visiting an outpatient department of a health centre with symptoms suggestive of malaria.
Acceptable reference standard?
All tests		Yes2 independent microscopists viewed the slides, a third viewed any discrepancies; 200 fields were looked at.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference tests were used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standards.
Reference standard results blinded?
All tests		Yes"RDT and microscopy results were read by different staff at the health centre, each blinded to the results of the other diagnostic technique".
Index test results blinded?
All tests		Yes"RDT and microscopy results were read by different staff at the health centre, each blinded to the results of the other diagnostic technique".
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals.

Bell 2001a

Clinical features and settings

Presenting signs and symptoms: History of fever, headache, chills or rigors occurring within the preceding 3 days; or more distant history of fever or non-specific signs suggestive of malaria

Previous treatment for malaria: Participants who had recently taken antimalarials were not excluded; 5% of participants reported prior antimalarial use

Clinical setting: Village health workers in 5 barangaya (districts)

Country: Philippines (Agusan del Sur Province in the northeast of the island of Maindano)

Malaria endemicity: Generally low perennial transmission, with pockets of high transmission

Malaria endemic species: P. falciparum andP. vivax

Participants

Sample size: 350

Age: Eligible age range not stated. Mean age of the participants was 19.5 years

Sex: Both males and females eligible. There were 171 male and 179 female participants.

Co-morbidities and pregnancy: Not mentioned, either an exclusion criteria or characteristic of included participants

Parasite density of microscopy positive cases: Not presented

Study designEnrolment was prospective. The sampling method was not described. 1 RDT was evaluated.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy of thick and thin blood smears

Who performed the reference standard tests, and where? An experienced local microscopist for all slides; selected slides were also read by an experienced parasitologist. Microscopy was performed in a local laboratory and hospital laboratory in Australia

If microscopy was used, how many high power fields were looked at? 100

How many observers or repeats were used? 1, except in discordant cases where RDT and microscopy results differed, all cases RDT-positive for P. vivax and 20% of cases negative by slide and RDT, in which case a second reader was used.

How were discrepancies between observers resolved? The second, off-site reading was taken as the correct 1

Index and comparator tests

Commerical name of RDT: ICT Malaria Pf/Pv (Amrad-ICT, Sydney, Australia)

Parasite(s) designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 4

Batch numbers: Not stated

Transport and storage conditions: Refrigerated until 2 weeks before use

Person(s) performing RDT: Researchers

RDT setting: Study villages

Follow-upNot applicable
Notes Source of funding: The Australian National Health and Medical Research Council.
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearAll participants had approached village health workers with symptoms suggestive of malaria, but the sampling method was not described.
Acceptable reference standard?
All tests		YesAn experienced microscopist viewed at least 100 high powered fields and discordant results were re-examined.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		Yes"slides were read by a local microscopist who was not aware of the results of the ICT tests".
Index test results blinded?
All tests		YesRDTs were performed 2 to 4 weeks before microscopy.
Uninterpretable results reported?
All tests		YesThe paper reported that there was 1 uninterpretable microscopy result.
Withdrawals explained?
All tests		UnclearThe number of participants originally enrolled in the study was not stated; therefore it is unclear whether there were any withdrawals.

Bell 2001b

Clinical features and settings

Presenting signs and symptoms: History of fever, headache, child or rigors occurring within the preceding 3 days; or more distant history of fever or non-specific signs suggestive of malaria

Previous treatment for malaria: Patients treated with antimalarials during the 4 weeks preceding the test were excluded from the analysis

Clinical setting: Health centre in Visaya

Country: Philippines (Agusan del Sur Province in the northeast of the island of Maindano)

Malaria endemicity: Generally low perennial transmission, with pockets of high transmission

Malaria endemic species: P. falciparum andP. vivax

Participants

Sample size: 113

Age: Eligible age range not stated. Mean age of the participants was 19.8 years

Sex: Both males and females eligible. There were 73 male and 40 female participants.

Co-morbidities and pregnancy: Not mentioned, either as an exclusion criteria or characteristic of included participants

Parasite density of microscopy positive cases: Not presented

Study designEnrolment was prospective. The sampling method was not described. 1 RDT was evaluated.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy of thick and thin blood smears

Who performed the reference standard tests, and where? Not stated.

Setting: Regional Health Units

If microscopy was used, how many high power fields were looked at? Not stated, but probably 100 as in the other trial reported together in the same paper

How many observers or repeats were used? Not stated

How were discrepancies between observers resolved? Not applicable

Index and comparator tests

Commerical name of RDT: ICT Malaria Pf/Pv (Amrad-ICT, Sydney, Australia)

Parasite(s) designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 4

Batch numbers: Not stated

Transport and storage conditions: Stored by barangay health workers at room temperature, averaging about 25°C for up to 6 months

Person(s) performing RDT: Barangay health workers

RDT setting: Health centre

Follow-upNot applicable
Notes Source of funding: The Australian National Health and Medical Research Council.
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearAll participants were attending a health centre with history of fever, headache, child or rigors within the preceding 3 days; more distant history of fever or non-specific signs suggestive of malaria; but the sampling method was not described.
Acceptable reference standard?
All tests		UnclearNo details given of the microscopy process.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		YesClear that blinding had taken place, as it was not possible to match up all the RDT and microscopy results by name and date.
Index test results blinded?
All tests		YesClear that blinding had taken place, as it was not possible to match up all the RDT and microscopy results by name and date.
Uninterpretable results reported?
All tests		Yes25 of 393 tests done were considered invalid because of an indistinct control band. Invalid results were excluded from the analysis.
Withdrawals explained?
All tests		YesOnly 113 microscopy results could be matched with RDT results by name and date; the others were lost from the analysis.

Bendezu 2010

Clinical features and settings

Presenting signs and symptoms: History of fever with or without chills, sweating and headache

Previous treatments for malaria: No history of anti-malarial treatment during the last 2 weeks

Clinical setting: Health facilities

Country: Peru

Malaria endemicity: "Despite a reduction of the incidence by up to 40% during the last 4 years in Peru, malaria due to P. falciparum and P. vivax remains an important public health problem, especially in the Amazon region where more than 70% of the cases of the country are reported."

Malaria endemic species:  P. falciparum and P. vivax

Participants

Sample size: 332

Age: Eligible age range not stated. Mean age was 32 ± 16 years

Sex: Not mentioned either as an inclusion criteria or a characteristic of participants

Co-morbidities or pregnancy: Not mentioned either as an inclusion criteria or a characteristic of participants

Study designEnrolment was prospective. The sampling method was not described. 1 RDT was evaluated.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax malaria

Reference standard test(s) used: Microscopy thick and thin blood films and PCR

Who performed the reference standard tests, and where? Reference standards were carried out by different staff blinded to each other result. Expert microscopy was carried out by experts in the 6 health centres; not described for PCR

If microscopy was used, how many high power fields were looked at? Not stated

How many observers or repeats were used? 10% of the slides were examined by a second expert microscopist at the reference laboratory

How were discrepancies between observers resolved? Not stated

Index and comparator tests

Commercial name of the test: ParaScreen (Zephyr Biomedical Systems)

Parasite species the test is designed to detect: P. falciparum or mixed infection, non-falciparum species only

Designated type: ParaScreen – Type 3

Batch numbers: Lot 101051

Transport and storage conditions: Not described

Who performed the index test, and where? Not stated

Follow-up 
Notes Source of funding: by The Global Fund to fight AIDS, Tuberculosis and Malaria through the - Organismo Andino de Salud - Convenio Hipolito Unanue' (Principal Recipient of the Multi-Country Malaria Project "Malaria control on the cross border areas of the Andean Region: A community based approach"-PAMAFRO), Grant Number MAA-305-G01-M; and by the Directorate General for Development Cooperation (DGCD) of the Belgian Government (framework agreement 02, 2003-2007), project 95501.
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesParticipants were attending health centres with fever and no history of malaria treatment within the last 2 weeks.
Acceptable reference standard?
All tests		NoOnly 10% of slides were viewed twice. The number of high power fields viewed before declaring a sample negative was not stated.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference tests were used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		YesReported that the tests were read blindly.
Index test results blinded?
All tests		YesReported that the tests were read blindly.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals.

Bharti 2008

Clinical features and settings

Presenting signs and symptoms: Fever or history of fever, and suspicion of malaria

Previous treatment for malaria: No exclusions based on previous treatment; it was undertaken in a remote area with no medical facilities

Clinical setting: Mobile field clinics in ten villages

Country: India (remote forested region of Jabalpur during the peak monsoon season)

Malaria endemicity: Low endemic areas with higher transmission during the monsoon

Malaria endemic species: P. falciparum andP. vivax

Participants

Sample size: 291

Age: All age groups eligible. Actual age range of participants 1 to 60 years

Sex: Both males and females eligible. Male: female ratio 1:1.15

Co-morbidities and pregnancy: No criteria based on co-morbidities or pregnancy. No details of the frequency of these conditions in the participant population presented.

Parasite density of microscopy positive cases: Range 80 to 111,920 parasites per µL, mean 8011, standard deviation 21,595

Study designEnrolment was consecutive and prospective. 1 RDT was evaluated.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy thick blood films

Who performed the reference standard tests, and where? Experienced microscopist in the laboratory of NIMR

If microscopy was used, how many high power fields were looked at? 100

How many observers or repeats were used? 1 for all samples, 2 independent readers for samples discordant between microscopy and RDT

How were discrepancies between observers resolved? Where the second reading gave a different result from the first, the results of the second reading were confirmed by a third examination by another technician

Index and comparator tests

Commerical name of RDT: First Response Combo Malaria Ag card test (Premier Medical Corporation Ltd, Mumbai, India)

Parasite(s) designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 3

Batch numbers: 61F0107

Transport and storage conditions: RDTs were stored properly, at temperature of 4°C to 30°C, and used within their shelf life

Person(s) performing RDT: Field laboratory assistants. Independent staff re-read the saved tests after 2 months and matched them with the originally recorded results

RDT setting: Field laboratory

Follow-upNot applicable
Notes Source of funding: Indian Council of Medical Research, Delhi. Test kits provided by Premier Medical Corporation Ltd.
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesParticipants were a consecutive sample of people attending mobile field clinics with fever or history of fever, and suspicion of malaria.
Acceptable reference standard?
All tests		YesAn experienced microscopist viewed at least 100 high power fields before declaring a slide negative, and results discordant with RDT were independently re-examined by a second microscopist, and a third if necessary.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		YesMicroscopy was undertaken "without reference to the RDT".
Index test results blinded?
All tests		YesRDTs were undertaken on site, and the results recorded before the microscopy results became available.
Uninterpretable results reported?
All tests		YesThe paper reported that there were no invalid results.
Withdrawals explained?
All tests		YesThe number of participants enrolled in the study was clearly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals.

Chanie 2011

Clinical features and settings

Presenting signs and symptoms: Suspected malaria: clinical symptoms of malaria, fever

Previous treatments for malaria: 12.5% of the subjects had anti-malaria treatment in the preceding month

Clinical setting: Outpatient departments of 3 health facilities

Country: Ethiopia

Malaria endemicity: High endemicity

Malaria endemic species: P. falciparum and P. vivax

Participants

Sample size: 1092

Age: Mean 22.3 (SD 12.8); range 3 months to 78 years of age

Sex: 48.57% female, 51.43% male

Co-morbidities or pregnancy: Co-morbidities and pregnancy not stated

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax

Reference standard test(s) used: Microscopy thick and thin smears

Who performed the reference standard tests, and where? Experienced malaria technicians performed the microscopic test. Location not reported (presumably at each of the participating health centres)

If microscopy was used, how many high power fields were looked at? A minimum of 100 high power fields examined on a thick smear

How many observers or repeats were used? Not stated

How were discrepancies between observers resolved? 20% of the positive and 10% of the negative slides and discordant results between RDT and microscopic tests were examined by another well experienced technician

Index and comparator tests

Commercial name of the test: CareStart Malaria Pf/Pv Combo (Access Bio Inc, New Jersey, USA)

Parasite species the test is designed to detect: P. falciparum and P. vivax

Designated type: Type Other (HRP-2 antigen for P. falciparum and pLDH antigen for P. vivax)

Batch numbers: Lot No H38 IV and Lot No H28 IV

Transport and storage conditions: Lot No H38 IV and Lot No H28 IV

Who performed the index test, and where? Experienced malaria technicians performed the index test

Follow-upNot applicable
Notes Source of funding: Addis Ababa University, The Federal Ministry of Health of Ethiopia. RDT kits were donated by Acces Bio Inc.
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesAll participants were attending primary health centres with fever and symptoms of malaria, sampling was consecutive.
Acceptable reference standard?
All tests		Yes"...discordant results between RDT and microscopic tests were examined by another well experienced technician". Experienced malaria technicians viewed 200 white blood cells or 100 fields.
Partial verification avoided?
All tests		YesCharacteristics of participants are well described and the only exclusion criterion was refusal to participate in the study.
Differential verification avoided?
All tests		YesThe same reference standard was used.
Incorporation avoided?
All tests		YesThe reference standard was microscopy.
Reference standard results blinded?
All tests		UnclearBlinding procedures not stated. However, microscopic evaluation and RDT were performed independently. Results were recorded in separate sheets.
Index test results blinded?
All tests		UnclearBlinding procedures not stated. However, microscopic evaluation and RDT were performed independently. Results were recorded in separate sheets.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesThe number recruited into the study was clearly stated, and corresponded with the number included in the analysis, therefore there were no withdrawals.

Chayani 2004

Clinical features and settings

Presenting signs and symptoms: Specific symptoms: rigor, chills, rise of high temperature and profuse sweating; or irregular fever, joint pain and jaundice

Previous treatment for malaria: No explicit exclusions based on previous treatment and no information presented on previous treatment

Clinical setting: Diagnostic and research centre (takes referrals from physicians for the diagnosis of malaria)

Country: Orissa, India

Malaria endemicity: Not stated

Malaria endemic species: In sample, 78.6% P. falciparum, 21.4% P. vivax

Participants

Sample size: 232

Age: Not mentioned, either as inclusion criteria or characteristic of participants

Sex: Not mentioned, either as inclusion criteria or characteristic of participants

Co-morbidities and pregnancy: Not mentioned, either as inclusion criteria or characteristic of participants

Parasite density of microscopy positive cases: Not presented

Study designEnrolment was prospective. The sampling method was unclear. 1 RDT was evaluated.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy thick and think blood smear

Who performed the reference standard tests, and where? Microscopists in a diagnostic and research centre

If microscopy was used, how many high power fields were looked at? 200

How many observers or repeats were used? 2 independent observers

How were discrepancies between observers resolved? A third microscopist's opinion was taken into account

Index and comparator tests

Commerical name of RDT: OptiMAL (DiaMed, AG, Cressier, Switzerland)

Parasite(s) designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 4

Batch numbers: Not stated

Transport and storage conditions: Not described

Person(s) performing RDT: Not stated

RDT setting: Not stated

Follow-upNot applicable
Notes Source of funding: Not stated
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearAll participants were attending an ambulatory clinic with rigor, chills, rise of high temperature and profuse sweating; or irregular fever, joint pain and jaundice. However the sampling method was not described.
Acceptable reference standard?
All tests		Yes2 independent microscopists viewed 200 high powered fields before declaring a slide negative.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		UnclearBlinding not described.
Index test results blinded?
All tests		UnclearBlinding not described.
Uninterpretable results reported?
All tests		NoThe number of participants originally enrolled in the study was not explicitly stated; therefore it is not possible to judge whether any were excluded from the analysis due to invalid test results.
Withdrawals explained?
All tests		UnclearThe number of participants originally enrolled in the study was not explicitly stated; therefore it is not possible to judge whether there were any withdrawals.

Dev 2004

Clinical features and settings

Presenting signs and symptoms: Fever

Previous treatment for malaria: No information presented on previous treatment; no suggestion of any exclusions based on previous treatment

Clinical setting: Malaria clinics

Country: India (Assam)

Malaria endemicity: Mesoendemic

Malaria endemic species: P. falciparum and P. vivax

Participants

Sample size: 336; but varied by RDT evaluated (10 to 139)

Age: Infants under 12 months excluded; actual age range 1 to 60 years

Sex: Both males and females eligible. Actual proportions of males and females in the participant population not stated

Co-morbidities and pregnancy: No exclusions criteria based on co-morbidities or pregnancy were stated, and no details of the frequency of these conditions in the participant population is presented.

Parasite density of microscopy positive cases: Range 300 to 350,000 parasites per µL, mean 59,842, standard deviation (SD) 78,780

Study designEnrolment was prospective. The sampling method was not described. 7 RDTs were evaluated; it is unclear how each RDT was allocated, as no participant received all the tests.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy thick and thin blood smears

Who performed the reference standard tests, and where? Technician; all positive slides and 20% of negative slides were also examined by the senior technician for confirmation of result. Setting was the laboratory at the malaria clinics

If microscopy was used, how many high power fields were looked at? 100

How many observers or repeats were used? 1 in the case of most smears judged negative by the technician. 2 in the case of 20% of those initially judged negative, and all those judged positive.

How were discrepancies between observers resolved? The judgement of the senior technician was used

Index and comparator tests

Commerical name of RDT:

  • Paracheck Pf (Orchid Biomedical Systems, Goa, India)

  • ParaSight-F (Beckton Dickinson, Franklin Lakes, NJ)

  • ParaHIT-F (Span diagnostics Ltd, Surat, India)

  • ICT Malaria Pf (ICT Diagnostics, Sydney, Australia)

  • New Pf-1 mini (Monozyme India Ltd, Secundrabad, India)

  • SD Malaria Pf/Pv (SD Diagnostics Inc, Korea)

  • Diamed OptiMAL (Flow Inc. Portlad, OR)

Parasite(s) designed to detect:

  • Paracheck Pf - P. falciparum

  • ParaSight-F - P. falciparum

  • ParaHIT-F - P. falciparum

  • ICT Malaria Pf - P. falciparum

  • New Pf-1 mini - P. falciparum

  • SD Malaria Pf/Pv - P. falciparum or mixed infection, non-falciparum malaria species only

  • Diamed OptiMAL - P. falciparum or mixed infection, non-falciparum malaria species only

Designated type:

  • Paracheck Pf - Type I

  • ParaSight-F - Type I

  • ParaHIT-F - Type I

  • ICT Malaria Pf - Type I

  • New Pf-1 mini - Type I

  • SD Malaria Pf/Pv - Type 3

  • Diamed OptiMAL - Type 4

Batch numbers: Not stated

Transport and storage conditions: Not described

Person(s) performing RDT: The laboratory attendant performed the test and recorded his or her interpretation. The test kit result was then re-read for verification by the senior technician.

RDT setting: Malaria clinic laboratory

Follow-upNot applicable
Notes Source of funding: Mian source of funding not stated. Test kits supplied by the Government of Assam.
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearAll participants were attending malaria clinics with fever; however, during the study period, 6663 blood smears were examined but only 336 were evaluated with RDT kits, and the sampling method for RDT evaluation was unclear.
Acceptable reference standard?
All tests		Unclear2 observers were used in the vast majority of cases; however, it is unclear whether the observers worked independently.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		YesMicroscopy and RDT results were compared by an independent observer.
Index test results blinded?
All tests		YesMicroscopy and RDT results were compared by an independent observer.
Uninterpretable results reported?
All tests		NoNo information presented on numbers initially allocated each RDT, so not possible to judge this.
Withdrawals explained?
All tests		UnclearNo information presented on numbers initially allocated each RDT, so not possible to judge this.

Eibach 2013

Clinical features and settings

Presenting signs and symptoms: Suspected malaria with a temperature > 37.5°C

Previous treatments for malaria: More than 90% of the patients reported receiving traditional or registered drugs, including antipyretics, antimalarials and antibiotics previously. However, the quality of drugs, the dosage and the duration of treatment remained unknown.

Clinical setting: General health centre

Country: Mali

Malaria endemicity: Hyperendemic in the peripheral villages, mesoendemic in the periurban area and hypoendemic in the city.

Malaria endemic species: 95% P. falciparum

Participants

Sample size: 727

Age: Mean 23.5 (SD 14.9) median = 21, range 1 to 60)

Sex: Not reported

Co-morbidities or pregnancy: Not reported

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 2 RDTs.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum, PAN malaria

Reference standard test(s) used: Microscopy thick and thin smears

Who performed the reference standard tests, and where? Local investigators

If microscopy was used, how many high power fields were looked at? 100

How many observers or repeats were used? Thick and thin smears were assessed by 2 local investigators, and by an expert at the Parasitology Department of the Lyon University Hospital, as a quality control

How were discrepancies between observers resolved?

Local investigators resolved all discrepancies between themselves by consensus. All discordant results between microscopy and the 2 RDTs were resolved by PCR and test characteristics were recalculated according to the PCR-corrected results.

Index and comparator tests

Commercial name of the test: VIKIA Malaria Ag Pf/Pan (IMAccess, Lyon, France), CareStart Malaria (AccessBio, USA)

Parasite species the test is designed to detect:
VIKIA Malaria Ag Pf/Pan: P. falciparum or mixed infection, non-falciparum malaria species only

CareStart Malaria: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: VIKIA Malaria Ag Pf/Pan: Type 2

CareStart Malaria: Type 3

Batch numbers: VIKIA Malaria Ag Pf/Pan: RD_MA2_110527

CareStart Malaria: G21MR

Transport and storage conditions: Not reported

Who performed the index test, and where? Local community health workers trained to use both tests .

Follow-upNot applicable
Notes

Source of funding: The study was supported by IMACCESS.

Data from the Lyon part of the study was not included as it did not match inclusion criteria.

The VIKIA Malaria Ag Pf/Pan™ test was read at different time points (15, 20, 30, 60 minutes), while the CareStart Malaria™ test was read after 20 minutes as recommended.

2 drops of blood were spotted onto filter paper, individually stored in a plastic bag and sent to the Parasitology Department of the Lyon University Hospital for PCR correction.

Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesConsecutive sample of people attending a clinic with symptoms of malaria.
Acceptable reference standard?
All tests		YesMicroscopy was undertaken by 2 trained local health workers and corrected by PCR at the Parasitology Department of the Lyon University Hospital.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference tests.
Differential verification avoided?
All tests		YesThe same reference test was used.
Incorporation avoided?
All tests		YesStandard microscopy and PCR.
Reference standard results blinded?
All tests		YesAll microscopists were blinded to the results of the RDTs.
Index test results blinded?
All tests		YesRDTs were performed immediately after sampling.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesThe number of participants enrolled was clearly stated, and the number included in the analysis corresponds to this number, indicating no withdrawals.

Elahi 2013

Clinical features and settings

Presenting signs and symptoms: Febrile patients with clinical symptoms

Previous treatments for malaria: Not described

Clinical setting: Health posts in remote border areas

Country: Bangladesh

Malaria endemicity: Endemic

Malaria endemic species: 74% P. falciparum, 26% P. vivax,P. malariae and P. ovale were also present in the area, but were not found within the study sample

Participants

Sample size: 327

Age: Not reported

Sex: Not reported

Co-morbidities or pregnancy: Not reported

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum, PAN malaria

Reference standard test(s) used: Microscopy thick and thin smears; quantitative PCR

Who performed the reference standard tests, and where? Experienced microscopists at the field sites

If microscopy was used, how many high power fields were looked at? 100

How many observers or repeats were used? 2 independent microscopists, blinded to the findings of the other

How were discrepancies between observers resolved? Where there was a discrepancy between the 2 microscopists, the sample was excluded from the study. The number excluded for this reason was not stated

Index and comparator tests

Commercial name of the test: Parascreen (Zephyr Biomedical Systems, India)

Parasite species the test is designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 3

Batch numbers: 101159

Transport and storage conditions: Not described

Who performed the index test, and where? Laboratory personnel at the Parisitology Laboratory, icddr,b

Follow-upNot applicable
Notes Source of funding: icddr,b and its donors, which provide unrestricted support to icddr,b for its operations and support. Parascreen was donated by the manufacturer.
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearRecruitment was prospective, but the sampling procedure was not stated. Samples with mixed infections or where the 2 microscopists' findings did not agree were excluded, and the number excluded was not stated.
Acceptable reference standard?
All tests		Unclear

Microscopy was undertaken by 2 experienced microscopists, but the number of fields viewed before declaring a slide negative was not stated.

PCR was also used as a separate, additional reference standard.

Partial verification avoided?
All tests		YesAll participants received both the reference test and the index test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesMicroscopy was used as the reference standard.
Reference standard results blinded?
All tests		YesMicroscopists were blinded to prior results.
Index test results blinded?
All tests		UnclearBlinding not described, however, index and reference tests were undertaken at different locations.
Uninterpretable results reported?
All tests		NoUninterpretable results were not reported on.
Withdrawals explained?
All tests		NoIt was stated that samples with mixed infection or where microscopists disagreed were excluded; however, the number of samples excluded and the original number of participants enrolled was not presented.

Endeshaw 2012a

Clinical features and settings

Presenting signs and symptoms: Clinically presumptive malaria: an axillary temperature greater than or equal to 37.5°C or

history of fever in the previous 48 hours

Previous treatments for malaria: Not stated

Clinical setting: Ten health centres

Country: Ethiopia

Malaria endemicity: The study was conducted in an area with range of transmission intensities, during the peak transmission period of malaria infection

Malaria endemic species: Not stated

Participants

Sample size: 1997. 4 RDTs were not done (reason not reported)

Age: Range: 8 months to 85 years. Mean 20.7 (SD not stated)

Sex: 56.2 male, 43.8 female

Co-morbidities or pregnancy: Patients with other known causes of non malarial febrile illnesses or serious illness were excluded. Pregnancy status not stated.

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax

Reference standard test(s) used: Microscopy, thick and thin smears

Who performed the reference standard tests, and where? Microscopy assessment was performed by experienced medical laboratory technicians

If microscopy was used, how many high power fields were looked at? Not stated

How many observers or repeats were used? Slides were also sent for expert microscopy at The Carter Center in Addis Ababa

How were discrepancies between observers resolved? Not stated

Index and comparator tests

Commercial name of the test: ParaScreen Pan/Pf (Zephyr Biomedical systems, Verna, Goa, India)

Parasite species the test is designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 3

Batch numbers: Not stated

Transport and storage conditions: Not stated

Who performed the index test, and where? The ten experienced laboratory technicians involved in this study were trained on the RDT sampling and evaluation procedures

Follow-upNot applicable
Notes

Source of funding: Not stated.

"Out of 2000 recruited patients, 1997 febrile cases were examined for malaria parasites by blood slide microscopy."

"Of the 1997 persons tested by slide, 1993 samples were also examined by ParaScreen RDT at the health centers."

Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesIn each health centre the first 200 self-presenting patients of any age and either sex who qualified as clinically presumptive malaria were recruited.
Acceptable reference standard?
All tests		UnclearSlides were evaluated by trained technicians at each site and were also sent to a central lab for expert microscopy. However, number of microscopic field was not stated.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesMicroscopy was used as reference standard.
Reference standard results blinded?
All tests		YesAlthough blind procedures for local technicians are not reported, slides were also sent for expert microscopy at a central lab where they were examined in blinded fashion.
Index test results blinded?
All tests		YesMicroscopy and ParaScreen Pan/PfH RDT were done immediately by health centre technicians.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesNumber enrolled in the study was explicitly stated as 2000, 1993 were presented in the analysis; therefore there were 7 withdrawals. These were explained as 3 who declined to participate and 4 who did not have RDT because the technicians had too much work.

Endeshaw 2012b

Clinical features and settings

Presenting signs and symptoms: Clinically presumptive malaria: an axillary temperature greater than or equal to 37.5°C or history of fever in the previous 48 hours

Previous treatments for malaria: Not stated

Clinical setting: Ten health centres

Country: Ethiopia

Malaria endemicity: The study was conducted in an area with range of transmission intensities, during the peak transmission period of malaria infection

Malaria endemic species: Not stated

Participants

Sample size: 1997. 4 RDTs were not done (reason not reported)

Age: Range: 8 months to 85 years. Mean 20.7 (SD not stated)

Sex: 56.2 male, 43.8 female

Co-morbidities or pregnancy: Patients with other known causes of non malarial febrile illnesses or serious illness were excluded. Pregnancy status not stated.

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax

Reference standard test(s) used: Microscopy, thick and thin smears

Who performed the reference standard tests, and where? Microscopy assessment was performed by experienced medical laboratory technicians

If microscopy was used, how many high power fields were looked at? Not stated

How many observers or repeats were used? Slides were also sent for expert microscopy at The Carter Center in Addis Ababa

How were discrepancies between observers resolved? Not stated

Index and comparator tests

Commercial name of the test: ParaScreen Pan/Pf (Zephyr Biomedical systems, Verna, Goa,India)

Parasite species the test is designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 3

Batch numbers: Not stated

Transport and storage conditions: Not stated

Who performed the index test, and where? The ten experienced laboratory technicians involved in this study were trained on the RDT sampling and evaluation procedures

Follow-upNot applicable
Notes

Source of funding: Not stated.

"Out of 2000 recruited patients, 1997 febrile cases were examined for malaria parasites by blood slide microscopy."

"Of the 1997 persons tested by slide, 1993 samples were also examined by ParaScreen RDT at the health centers."

Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesIn each health centre the first 200 self-presenting patients of any age and either sex who qualified as clinically presumptive malaria were recruited.
Acceptable reference standard?
All tests		UnclearSlides were evaluated by trained technicians at each site and were also sent to a central lab for expert microscopy. However, number of microscopic fields was not stated.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesMicroscopy was used as a reference standard.
Reference standard results blinded?
All tests		YesAlthough blind procedures for local technicians are not reported, slides were also sent for expert microscopy at a central lab where they were examined in blinded fashion.
Index test results blinded?
All tests		YesMicroscopy and ParaScreen Pan/PfH RDT were done immediately by health centre technicians.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesNumber enrolled in the study was explicitly stated as 2000, 1993 were presented in the analysis; therefore there were 7 withdrawals. These were explained as 3 who declined to participate and 4 who did not have RDT because the technicians had too much work.

Endeshaw 2012c

Clinical features and settings

Presenting signs and symptoms: Clinically presumptive malaria: an axillary temperature greater than or equal to 37.5°C or

history of fever in the previous 48 hours

Previous treatments for malaria: Not stated

Clinical setting: Ten health centres

Country: Ethiopia

Malaria endemicity: The study was conducted in an area with range of transmission intensities, during the peak transmission period of malaria infection

Malaria endemic species: Not stated

Participants

Sample size: 1997. 4 RDTs were not done (reason not reported)

Age: Range: 8 months to 85 years. Mean 20.7 (SD not stated)

Sex: 56.2 male, 43.8 female

Co-morbidities or pregnancy: patients with other known causes of non malarial febrile illnesses or serious illness were excluded. Pregnancy status not stated.

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax

Reference standard test(s) used: Microscopy, thick and thin smears

Who performed the reference standard tests, and where? Microscopy assessment was performed by experienced medical laboratory technicians

If microscopy was used, how many high power fields were looked at? Not stated

How many observers or repeats were used? Slides were also sent for expert microscopy at The Carter Center in Addis Ababa

How were discrepancies between observers resolved? Not stated

Index and comparator tests

Commercial name of the test: ParaScreen Pan/Pf (Zephyr Biomedical systems, Verna, Goa, India)

Parasite species the test is designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 3

Batch numbers: Not stated

Transport and storage conditions: Not stated

Who performed the index test, and where? The ten experienced laboratory technicians involved in this study were trained on the RDT sampling and evaluation procedures

Follow-upNot applicable
Notes

Source of funding: Not stated.

"Out of 2000 recruited patients, 1997 febrile cases were examined for malaria parasites by blood slide microscopy."

"Of the 1997 persons tested by slide, 1993 samples were also examined by ParaScreen RDT at the health centers."

Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesIn each health centre, the first 200 self-presenting patients of any age and either sex who qualified as clinically presumptive malaria were recruited.
Acceptable reference standard?
All tests		UnclearSlides were evaluated by trained technicians at each site and were also sent to a central lab for expert microscopy. However, number of microscopic field have not been stated.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesMicroscopy was used as reference standard.
Reference standard results blinded?
All tests		YesAlthough blind procedures for local technicians are not reported, slides were also sent for expert microscopy at a central lab where they were examined in blinded fashion.
Index test results blinded?
All tests		YesMicroscopy and ParaScreen Pan/PfH RDT were done immediately by health centre technicians.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesNumber enrolled in the study was explicitly stated as 2000, 1993 were presented in the analysis; therefore there were 7 withdrawals. These were explained as 3 who declined to participate and 4 who did not have RDT because the technicians had too much work.

Endeshaw 2012d

Clinical features and settings

Presenting signs and symptoms: Clinically presumptive malaria: an axillary temperature greater than or equal to 37.5°C or history of fever in the previous 48 hours

Previous treatments for malaria: Not stated

Clinical setting: Ten health centres

Country: Ethiopia

Malaria endemicity: The study was conducted in an area with range of transmission intensities, during the peak transmission period of malaria infection

Malaria endemic species: Not stated

Participants

Sample size: 1997. 4 RDTs were not done (reason not reported)

Age: Range: 8 months to 85 years. Mean 20.7 (SD not stated)

Sex: 56.2 male, 43.8 female

Co-morbidities or pregnancy: Patients with other known causes of non malarial febrile illnesses or serious illness were excluded. Pregnancy status not stated.

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax

Reference standard test(s) used: Microscopy, thick and thin smears

Who performed the reference standard tests, and where? Microscopy assessment was performed by experienced medical laboratory technicians

If microscopy was used, how many high power fields were looked at? Not stated

How many observers or repeats were used? Slides were also sent for expert microscopy at The Carter Center in Addis Ababa

How were discrepancies between observers resolved? Not stated

Index and comparator tests

Commercial name of the test: ParaScreen Pan/Pf (Zephyr Biomedical systems, Verna, Goa, India)

Parasite species the test is designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 3

Batch numbers: Not stated

Transport and storage conditions: Not stated

Who performed the index test, and where? The ten experienced laboratory technicians involved in this study were trained on the RDT sampling and evaluation procedures

Follow-upNot applicable
Notes

Source of funding: Not stated.

"Out of 2000 recruited patients, 1997 febrile cases were examined for malaria parasites by blood slide microscopy."

"Of the 1997 persons tested by slide, 1993 samples were also examined by ParaScreen RDT at the health centers."

Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesIn each health centre, the first 200 self-presenting patients of any age and either sex who qualified as clinically presumptive malaria were recruited.
Acceptable reference standard?
All tests		UnclearSlides were evaluated by trained technicians at each site and were also sent to a central lab for expert microscopy. However, the number of microscopic fields was not stated.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesMicroscopy was used as reference standard.
Reference standard results blinded?
All tests		YesAlthough blind procedures for local technicians are not reported, slides were also sent for expert microscopy at a central lab where they were examined in blinded fashion.
Index test results blinded?
All tests		YesMicroscopy and ParaScreen Pan/PfH RDT were done immediately by health centre technicians.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesNumber enrolled in the study was explicitly stated as 2000, 1993 were presented in the analysis; therefore there were 7 withdrawals. These were explained as 3 who declined to participate and 4 who did not have RDT because the technicians had too much work.

Endeshaw 2012e

Clinical features and settings

Presenting signs and symptoms: Clinically presumptive malaria: an axillary temperature greater than or equal to 37.5°C or

history of fever in the previous 48 hours

Previous treatments for malaria: Not stated

Clinical setting: Ten health centres

Country: Ethiopia

Malaria endemicity: The study was conducted in an area with range of transmission intensities, during the peak transmission period of malaria infection

Malaria endemic species: Not stated

Participants

Sample size: 1997. 4 RDTs were not done (reason not reported)

Age: Range: 8 months to 85 years. Mean 20.7 (SD not stated)

Sex: 56.2 male, 43.8 female

Co-morbidities or pregnancy: Patients with other known causes of non malarial febrile illnesses or serious illness were excluded. Pregnancy status not stated.

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax

Reference standard test(s) used: Microscopy, thick and thin smears

Who performed the reference standard tests, and where? Microscopy assessment was performed by experienced medical laboratory technicians

If microscopy was used, how many high power fields were looked at? Not stated

How many observers or repeats were used? Slides were also sent for expert microscopy at The Carter Center in Addis Ababa

How were discrepancies between observers resolved? Not stated

Index and comparator tests

Commercial name of the test: ParaScreen Pan/Pf (Zephyr Biomedical systems, Verna, Goa,India)

Parasite species the test is designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 3

Batch numbers: Not stated

Transport and storage conditions: Not stated

Who performed the index test, and where? The ten experienced laboratory technicians involved in this study were trained on the RDT sampling and evaluation procedures

Follow-upNot applicable
Notes

Source of funding: Not stated.

"Out of 2000 recruited patients, 1997 febrile cases were examined for malaria parasites by blood slide microscopy."

"Of the 1997 persons tested by slide, 1993 samples were also examined by ParaScreen RDT at the health centers."

Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesIn each health centre the first 200 self-presenting patients of any age and either sex who qualified as clinically presumptive malaria were recruited.
Acceptable reference standard?
All tests		UnclearSlides were evaluated by trained technicians at each site and were also sent to a central lab for expert microscopy. However, number of microscopic field have not been stated.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesMicroscopy was used as reference standard.
Reference standard results blinded?
All tests		YesAlthough blind procedures for local technicians are not reported, slides were also sent for expert microscopy at a central lab where they were examined in blinded fashion.
Index test results blinded?
All tests		YesMicroscopy and ParaScreen Pan/PfH RDT were done immediately by health centre technicians.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesNumber enrolled in the study was explicitly stated as 2000, 1993 were presented in the analysis; therefore there were 7 withdrawals. These were explained as 3 who declined to participate and 4 who did not have RDT because the technicians had too much work.

Endeshaw 2012f

Clinical features and settings

Presenting signs and symptoms: Clinically presumptive malaria: an axillary temperature greater than or equal to 37.5°C or history of fever in the previous 48 hours

Previous treatments for malaria: Not stated

Clinical setting: Ten health centres

Country: Ethiopia

Malaria endemicity: The study was conducted in an area with range of transmission intensities, during the peak transmission period of malaria infection

Malaria endemic species: Not stated

Participants

Sample size: 1997. 4 RDTs were not done (reason not reported)

Age: Range: 8 months to 85 years. Mean 20.7 (SD not stated)

Sex: 56.2 male, 43.8 female

Co-morbidities or pregnancy: patients with other known causes of non malarial febrile illnesses or serious illness were excluded. Pregnancy status not stated.

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax

Reference standard test(s) used: Microscopy, thick and thin smears

Who performed the reference standard tests, and where? Microscopy assessment was performed by experienced medical laboratory technicians

If microscopy was used, how many high power fields were looked at? Not stated

How many observers or repeats were used? Slides were also sent for expert microscopy at The Carter Center in Addis Ababa

How were discrepancies between observers resolved? Not stated

Index and comparator tests

Commercial name of the test: ParaScreen Pan/Pf (Zephyr Biomedical systems, Verna, Goa,India)

Parasite species the test is designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 3

Batch numbers: Not stated

Transport and storage conditions: Not stated

Who performed the index test, and where? The ten experienced laboratory technicians involved in this study were trained on the RDT sampling and evaluation procedures

Follow-upNot applicable
Notes

Source of funding: Not stated.

"Out of 2000 recruited patients, 1997 febrile cases were examined for malaria parasites by blood slide microscopy."

"Of the 1997 persons tested by slide, 1993 samples were also examined by ParaScreen RDT at the health centers."

Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesIn each health centre the first 200 self-presenting patients of any age and either sex who qualified as clinically presumptive malaria were recruited.
Acceptable reference standard?
All tests		UnclearSlides were evaluated by trained technicians at each site and were also sent to a central lab for expert microscopy. However, number of microscopic field have not been stated.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesMicroscopy was used as reference standard.
Reference standard results blinded?
All tests		YesAlthough blind procedures for local technicians are not reported, slides were also sent for expert microscopy at a central lab where they were examined in blinded fashion.
Index test results blinded?
All tests		YesMicroscopy and ParaScreen Pan/PfH RDT were done immediately by health centre technicians.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesNumber enrolled in the study was explicitly stated as 2000, 1993 were presented in the analysis; therefore there were 7 withdrawals. These were explained as 3 who declined to participate and 4 who did not have RDT because the technicians had too much work.

Endeshaw 2012g

Clinical features and settings

Presenting signs and symptoms: Clinically presumptive malaria: an axillary temperature greater than or equal to 37.5°C or history of fever in the previous 48 hours

Previous treatments for malaria: Not stated

Clinical setting: Ten health centres

Country: Ethiopia

Malaria endemicity: The study was conducted in an area with range of transmission intensities, during the peak transmission period of malaria infection

Malaria endemic species: Not stated

Participants

Sample size: 1997. 4 RDTs were not done (reason not reported)

Age: Range: 8 months to 85 years. Mean 20.7 (SD not stated)

Sex: 56.2 male, 43.8 female

Co-morbidities or pregnancy: patients with other known causes of non malarial febrile illnesses or serious illness were excluded. Pregnancy status not stated.

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax

Reference standard test(s) used: Microscopy, thick and thin smears

Who performed the reference standard tests, and where? Microscopy assessment was performed by experienced medical laboratory technicians

If microscopy was used, how many high power fields were looked at? Not stated

How many observers or repeats were used? Slides were also sent for expert microscopy at The Carter Center in Addis Ababa

How were discrepancies between observers resolved? Not stated

Index and comparator tests

Commercial name of the test: ParaScreen Pan/Pf (Zephyr Biomedical systems, Verna, Goa,India)

Parasite species the test is designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 3

Batch numbers: Not stated

Transport and storage conditions: Not stated

Who performed the index test, and where? The 10 experienced laboratory technicians involved in this study were trained on the RDT sampling and evaluation procedures

Follow-upNot applicable
Notes

Source of funding: Not stated.

"Out of 2000 recruited patients, 1997 febrile cases were examined for malaria parasites by blood slide microscopy".

"Of the 1997 persons tested by slide, 1993 samples were also examined by ParaScreen RDT at the health centers."

Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesIn each health centre the first 200 self-presenting patients of any age and either sex who qualified as clinically presumptive malaria were recruited.
Acceptable reference standard?
All tests		UnclearSlides were evaluated by trained technicians at each site and were also sent to a central lab for expert microscopy. However, number of microscopic field have not been stated.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesMicroscopy was used as reference standard.
Reference standard results blinded?
All tests		YesAlthough blind procedures for local technicians are not reported, slides were also sent for expert microscopy at a central lab where they were examined in blinded fashion.
Index test results blinded?
All tests		YesMicroscopy and ParaScreen Pan/PfH RDT were done immediately by health centre technicians.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesNumber enrolled in the study was explicitly stated as 2000, 1993 were presented in the analysis; therefore there were 7 withdrawals. These were explained as 3 who declined to participate and 4 who did not have RDT because the technicians had too much work.

Endeshaw 2012h

Clinical features and settings

Presenting signs and symptoms: Clinically presumptive malaria: an axillary temperature greater than or equal to 37.5°C or history of fever in the previous 48 hours

Previous treatments for malaria: Not stated

Clinical setting: Ten health centres

Country: Ethiopia

Malaria endemicity: The study was conducted in an area with range of transmission intensities, during the peak transmission period of malaria infection

Malaria endemic species: Not stated

Participants

Sample size: 1997. 4 RDTs were not done (reason not reported)

Age: Range: 8 months to 85 years. Mean 20.7 (SD not stated)

Sex: 56.2 male, 43.8 female

Co-morbidities or pregnancy: patients with other known causes of non malarial febrile illnesses or serious illness were excluded. Pregnancy status not stated.

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax

Reference standard test(s) used: Microscopy, thick and thin smears

Who performed the reference standard tests, and where? Microscopy assessment was performed by experienced medical laboratory technicians

If microscopy was used, how many high power fields were looked at? Not stated

How many observers or repeats were used? Slides were also sent for expert microscopy at The Carter Center in Addis Ababa

How were discrepancies between observers resolved? Not stated

Index and comparator tests

Commercial name of the test: ParaScreen Pan/Pf (Zephyr Biomedical systems, Verna, Goa,India)

Parasite species the test is designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 3

Batch numbers: Not stated

Transport and storage conditions: Not stated

Who performed the index test, and where? The ten experienced laboratory technicians involved in this study were trained on the RDT sampling and evaluation procedures

Follow-upNot applicable
Notes

Source of funding: Not stated.

"Out of 2000 recruited patients, 1997 febrile cases were examined for malaria parasites by blood slide microscopy."

"Of the 1997 persons tested by slide, 1993 samples were also examined by ParaScreen RDT at the health centers."

Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesIn each health centre the first 200 self-presenting patients of any age and either sex who qualified as clinically presumptive malaria were recruited.
Acceptable reference standard?
All tests		UnclearSlides were evaluated by trained technicians at each site and were also sent to a central lab for expert microscopy. However, number of microscopic field have not been stated.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesMicroscopy was used as reference standard.
Reference standard results blinded?
All tests		YesAlthough blind procedures for local technicians are not reported, slides were also sent for expert microscopy at a central lab where they were examined in blinded fashion.
Index test results blinded?
All tests		YesMicroscopy and ParaScreen Pan/PfH RDT were done immediately by health centre technicians.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesNumber enrolled in the study was explicitly stated as 2000, 1993 were presented in the analysis; therefore there were 7 withdrawals. These were explained as 3 who declined to participate and 4 who did not have RDT because the technicians had too much work.

Endeshaw 2012i

Clinical features and settings

Presenting signs and symptoms: Clinically presumptive malaria: an axillary temperature greater than or equal to 37.5°C or history of fever in the previous 48 hours

Previous treatments for malaria: Not stated

Clinical setting: Ten health centres

Country: Ethiopia

Malaria endemicity: The study was conducted in an area with range of transmission intensities, during the peak transmission period of malaria infection

Malaria endemic species: Not stated

Participants

Sample size: 1997. 4 RDTs were not done (reason not reported)

Age: Range: 8 months to 85 years. Mean 20.7 (SD not stated)

Sex: 56.2 male, 43.8 female

Co-morbidities or pregnancy: patients with other known causes of non malarial febrile illnesses or serious illness were excluded. Pregnancy status not stated

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax

Reference standard test(s) used: Microscopy, thick and thin smears

Who performed the reference standard tests, and where? Microscopy assessment was performed by experienced medical laboratory technicians

If microscopy was used, how many high power fields were looked at? Not stated

How many observers or repeats were used? Slides were also sent for expert microscopy at The Carter Center in Addis Ababa

How were discrepancies between observers resolved? Not stated

Index and comparator tests

Commercial name of the test: ParaScreen Pan/Pf (Zephyr Biomedical systems, Verna, Goa,India)

Parasite species the test is designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 3

Batch numbers: Not stated

Transport and storage conditions: Not stated

Who performed the index test, and where? The ten experienced laboratory technicians involved in this study were trained on the RDT sampling and evaluation procedures

Follow-upNot applicable
Notes

Source of funding: Not stated.

"Out of 2000 recruited patients, 1997 febrile cases were examined for malaria parasites by blood slide microscopy."

"Of the 1997 persons tested by slide, 1993 samples were also examined by ParaScreen RDT at the health centers."

Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesIn each health centre the first 200 self-presenting patients of any age and either sex who qualified as clinically presumptive malaria were recruited.
Acceptable reference standard?
All tests		UnclearSlides were evaluated by trained technicians at each site and were also sent to a central lab for expert microscopy. However, number of microscopic field have not been stated.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesMicroscopy was used as reference standard.
Reference standard results blinded?
All tests		YesAlthough blind procedures for local technicians are not reported, slides were also sent for expert microscopy at a central lab where they were examined in blinded fashion.
Index test results blinded?
All tests		YesMicroscopy and ParaScreen Pan/PfH RDT were done immediately by health centre technicians.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesNumber enrolled in the study was explicitly stated as 2000, 1993 were presented in the analysis; therefore there were 7 withdrawals. These were explained as 3 who declined to participate and 4 who did not have RDT because the technicians had too much work.

Endeshaw 2012j

Clinical features and settings

Presenting signs and symptoms: Clinically presumptive malaria: an axillary temperature greater than or equal to 37.5°C or

history of fever in the previous 48 hours

Previous treatments for malaria: Not stated

Clinical setting: Ten health centres

Country: Ethiopia

Malaria endemicity: The study was conducted in an area with range of transmission intensities, during the peak transmission period of malaria infection.

Malaria endemic species: Not stated

Participants

Sample size: 1997. 4 RDTs were not done (reason not reported)

Age: Range: 8 months to 85 years. Mean 20.7 (SD not stated)

Sex: 56.2 male, 43.8 female

Co-morbidities or pregnancy: patients with other known causes of non malarial febrile illnesses or serious illness were excluded. Pregnancy status not stated.

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax

Reference standard test(s) used: Microscopy, thick and thin smears

Who performed the reference standard tests, and where? Microscopy assessment was performed by experienced medical laboratory technicians

If microscopy was used, how many high power fields were looked at? Not stated

How many observers or repeats were used? Slides were also sent for expert microscopy at The Carter Center in Addis Ababa

How were discrepancies between observers resolved? Not stated

Index and comparator tests

Commercial name of the test: ParaScreen Pan/Pf (Zephyr Biomedical systems, Verna, Goa, India)

Parasite species the test is designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 3

Batch numbers: Not stated

Transport and storage conditions: Not stated

Who performed the index test, and where? The ten experienced laboratory technicians involved in this study were trained on the RDT sampling and evaluation procedures

Follow-upNot applicable
Notes

Source of funding: Not stated.

"Out of 2000 recruited patients, 1997 febrile cases were examined for malaria parasites by blood slide microscopy."

"Of the 1997 persons tested by slide, 1993 samples were also examined by ParaScreen RDT at the health centers."

Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesIn each health centre the first 200 self-presenting patients of any age and either sex who qualified as clinically presumptive malaria were recruited.
Acceptable reference standard?
All tests		UnclearSlides were evaluated by trained technicians at each site and were also sent to a central lab for expert microscopy. However, number of microscopic field have not been stated.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesMicroscopy was used as reference standard.
Reference standard results blinded?
All tests		YesAlthough blind procedures for local technicians are not reported, slides were also sent for expert microscopy at a central lab where they were examined in blinded fashion.
Index test results blinded?
All tests		YesMicroscopy and ParaScreen Pan/PfH RDT were done immediately by health centre technicians.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesNumber enrolled in the study was explicitly stated as 2000, 1993 were presented in the analysis; therefore there were 7 withdrawals. These were explained as 3 who declined to participate and 4 who did not have RDT because the technicians had too much work.

Fernando 2004

Clinical features and settings

Presenting signs and symptoms: Fever or history of fever

Previous treatment for malaria: No exclusions because of prior antimalarial use, and no data presented on the frequency of recent antimalarial use in the participants

Clinical setting: A malaria research station and a malaria clinic

Country: Sri Lanka

Malaria endemicity: Not stated

Malaria endemic species: P. vivax (70%) and P. falciparum

Participants

Sample size: 328

Age: All ages above 5 years eligible; mean age 28.3 years (range 5 to 72 years)

Sex: Both males and females eligible; 64% of the participants were males

Co-morbidities and pregnancy: No exclusion criteria based on co-morbidities or pregnancy. No details of the frequency of these conditions in the participant population is presented.

Parasite density of microscopy positive cases: Not presented

Study designEnrolment was consecutive and prospective. 1 RDT was evaluated.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy thick and think blood films

Who performed the reference standard tests, and where? Trained microscopists at the clinics and in a laboratory

If microscopy was used, how many high power fields were looked at? 400

How many observers or repeats were used? 2 independent readers; 1 at the clinics and another in a laboratory

How were discrepancies between observers resolved? There were no discrepancies between the 2 microscopists

Index and comparator tests

Commerical name of RDT: ICT Malaria Pf/Pv (Amrad-ICT, Sydney, Australia)

Parasite(s) designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 2

Batch numbers: Not stated

Transport and storage conditions: Stored and used at room temperature which often exceeds 30°C

Person(s) performing RDT: The researchers

RDT setting: At the clinics

Follow-upNot applicable
Notes Source of funding: National Science Foundation, Sri Lanka
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesParticipants were a consecutive sample of people attending clinics with fever or history of fever.
Acceptable reference standard?
All tests		Yes2 independent trained microscopists viewed 400 high power fields before declaring a slide negative.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		UnclearBlinding not described.
Index test results blinded?
All tests		UnclearBlinding not described.
Uninterpretable results reported?
All tests		UnclearThe number of participants enrolled was clearly stated, and the number included in the analysis corresponds to this number, indicating no withdrawals.
Withdrawals explained?
All tests		YesThe number of participants enrolled was clearly stated, and the number included in the analysis corresponds to this number, indicating no withdrawals.

Harani 2006

Clinical features and settings

Presenting signs and symptoms: Clinical symptoms of malaria and history of fever over 37.5°C. People with known causes of fever other than malaria were excluded.

Previous treatment for malaria: Patients who had been treated for malaria in the previous 4 weeks were excluded from the study

Clinical setting: Outpatient department of a reference hospital

Country: Pakistan

Malaria endemicity: Not stated

Malaria endemic species: P. falciparum and P. vivax

Participants

Sample size: 560

Age: All age groups eligible; actual age range of included participants 2 to 73 years

Sex: Both males and females eligibles. Participants included 339 males and 221 females

Co-morbidities and pregnancy: Not mentioned, either as an inclusion criteria or characteristic of included participants

Parasite density of microscopy positive cases: Not presented

Study designEnrolment was prospective. The sampling method was not described. 1 RDT was tested
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy thick and thin blood films

Who performed the reference standard tests, and where? Senior technologist and principle author in the

Department of Pathology and Microbiology, Aga Khan University

If microscopy was used, how many high power fields were looked at? 200

How many observers or repeats were used? Unclear, 2 microscopists were used but how they divided the work between them was not described

How were discrepancies between observers resolved? Not applicable

Index and comparator tests

Commerical name of RDT: ICT Malaria Pf/Pv (Binax Inc. Portland, Maine, USA)

Parasite(s) designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 2

Batch numbers: Not stated

Transport and storage conditions: Not described

Person(s) performing RDT: The second author

RDT setting: Microbiology section of Aga Khan University

Follow-upNot applicable
Notes Source of funding: Not stated
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearAll participants were presenting at an outpatients department with symptoms of malaria and history of fever, but the sampling method was not described.
Acceptable reference standard?
All tests		Unclear2 microscopists at a University laboratory viewed 200 high power fields before declaring a slide negative; however, it is unclear how the 2 microscopists worked together.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		Yes"The microscopists were unaware of the microscopy results".
Index test results blinded?
All tests		Yes"These results were read by the second author who was blind to the microscopy results".
Uninterpretable results reported?
All tests		UnclearThe number of participants originally enrolled in the study was clearly stated, and corresponds with the number presented in the analysis; therefore there were no exclusions due to invalid results.
Withdrawals explained?
All tests		YesThe number of participants originally enrolled in the study was clearly stated, and corresponds with the number presented in the analysis; therefore there were no withdrawals due to invalid results.

Kolaczinski 2004

Clinical features and settings

Presenting signs and symptoms: Suspected malaria or febrile illness

Previous treatment for malaria: No exclusion criteria based on previous use of antimalarials, and no data on previous antimalarial use of the participants was presented

Clinical setting: Basic health units within an Afghan refugee camp

Country: Pakistan (North West Frontier Province)

Malaria endemicity: Not stated

Malaria endemic species: 80% P. vivax, 20%P. falciparum

Participants

Sample size: 499

Age: All age groups eligible for inclusion; actual age range of the participants not stated

Sex: Both males and females eligible for inclusion; actual age range of the participants not stated

Co-morbidities and pregnancy: No exclusions based on co morbidities or pregnancy, and no data presented on the frequency of these conditions in the study population

Parasite density of microscopy positive cases: Not presented

Study designEnrolment was consecutive and prospective. 1 RDT was tested.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy thick and think blood films

Who performed the reference standard tests, and where? Microscopists in the basic health units within an Afghan refugee camp and HNI's reference laboratory in Peshawar

If microscopy was used, how many high power fields were looked at? 100

How many observers or repeats were used? 2, 1 at the BHU and 1 at the reference laboratory

How were discrepancies between observers resolved? Unclear "all of the smears checked by the microscopist at each BHU were cross checked at HNI's reference laboratory at Pashawar".

Index and comparator tests

Commerical name of RDT: OptiMAL (DiaMed, AG, Cressier, Switzerland)

Parasite(s) designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 4

Batch numbers: Not stated

Transport and storage conditions: Not described

Person(s) performing RDT: Microscopists

RDT setting: Basic health units

Follow-upNot applicable
Notes Source of funding: Not stated
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesParticipants were a consecutive series of patients attending a basic health units with suspected malaria.
Acceptable reference standard?
All tests		Yes2 microscopists, 1 working in a central laboratory, viewed at least 100 high power fields before declaring a slide negative.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		NoThe index test and reference test were undertaken by the same person.
Index test results blinded?
All tests		NoThe index test and reference test were undertaken by the same person.
Uninterpretable results reported?
All tests		UnclearThe number of participants originally enrolled in the study was clearly stated, and corresponded to the number presented in the analysis: therefore there were no exclusions due to invalid test results.
Withdrawals explained?
All tests		YesThe number of participants originally enrolled in the study was clearly stated, and corresponded to the number presented in the analysis: therefore there were no withdrawals.

Kosack 2013

Clinical features and settings

Presenting signs and symptoms: Fever or a history of fever in the prior 24 hours

Previous treatments for malaria: Not reported

Clinical setting: 2 primary care clinics

Country: Myanmar

Malaria endemicity: High endemicity

Malaria endemic species: P. falciparum, P. vivax

Participants

Sample size: 2585

Age: Mean 10.9 years (SD not reported), range 0.1 to 94 years

Sex: 51.3% male, 48.7% female

Co-morbidities or pregnancy: Pregnant women were not included

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: Multi-species malaria

Reference standard test(s) used: Microscopy thick and thin smears.

Who performed the reference standard tests, and where? A laboratory technician performed the reference test. Location not reported, presumably on site

If microscopy was used, how many high power fields were looked at? At least 200 fields

How many observers or repeats were used? Slides were sent to a malaria research centre in Thailand, for external quality control

How were discrepancies between observers resolved? Not reported

Index and comparator tests

Commercial name of the test: SD Bioline Malaria Ag P.f/Pan 05FK60 (Standard Diagnostics, Kyonggi, Republic of Korea),

Parasite species the test is designed to detect: P. falciparum or mixed infection, non-falciparum species

Designated type: Type 3

Batch numbers: Not reported

Transport and storage conditions: Not reported

Who performed the index test, and where? Not reported. As patients with fever or history of fever in the past 24 hours were immediately tested, presumable the RDTs were performed at the clinics.

Follow-upNot applicable
Notes Source of funding: Source of funding not reported
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesAll non-pregnant patients visiting primary care clinics with fever or a history of fever in the prior 24 hours were included.
Acceptable reference standard?
All tests		NoIt is reported that the program follows the WHO Malaria Microscopy Quality Assurance recommendation (reference provided). 1 technician read the slide on site. 900 (450 negative and 450 positive) of 2585 slides were sent to a malaria research unit in Thailand for external control.
Partial verification avoided?
All tests		YesAll participants had their RDT results verified by microscopic reference test.
Differential verification avoided?
All tests		YesMicroscopy was used for all samples.
Incorporation avoided?
All tests		YesMicroscopy was used for all samples.
Reference standard results blinded?
All tests		YesThe laboratory technician was not aware of the RDT result when examining the smear.
Index test results blinded?
All tests		YesRDT was performed immediately. The slide for microscopic evaluation was prepared after the RDT was performed.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals.

Mekonnen 2010

Clinical features and settings

Presenting signs and symptoms: Febrile, clinically suspected for malaria

Previous treatment for malaria: No exclusions based on previous treatment, and no relevant data presented

Clinical setting: Outpatient department of a health centre

Country: Ethiopia (Jimma, South-West) - 300 km south-west of Addis Ababa, 1760 m above sea level

Malaria endemicity: Not stated: transmission takes place throughout the year

Malaria endemic species: P. falciparum and P. vivax

Participants

Sample size: 240

Age: Eligible age range not stated. Actual age range of participants was 1 to 60 years, with a mean age of 25 years

Sex: Both males and females eligible. 57.5% of the study participants were male, 42.5% female

Co-morbidities and pregnancy: Not mentioned, either as an exclusion criteria or characteristic of the included participants.

Parasite density of microscopy positive cases: Not presented

Study designEnrolment was prospective. The sampling method was not described. 1 RDT was evaluated.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy thick and thin blood films

Person(s) performing microscopy: Experienced malaria technicians

Microscopy setting: Not stated

Number of high power fields examined before declaring negative: 300

Number of observer or repeats: Discordant results between RDTs and slides were repeated.

Resolution of discrepancies between observers: Not described.

Index and comparator tests

Commerical name of RDT: CareStart Malaria Pf/Pv Combo (Access Bio Inc, Monmouth Junction, New Jersey, USA)

Parasite(s) designed to detect: P. falciparum and P. vivax

Designated type: Type 5

Batch numbers: Not stated

Transport and storage conditions: Stored according to the guidelines of the manufacturer and quality of package desiccant was checked before use

Person(s) performing RDT: Experienced malaria technicians

RDT setting: Not stated

Follow-upNot applicable
Notes Source of funding: Recieved financial support from the School of Laboratory Studies of the Jimma Univeristy and the VLIR-IUC program between Flanders and Jimma Univeristy. Access Bio Ltd donated the CareStart Malaria Pf/Pv Combo test kit
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearAll participants were attending a clinic with fever and suspected malaria, but the sampling method was not described.
Acceptable reference standard?
All tests		YesExperienced technicians independently viewed 300 high power fields before declaring a slide negative. Discordant results was repeated independently.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		YesBlinding not described.
Index test results blinded?
All tests		Yes"Results of the CareStart tests were determined prior to microscopic results with strict blinding to the microscopic examination of the blood film".
Uninterpretable results reported?
All tests		UnclearThe number of participants originally enrolled in the study was clearly stated, and corresponded to the number presented in the analysis: therefore there were no exclusions due to invalid test results.
Withdrawals explained?
All tests		YesThe number of participants originally enrolled in the study was clearly stated, and corresponded to the number presented in the analysis: therefore there were no withdrawals.

Metzger 2011

Clinical features and settings

Presenting signs and symptoms:  Not stated

Previous treatments for malaria: Not mentioned, either as an exclusion criteria or characteristic of included participants

Clinical setting: Health posts

Country: Venezuela

Malaria endemicity: "In 2007, the annual parasite index (API) was 68.4 cases/1000 inhabitants, but hot spots of higher malaria risk were seen in some indigenous ethnic groups."

Malaria endemic species: P. falciparum and P. vivax

Participants

Sample size: 550

Age: Not mentioned either as an inclusion criteria or a characteristic of participants

Sex: Not mentioned either as an inclusion criteria or a characteristic of participants

Co-morbidities or pregnancy: Not mentioned either as an inclusion criteria or a characteristic of participants

Study designNo details of the enrolment and sampling method were reported. 1 RDT was evaluated.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax

Reference standard test(s) used: microscopy

Who performed the reference standard tests, and where? Slides were examined by microscopists in health posts, then all positive and 10% of negative slides were re-examined by microscopists at the Regional Central Laboratory. Slides were then sent to the National Amazon Centre for Research and Control of Tropical Diseases in Puerto Ayacucho for re-examination by expert microscopists.

If microscopy was used, how many high power fields were looked at? In the health posts and Regional Central Laboratory 200 fields of thick blood smears, and in the National Amazon Centre for Research and Control of Tropical Diseases the complete blood smear was read before being declared negative.

How many observers or repeats were used? 3

How were discrepancies between observers resolved? Not reported

Index and comparator tests

Commercial name of the test: OptiMAL-IT (Diamed AG, Cressier sur Morat, Switzerland)

Parasite species the test is designed to detect: P. falciparum or mixed infection, non-falciparum malaria species only

Designated type: Type 4

Batch numbers: Not stated

Transport and storage conditions: Samples were transported by messengers using boat, aeroplane, motorbike, bicycle and foot transportation, sometimes taking up to 4 weeks. Due to lack of refrigerators or due to electrical power cuts, or both, samples were often exposed to local ambient conditions (study average temperature of 26.9C, with frequent peaks up to 40°C).

Who performed the index test, and where? Microscopists at health posts and expert microscopists at the Amazon Centre for Research and Control of Tropical Diseases in Puerto Ayacucho.

Follow-upNot applicable
Notes Source of funding: UNICEF
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearNo details of the characteristics of the participants were reported.
Acceptable reference standard?
All tests		Yes3 microscopists read the slides at either 200 fields or the complete smear before declaring a test as negative.
Partial verification avoided?
All tests		Yes"550 RDTs (OptiMAL-IT) ans concomitant slides originating from the HPs of Atures municipality were received in the order of their arrival at the RCL in Puerto Ayacucho".
Differential verification avoided?
All tests		YesThe same reference tests were used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		YesReported blinding.
Index test results blinded?
All tests		YesReported blinding.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore no withdrawals due to invalid results.
Withdrawals explained?
All tests		Yes"36 tests had to be excluded because coding was lost during transport and/or because they could not be clearly allocated".

Moges 2012

Clinical features and settings

Presenting signs and symptoms: Suspected malaria: fever, headache, fatigue, sweating/chills/rigors, vomiting, splenomegaly, myalgia and arthralgia, anaemia, hypoglycaemia.

Previous treatments for malaria: Patients who had received anti-malarial drugs during the past 4 weeks were excluded.

Clinical setting: Medical and paediatric out-patient departments of a health centre.

Country: Ethiopia

Malaria endemicity: High endemicity

Malaria endemic species: P. vivax and P. falciparum

Participants

Sample size: 254

Age: Mean 21.4 (SD14.76), range 0.4 to 75 years

Sex: 61% male, 39% female

Co-morbidities or pregnancy: Co-morbities are not reported. However, critically ill patients who were unable to give blood were excluded from the study.

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax

Reference standard test(s) used: Microscopy thick and thin smears

Who performed the reference standard tests, and where? The tests were performed by an experienced laboratory technician at the health centre and an experienced microscopist at a university hospital laboratory

If microscopy was used, how many high power fields were looked at? 200 fields

How many observers or repeats were used? 2 observers

How were discrepancies between observers resolved? A third of discordant results, a third expert reader was used. This third reader's results were considered final.

Index and comparator tests

Commercial name of the test: CareStart™ Malaria HRP2/pLDH COMBO (Access Bio Inc., USA)

Parasite species the test is designed to detect: P. falciparum or mixed infection, non-falciparum species only

Designated type: Type 3

Batch numbers: Not reported

Transport and storage conditions: Not reported

Who performed the index test, and where? The index test was performed at the health centre. Information on the person who performed the test is not reported.

Follow-upNot applicable
Notes Source of funding: Source of funding not reported. RDT kits were supplied by the North Gondar Zonal Health Bureau
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesSubjects with suspected malaria symptoms were recruited (all symptoms reported).
Acceptable reference standard?
All tests		YesMicroscopy evaluations were performed by 2 independent observers (200 fields). Discordant results were referred to a third observer.
Partial verification avoided?
All tests		YesAll participants receiving the index test had their diagnosis verified my microscopy.
Differential verification avoided?
All tests		YesMicroscopy was used as reference test for all samples.
Incorporation avoided?
All tests		YesThe reference standard for all samples was microscopy.
Reference standard results blinded?
All tests		YesThe microscopists were blinded to the RDT results.
Index test results blinded?
All tests		UnclearThe same finger-prick blood sample used for microscopy was used to perform the index in parallel.
Uninterpretable results reported?
All tests		UnclearThe number of participants enrolled in the study was clearly stated and corresponded to the number presented in the analysis; therefore there were no exclusions due to uninterpretable test results.
Withdrawals explained?
All tests		YesThe number of participants enrolled in the study was clearly stated and corresponded to the number included in the analysis; therefore there were no withdrawals.

Mohon 2012

Clinical features and settings

Presenting signs and symptoms: Fever

Previous treatments for malaria: Not reported

Clinical setting: Upazila Health Complexes

Country: Bangladesh

Malaria endemicity: Hypo-endemicity

Malaria endemic species: 95% P. falciparum

Participants

Sample size: 372

Age: Median 19.4, range 1.5 to 82 years

Sex: 52.8 male, 47.2% female

Co-morbidities or pregnancy:

Co-morbidities and pregnancy not reported.

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum, P. vivax

Reference standard test(s) used: Microscopy thick and thin smears, nested PCR.

Who performed the reference standard tests, and where? Microscopy was performed by experienced microscopists on site and the icddr,b laboratory

If microscopy was used, how many high power fields were looked at? Microscopy was performed following the standard procedure. Details, not reported(reference provided).

How many observers or repeats were used? 2

How were discrepancies between observers resolved? Not reported

Index and comparator tests

Commercial name of the test: OnSite (Pf /Pan) (CTK Biotech Inc, USA)

Parasite species the test is designed to detect: P. falciparum, non-falciparum, P. vivax

Designated type: Type 3

Batch numbers: Not reported

Transport and storage conditions: Not reported

Who performed the index test, and where? The index test was performed at the icddr,b Parasitology Laboratory

Follow-upNot applicable
Notes Source of funding: International Centre for Diarrheal Research Bangladesh (icddr,b)
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearFebrile patients were recruited. However, patients with mixed infections and those with discordant microscopy/PCR results were excluded and the numbers excluded for these reasons are not stated.
Acceptable reference standard?
All tests		YesMicroscopy was verified with PCR.
Partial verification avoided?
All tests		YesAll participants that received the index test had their diagnosis verified by reference test.
Differential verification avoided?
All tests		YesPCR adjusted microscopy was used as the reference test.
Incorporation avoided?
All tests		YesPCR adjusted microscopy was used as the reference test.
Reference standard results blinded?
All tests		UnclearBlinding not reported.
Index test results blinded?
All tests		UnclearBlinding not reported.
Uninterpretable results reported?
All tests		NoThe number of participants originally enrolled in the study was not explicitly stated; therefore it is unclear whether there were any exclusions due to uninterpretable test results.
Withdrawals explained?
All tests		UnclearThe number of participants originally enrolled in the study was not explicitly stated; therefore it is unclear whether there were any withdrawals.

Pattanasin 2003

Clinical features and settings

Presenting signs and symptoms: Fever or history of fever and suspected diagnosis of uncomplicated malaria

Previous treatment for malaria: No mention of previous treatment for malaria, either as an exclusion criteria or a characteristic of included participants

Clinical setting: Not stated

Country: Thailand (Mae Sod)

Malaria endemicity: Not stated, peak transmission season

Malaria endemic species: P. falciparum and P. vivax

Participants

Sample size: 271

Age: Children aged under 2 years were excluded. The study included participants aged 2 to 81 years; 71% were aged under 15 years

Sex: Male: female ratio was 1.7:1

Co-morbidities and pregnancy: Pregnant women were excluded

Parasite density of microscopy positive cases: Not presented

Study designEnrolment was prospective. The sampling method was not described. 2 RDTs were evaluated, the vast majority of participants received both RDTs.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy thick and thin blood film

Person(s) performing microscopy: Not stated

Microscopy setting: Not stated

Number of high power fields examined before declaring negative: Not stated

Number of observer or repeats: Not stated

Resolution of discrepancies between observers: Not applicable

Index and comparator tests

Commerical name of RDT:

  • Paracheck-Pf (Orchid Biomedical Systems, Goa, India)

  • OptiMAL-IT (DiaMed, AG, Cressier, Switzerland)

Parasite(s) designed to detect:

  • Paracheck-Pf - P. falciparum

  • OptiMAL-IT - P. falciparum or mixed infection, non-falciparum species only

Designated type:

  • Paracheck-Pf - Type 1

  • OptiMAL-IT - Type 4

Batch numbers: Not stated

Transport and storage conditions: Kept at room temperature and opened just before performing the test to avoid humidity

Person(s) performing RDT: Not stated

RDT setting: Not stated

Follow-upNot applicable
Notes Source of funding: Not stated
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearAll participants had a fever and suspected malaria, but the exact clinical setting and the sampling method were not described.
Acceptable reference standard?
All tests		UnclearNo details of the microscopy process were given.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		UnclearBlinding not described.
Index test results blinded?
All tests		YesTest results were recorded without reference to the microscopy results.
Uninterpretable results reported?
All tests		YesDoubtful and invalid results were reported (5 of 271).
Withdrawals explained?
All tests		UnclearAlmost all participants were reported to receive the same index and reference tests (271 participants in total, 266 received OptMAL, 269 received Paracheck-Pf); the numbers presented in the analysis correspond.

Rakotonirina 2008

Clinical features and settings

Presenting signs and symptoms: Fever over 37.5°C or history of fever in the previous 24 hours

Previous treatment for malaria: Participants with recent antimalarial use were not excluded from the study; 34% of participants declared antimalarial use

Clinical setting: 2 primary health centres

Country: Madagascar (Tsiroanomandidy on the west foothill areas of the Highlands)

Malaria endemicity: Low and predominantly seasonal

Malaria endemic species: P. falciparum (80%) andP. vivax

Participants

Sample size: 313

Age: All age groups were eligible for inclusion; the actual age range of the included participants was 6 months to 79 years (median age 10 years)

Sex: Male: female ratio was 1.2:1

Co-morbidities and pregnancy: Pregnant women were excluded, as were people with signs of severe or complicated malaria

Parasite density of microscopy positive cases: Range 32 to 52,750 parasites per µL, mean 4104, SD 7894

Study designEnrolment was consecutive and prospective. 2 RDTs were evaluated, all participants received both RDTs.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: PCR

Index and comparator tests

Commerical name of RDT:

  • OptiMAL-IT (DiaMed, AG, Cressier, Switzerland)

  • PALUTOP

Parasite(s) designed to detect:

  • OptiMAL-IT - P. falciparum or mixed infection, non-falciparum species only

  • PALUTOP - P. falciparum, P. vivax and other malaria types

Designated type:

  • OptiMAL-IT - Type 4

  • PALUTOP - Type 6

Batch numbers:

  • OptiMAL-IT - 46110.85.01

  • PALUTOP - 91014

Transport and storage conditions: Transported and maintained at the study sites (primary health centres) at room temperature and opened just before use to avoid humidity damage

Person(s) performing RDT: Trained technician

RDT setting: Primary health centres

Follow-upNot applicable
Notes Source of funding: Global Fund Project for Madagascar, Round 3
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesParticipants were a consecutive sample of patients attending primary health centres with fever or history of fever in the previous 24 hours.
Acceptable reference standard?
All tests		YesReference standard was PCR.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		YesStated that the PCR operator was blind to the results of the other tests performed.
Index test results blinded?
All tests		YesStated that the test readers were blind to the results of the other tests performed.
Uninterpretable results reported?
All tests		YesThere were no test failures with either RDT.
Withdrawals explained?
All tests		YesThe number of participants enrolled in the study is clearly stated and corresponds to the number presented in the analysis.

Ratsimbasoa 2007

Clinical features and settings

Presenting signs and symptoms: Fever over 37.5°C or history of fever in the previous 24 hours, with typical malaria symptoms. Patients with signs of severe or complicated malaria were excluded.

Previous treatment for malaria: Participants with recent antimalarial use were not excluded from the study; 17% of participants reported antimalarial use

Clinical setting: Primary health centres

Country: Madagascar. Rural areas of Mahasolo (western foothills areas of the highlands) and Saharevo (eastern foothills areas of the highlands)

Malaria endemicity: Low and predominantly seasonal in both areas

Malaria endemic species: Predominantly P. falciparum; someP. vivax

Participants

Sample size: 194

Age: All groups eligible for inclusion not stated; actual age range of the included participants was 1 to 79 years (mean age 15.2 years). 12.9% were under 5 years of age

Sex: Male: female ratio was 0.98:1

Co-morbidities and pregnancy: Pregnant women were excluded, as were people with signs of severe or complicated malaria

Parasite density of microscopy positive cases: Range 16 to 233,600 parasites per µL, mean 6564, SD 26,553

Study designEnrolment was prospective. The sampling method was not described. 2 RDTs were evaluated, all participants received both RDTs.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy thick and thin blood films

Person(s) performing microscopy: An experienced technician

Microscopy setting: Not stated

Number of high power fields examined before declaring negative: 200

Number of observer or repeats: 1

Resolution of discrepancies between observers: Not applicable

Index and comparator tests

Commerical name of RDT:

  • CareStart Malaria Pf/Pan (Access Bio Inc., Monmouth Junction, NJ)

  • SD Malaria Antigen Bioline Pf/Pan (Standard Diagnostics, Suwon City, South Korea)

  • OptiMAL-IT (DiaMed, AG, Cressier, Switzerland)

Parasite(s) designed to detect: P. falciparum or mixed infection, non-falciparum species only

Designated type: Type 4

Batch numbers:

  • CareStart Malaria - J25IL, J35IL, J45IL, J55IL

  • SD Malaria Antigen Bioline - T5001, T5002, T5003, T5004

  • OptiMAL-IT - 46110.73.01, 46110.74.01, 46110.75.01

Transport and storage conditions: Transported and maintained at the study sites (primary health centres) at room temperature and opened just before use to avoid humidity damage

Person(s) performing RDT: A technician

RDT setting: Not stated

Follow-upNot applicable
Notes Source of funding: Global Fund Project for Madagascar, Round 3. The manufacturers supplied the test kits.
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearAll participants were attending primary health centres with fever and symptoms of malaria, but the sampling method was not described.
Acceptable reference standard?
All tests		NoAn expert technician viewed 200 high power fields before declaring a slide negative; however their findings were not verified by a second independent reader.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		Yes"Analyzed without reference to the RDT results".
Index test results blinded?
All tests		YesThe RDTs were undertaken before the microscopy.
Uninterpretable results reported?
All tests		UnclearThe number recruited into the study was clearly stated, and corresponded with the number included in the analysis.
Withdrawals explained?
All tests		YesThe number recruited into the study was clearly stated, and corresponded with the number included in the analysis.

Ratsimbasoa 2008

Clinical features and settings

Presenting signs and symptoms: Fever or fever in the previous 24 hours with typical malaria symptoms

Previous treatment for malaria: Participants with recent antimalarial use were not excluded from the study; 13% of participants declared antimalarial use

Clinical setting: Primary Health Centre

Country: Madagascar (Ampasimpotsy, Central Highlands)

Malaria endemicity: Transmission is low and predominantly seasonal. This study was carried out in the low season

Malaria endemic species: P. falciparum (approximately 75%) andP. vivax

Participants

Sample size: 200

Age: Eligible age range not stated; actual age range of the included participants was 6 months to 73 years (40% under 5 years, 26.5% 5 to 15 years)

Sex: Male: female ratio was 1.2:1

Co-morbidities and pregnancy: Pregnant women were excluded, as were people with signs of severe or complicated malaria

Parasite density of microscopy positive cases: Range 16 to 285,000 parasites per µL, mean 16,757, SD 42,631

Study designEnrolment was prospective. The sampling method was not described. 2 RDTs were evaluated, all participants received both RDTs.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: PCR

Index and comparator tests

Commerical name of RDT:

  • SD Bioline Malaria Ag Pf (Standard Diagnostics Inc., Suwon City, South Korea)

  • SD Bioline Malaria Ag Pf/Pan (Standard Diagnostics Inc., Suwon City, South Korea)

Parasite(s) designed to detect:

  • SD Bioline Malaria Ag Pf - P. falciparum

  • SD Bioline Malaria Ag Pf/Pan - P. falciparum or mixed infection, non-falciparum species only

Designated type:

  • SD Bioline Malaria Ag Pf - Type 1

  • SD Bioline Malaria Ag Pf/Pan - Type 3

Batch numbers:

  • SD Bioline Malaria Ag Pf - 05FK50

  • SD Bioline Malaria Ag Pf/Pan - 05FK60

Transport and storage conditions: All tests were kept at room temperature and opened just before use to avoid humidity damage.

Person(s) performing RDT: Not stated

RDT setting: Not stated

Follow-upNot applicable
Notes Source of funding: Kozone, representing Standard Diagnostics Inc in Madagascar
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearParticipants were all attending a health centre with fever and typical symptoms of malaria, but the sampling method was not described.
Acceptable reference standard?
All tests		YesThe reference standard was PCR.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		YesPCR was carried out by technicians blind to the results of RDT testing.
Index test results blinded?
All tests		YesRDTs were undertaken before the results of PCR were known
Uninterpretable results reported?
All tests		YesUninterpretable results are reported and excluded from the analysis. There were 2 invalid results for Bioline Pf and 1 for Bioline Pf/Pan.
Withdrawals explained?
All tests		NoThere was 1 participant missing from the analysis from Bioline Pf/Pan, with no explanation.

Samane 2010

Clinical features and settings

Presenting signs and symptoms: Suspected malaria with symptoms including fever or chills of several days, or both

Previous treatments for malaria: Not mentioned, either as an exclusion criteria or characteristic of included participants

Clinical setting: Health centres

Country: Iran

Malaria endemicity: Not stated

Malaria endemic species: Not stated

Participants

Sample size: 250

Age: Not mentioned either as an inclusion criteria or a characteristic of participants

Sex: Not mentioned either as an inclusion criteria or a characteristic of participants

Co-morbidities or pregnancy: Not mentioned either as an inclusion criteria or a characteristic of participants

Study designEnrolment was prospective. The sampling method was not described. 1 RDT was evaluated.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum andP. vivax

Reference standard test(s) used: Microscopy

Who performed the reference standard tests, and where? Experienced microscopists performed the test, it is not stated where this was done.

If microscopy was used, how many high power fields were looked at? Not stated

How many observers or repeats were used? 2

How were discrepancies between observers resolved? Not stated

Index and comparator tests

Commercial name of the test: BIOTEC Malaria Pv/Pf Rapid Device

Parasite species the test is designed to detect: P. falciparum andP. vivax

Designated type: Other type. HRP-2 for P. falciparum and pLDH for P. vivax.

Batch numbers: Not stated

Transport and storage conditions: Not reported

Who performed the index test, and where? Not reported

Follow-upNot applicable
Notes Source of funding: Not stated
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearCharacteristics of participants not adequately described, although all had symptoms of malaria.
Acceptable reference standard?
All tests		Unclear2 independent microscopists viewed the slides, but the number of fields viewed was not reported.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference tests.
Differential verification avoided?
All tests		YesThe same reference tests were used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference test.
Reference standard results blinded?
All tests		YesReported that the tests were read blindly.
Index test results blinded?
All tests		YesReported that the tests were read blindly.
Uninterpretable results reported?
All tests		NoNumber enrolled in the study was explicitly stated but did not correspond to the number presented in the analysis - 250 patients were enrolled but 276 were included in the analysis.
Withdrawals explained?
All tests		UnclearNumber enrolled in the study was explicitly stated but did not correspond to the number presented in the analysis - 250 patients were enrolled but 276 were included in the analysis.

Selimuzzaman 2010

Clinical features and settings

Presenting signs and symptoms: Fever with oral temperature 100 °F or more or with convincing history of fever

Previous treatments for malaria: "Patients taking anti-malarial drugs for current illness or providing history of anti-malarial therapy within previous four weeks or taking anti-malarial prophylaxis were excluded from the study"

Clinical setting: Sick bay of 37 Rifle Battalion Headquarters

Country: Bangladesh

Malaria endemicity: "Malaria endemic zone"

Malaria endemic species: Not stated

Participants

Sample size: 271

Age: Ranged from 18 years to 57 years

Sex: Male

Co-morbidities or pregnancy: Not mentioned either as an inclusion criteria or a characteristic of participants

Study design

Were participants consecutively enrolled in the study?: Yes
Were they enrolled prospectively?: Yes

If the study evaluated more than one RDT, how were tests allocated to individuals, or did each individual receive all the tests?

1 RDT was evaluated

Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax malaria

Reference standard test(s) used: Microscopy thick and thin blood films

Who performed the reference standard tests, and where? Experienced microscopists at Armed Forces Medical College in Dhaka examined the slides.

If microscopy was used, how many high power fields were looked at? 200

How many observers or repeats were used? 1

How were discrepancies between observers resolved? Only 1 microscopist read each slide

Index and comparator tests

Commercial name of the test: MALARIGEN MALARIA Pf/Pv Antigen Rapid Test (Biotest Diagnostic Corp., Denville, NJ, USA)

Parasite species the test is designed to detect: P. falciparum, P. vivax malaria

Designated type: Unclear, HRP-2 antigen of P. falciparum and unspecified monoclonal antibodies for detection of non-falciparum malarial parasites.

Batch numbers: Not stated

Transport and storage conditions: Not stated

Who performed the index test, and where? Experienced microscopists at Armed Forces Medical College in Dhaka examined the RDT kits.

Follow-upNot applicable
Notes Source of funding: Not stated
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesParticipants were a consecutive series of patients with clinical signs and symptoms of malaria.
Acceptable reference standard?
All tests		NoOne microscopist read each slide.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference tests.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standards.
Reference standard results blinded?
All tests		UnclearDescribed as a single blinded study, but no further details reported.
Index test results blinded?
All tests		UnclearDescribed as a single blinded study, but no further details reported.
Uninterpretable results reported?
All tests		Yes"Three out of 271 (1.11%) cases did not demonstrate control band or become positive only after a long time lag and were excluded from the study. Thin blood films of 6 patients (2.21%) were marked by the microscopist as poor quality and were excluded from the study."
Withdrawals explained?
All tests		YesThe number of participants enrolled in the study is clearly stated and corresponds to the number presented in the analysis minus the number reported to have invalid test results or incomplete data.

Sharew 2009

Clinical features and settings

Presenting signs and symptoms: Febrile patients, clinically suspected for malaria

Previous treatment for malaria: No exclusions based on previous treatment. Information on previous treatment collected, but actual data not provided.

Clinical setting: Outpatient departments of 2 health centres

Country: Ethiopia (Southern - Wondo Genet)

Malaria endemicity: Takes place throughout the year

Malaria endemic species: P. falciparum and P. vivax

Participants

Sample size: 668

Age: All age groups eligible. Actual age range 6 months to 75 years.

Sex: 361 (54%) males, 307 (46%) females

Co-morbidities and pregnancy: No exclusion criteria based on co-morbidities or pregnancy. No details of the frequency of these conditions in the participant population is presented.

Parasite density of microscopy positive cases: Not presented

Study designEnrolment was consecutive and prospective. 2 different RDTs were evaluated, and each participant received both tests.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy thick and thin blood films

Who performed the reference standard tests, and where? Experienced malaria technicians. The microscopy setting was not stated, but in the Wondo Genet area

If microscopy was used, how many high power fields were looked at? 100

How many observers or repeats were used? 2 independent technicians, also checked by the team leader

How were discrepancies between observers resolved? All discordant results between microscopy and RDTs were repeated.

Index and comparator tests

Commerical name of RDT:

  • Paracheck Pf (Orchid Biomedical Systems, Goa, India)

  • CareStart Malaria Pf/Pv Combo test (Access Bio INc, New Jersey, USA)

Parasite(s) designed to detect: P. falciparum

  • Paracheck Pf - P. falciparum

  • CareStart Malaria Pf/Pv Combo test - P. falciparum, P. vivax or mixed infection

Designated type:

  • Paracheck Pf - Type 1

  • CareStart Malaria Pf/Pv Combo test - Type 5

Batch numbers: Not stated

Transport and storage conditions: As per the instructions of the manufacturer

Person(s) performing RDT: Not stated

RDT setting: 2 health centres

Follow-upNot applicable
Notes Source of funding: School of Graduate Studies of the Addis Adaba University through the Graduate Programme in Tropical and Infectious Diseases, Aklilu Lemma Institute of Pathobiology and from the Federal Ministry of Health of Ethiopia. Federal Ministry of Health of Ethiopia and Access Bio Inc donated the test kits.
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesParticipants were a consecutive sample of febrile patients attending health centres with suspected malaria.
Acceptable reference standard?
All tests		Yes2 experienced microscopists independently viewed 100 high power fields before declaring a slide negative.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		UnclearNot described.
Index test results blinded?
All tests		YesStrict blinding with the results available before microscopy reported.
Uninterpretable results reported?
All tests		YesIf a test was un-interpretable then it was repeated.
Withdrawals explained?
All tests		YesThe number of participants enrolled in the study was clearly stated and corresponds to the number included in the analysis; therefore there were no withdrawals.

Singh 2000a

Clinical features and settings

Presenting signs and symptoms: Fever suspected to be malaria

Previous treatment for malaria: There were no exclusions based on previous treatment, and no information presented; this was an outbreak in a rural area

Clinical setting: Mobile field laboratory

Country: India (forest villages in Chhindwara, central India)

Malaria endemicity: Outbreak situation

Malaria endemic species: P. falciparum and P. vivax

Participants

Sample size: 344

Age: All age groups eligible. Actual age range 6 months to 65 years

Sex: Both males and females eligible. Actual proportions of males and females in the participant population not stated

Co-morbidities and pregnancy: No exclusion criteria based on co-morbidities or pregnancy. No details of the frequency of these conditions in the participant population is presented.

Parasite density of microscopy positive cases: Not presented

Study designEnrolment was consecutive and prospective. 1 RDT was evaluated.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy thick blood film

Who performed the reference standard tests, and where? Experienced microscopist for all slides; expert microscopist for re-examined slides. Setting was a mobile field laboratory for all slides; Malaria Research Centre at Jabalur for re-examined slides

If microscopy was used, how many high power fields were looked at? Not stated. However, 200 white blood cells were counted as an alternative indicator; or 500 WBCs for slides that were re-examined

How many observers or repeats were used? 1, but negative blood smears were re-examined if the patient was having severe symptoms, the corresponding RDT result was positive or if P. vivax was diagnosed

How were discrepancies between observers resolved? Not described, most likely accepted the findings of second microscopist

Index and comparator tests

Commerical name of RDT: ICT Malaria Pf/Pv (AMRAD, Australia)

Parasite(s) designed to detect: P. falciparum or mixed infection, non-falciparum species only

Designated type: Type 2

Batch numbers: Not stated

Transport and storage conditions: Not described

Person(s) performing RDT: Field laboratory assistants

RDT setting: Mobile field laboratory

Follow-upNot applicable
Notes Source of funding: Becton Dickinson provided financial support and supplied the RDTs free of charge
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesAll participants were attending an ambulatory setting with fever suspected to be malaria, and enrolment was consecutive.
Acceptable reference standard?
All tests		NoMicroscopy was undertaken by 1 microscopist only; and the number of high power fields viewed was unclear (200 white blood cells).
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		Yes"Blood films were examined...without reference to the results of ICT".
Index test results blinded?
All tests		Yes"All specimens were tested...who were blinded to the results of the blood smear tests".
Uninterpretable results reported?
All tests		UnclearThe numbers of participants originally enrolled in the study was clearly stated and the numbers presented in the analysis correspond; therefore there were no exclusions due to uninterpretable test results.
Withdrawals explained?
All tests		YesThe numbers of participants originally enrolled in the study was clearly stated and the numbers presented in the analysis correspond; therefore there were no withdrawals.

Singh 2003

Clinical features and settings

Presenting signs and symptoms: Fever or history of fever

Previous treatment for malaria: No explicit exclusions based on previous treatment, and no data reported

Clinical setting: Hospital malaria clinic

Country: India, Jabalpur

Malaria endemicity: Not stated

Malaria endemic species: P. falciparum and P. vivax in roughly equal proportions

Participants

Sample size: 80

Age: All age groups eligible. Adults and children included; mean age 27.7 (SD 16.42) for males and 29 (SD 12.8) for females

Sex: Both males and females eligible; included 28 males and 18 females

Co-morbidities and pregnancy: No explicit exclusion criteria based on co-morbidities or pregnancy. No details of the frequency of these conditions in the participant population is presented.

Parasite density of microscopy positive cases: Range 40 to 370,574 parasites per µL for P. falciparum and 318 to 9970 for P. vivax

Study designEnrolment was prospective. The sampling method was not described. Only 1 RDT was evaluated.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy thick blood films

Who performed the reference standard tests, and where? Not stated. Setting was a hospital laboratory

If microscopy was used, how many high power fields were looked at? Not stated

How many observers or repeats were used? If the results of the OptiMAL conflicted with that of microscopy for any sample, the blood smear was re-examined by a different technician

How were discrepancies between observers resolved? If the re-examination of discordant results gave a different result to the first examination, the second results was confirmed by yet another technician

Index and comparator tests

Commerical name of RDT: OptiMAL

Parasite(s) designed to detect: P. falciparum or mixed infection, non-falciparum species only

Designated type: Type 4

Batch numbers: Not stated

Transport and storage conditions: Not described

Person(s) performing RDT: A technician

RDT setting: Hospital clinic or laboratory

Follow-upNot applicable
Notes Source of funding: Not stated.
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearParticipants were all attending a clinic with fever or history of fever, but the sampling method was not described.
Acceptable reference standard?
All tests		UnclearDiscordant results between RDT and microscopy were re-examined; however the number of high power fields viewed before declaring a sample negative was not stated.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		UnclearBlinding not described.
Index test results blinded?
All tests		YesTechnican were blinded to the results of the blood smear examination.
Uninterpretable results reported?
All tests		UnclearThe numbers of participants originally enrolled in the study was clearly stated and the numbers presented in the analysis correspond; therefore there were no exclusions due to uninterpretable test results.
Withdrawals explained?
All tests		YesThe numbers of participants originally enrolled in the study was clearly stated and the numbers presented in the analysis correspond; therefore there were no withdrawals.

Singh 2010

Clinical features and settings

Presenting signs and symptoms: Clinical suspicion of malaria

Previous treatments for malaria: Patients were excluded due to recent anti-malarial intake

Clinical setting: Field clinic

Country: India

Malaria endemicity:

Malaria endemic species: P. falciparum and P. vivax

Participants

Sample size: 409

Age: All ages were included. Mean age was 15 (SD 14).

Sex: Both sexes were included, ratio was not reported.

Co-morbidities or pregnancy: Pregnant women were excluded from participating. Co-morbidities not mentioned either as an inclusion criteria or a characteristic of participants.

Study designEnrolment was prospective and consecutive. 5 RDTs were evaluated; each participant received all the tests.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax

Reference standard test(s) used: Microscopy and PCR

Who performed the reference standard tests, and where? Microscopy was conducted by an experienced microscopist in the laboratory. PCR was also performed in the laboratory, by an independent research assistant.

If microscopy was used, how many high power fields were looked at? 100

How many observers or repeats were used? 1

How were discrepancies between observers resolved? "All negative slides that test positive on the RDT/PCR or all positive slides that test negative on the RDT/PCR were re-examined by another expert technician blinded to the results of microscopy, RDT/PCR and clinical status of the patients."

Index and comparator tests

Commercial name of the test:

  • Parascreen Device (rapid test for malaria Pan/Pf) (Zephyer Biomedicals Goa)

  • Falcivax Device (rapid test for malaria Pv/Pf) (Zephyer Biomedicals Goa)

  • Malascan Device (rapid test for malaria Pf/Pan) (Zephyer Biomedicals Goa),

  • ParaHIT Total (rapid test for Pf & Pan Malaria species) (SPAN Diagnostics Ltd, Surat)

  • First Response Malaria Antigen Combo Card test (pLDH/HRP2) (Premier medical corporation Mumbai)

Parasite species the test is designed to detect:

  • Parascreen - malaria Pan/Pf

  • Falcivax - malaria Pv/Pf

  • Malascan - malaria Pf/Pan

  • ParaHIT Total - Pf & Pan Malaria species

  • First Response Malaria Antigen Combo Card test - pLDH/HRP2

Designated type:

  • Parascreen – Type 3

  • Falcivax – Type 5

  • Malascan – Type 2

  • ParaHIT Total – Type 2

  • First Response Malaria Antigen Combo Card test – Type 3

Batch numbers: Not stated

Transport and storage conditions: "RDTs were stored at 25°C on receipt in the study sites, then allocated to separate groups for storage at 35°C & 45°C for 90 days, at 60°C for 48 hours, and at -10°C for 60 minutes before testing. At the start of the study, the incubators were stabilized at the required temperature for three days before the RDTs to be tested were placed inside. RDTs were removed from storage to reach room temperature for 2 hours before testing and comparisons were made with control RDTs kept at 25°C until use and with microscopy."

Who performed the index test, and where? 2 research assistants tested in the RCTs in field in 10 villages of Satanwada Primary Health Centre.

Follow-upNot applicable
Notes Source of funding: WHO Country Office, New Delhi, India
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesParticipants were a consecutive series of patients attending clinics with clinical signs and symptoms of malaria.
Acceptable reference standard?
All tests		NoOnly 1 microscopist used, except in cases of discordant results between microscopy and RDT.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference tests were used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standards.
Reference standard results blinded?
All tests		YesReported that the tests were read blindly.
Index test results blinded?
All tests		YesReported that the tests were read blindly.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore no withdrawals due to invalid results.
Withdrawals explained?
All tests		Yes37 patients (9%) were excluded as not fulfilling the study enrolment criteria due to recent anti-malarial intake.

Tjitra 1999

Clinical features and settings

Presenting signs and symptoms: Symptomatic with a presumptive clinical diagnosis of malaria: fever or history of fever in the last 24 hours and no other obvious cause of fever

Previous treatment for malaria: Prior use of antimalarials was not an exclusion criteria. Approximately half of the participants reported use of antimalarials within the previous 4 weeks

Clinical setting: Primary health centre

Country: Indonesia (Laratama sub district, West Sumba, East Nusa Tenggara Province, Eastern Indonesia)

Malaria endemicity: Infection rate in children 0 to 9 years of 5.1%

Malaria endemic species: P. falciparum and P. vivax

Participants

Sample size: 560

Age: All ages eligible. Actual age range of the participants 0 to 80 years

Sex: Males and females eligible; 289 males and 271 females included

Co-morbidities: Not mentioned either as an exclusion criteria or a characteristic of the included participants

Parasite density of microscopy positive cases: P. vivax mean 7157 parasites per µL

Study designEnrolment was prospective. The sampling method was not described. 1 RDT was tested.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy thick and thin blood smears

Who performed the reference standard tests, and where? Expert microscopists with over 20 years experience each. The setting was

one local (exact setting not stated); cross-checking was done in Darwin, Australia

If microscopy was used, how many high power fields were looked at? at least 100 for all slides, at least 200 for those cross-checked

How many observers or repeats were used? 1 observer for the majority of slides; discordant results between microscopy and RDT and 20% of slides with concordant results were cross-checked by a 2nd microscopist, blind to the results of 1st microscopy and RDT

How were discrepancies between observers resolved? Not described

Index and comparator tests

Commerical name of RDT: ICT Malaria Pf/Pv

Parasite(s) designed to detect: P. falciparum or mixed infection, non-falciparum species only

Designated type: Type 2

Batch numbers: 100088 for the first 393 tests, and 041388 for the remaining 167 tests

Transport and storage conditions: Not described

Person(s) performing RDT: Performed by trained health workers and read by a study physician blinded to the microscopy results

RDT setting: Primary health centre

Follow-upNot applicable
Notes Source of funding: Financial assistance received from the Northern Territory Government 50th Anniversary of Indonesian Independence Malaria-Tuberculosis Research Fellowships. ICT Pf/Pv kits and some logistical costs were supported by AMRAD-ICT Sydney, New South Wales, Australia
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearParticipants were all attending a primary health care centre with fever and symptoms of malaria, but the sampling method was not described.
Acceptable reference standard?
All tests		YesAll slides were read by an experienced microscopist viewing at least 100 high power fields, and results discordant with RDT were re-examined by another, independent microscopist.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		Yes"The microscopist was unaware of the immunochromatographic test result".
Index test results blinded?
All tests		Yes"The results were read by a study physician who was blinded to the microscopy results".
Uninterpretable results reported?
All tests		UnclearThe number of participants enrolled in the study was clearly stated and correspond to the number presented in the analysis; therefore there were no exclusions due to uninterpretable test results.
Withdrawals explained?
All tests		YesThe number of participants enrolled in the study was clearly stated and corresponded to the number included in the analysis; therefore there were no withdrawals.

Trouvay 2013

Clinical features and settings

Presenting signs and symptoms: Febrile patients who consulted for suspected malaria

Previous treatment for malaria: Not reported on, but there were no exclusion criteria based on antimalarial use

Clinical setting: Not clear

Country: French Guiana

Malaria endemicity: At a low number of focal points on the coast, associated with gold mining

Malaria endemic species: 31% P. falciparum and 68.5% P. vivax. P. malariae cases are occasional.

Participants

Sample size: 960

Age: All ages eligible. Actual age range of the participants 1 to 92 years (median age 25.8 years)

Sex: Males and females eligible; ratio of male to female was 1.2:1

Co-morbidities: Not mentioned either as an exclusion criteria or a characteristic of the included participants

Parasite density of microscopy positive cases: P. vivax mean 0.11%

Study designEnrolment was prospective, with all eligible participants were included. 1 RDT was tested.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy thick and thin blood smears

Who performed the reference standard tests, and where? An expert microscopist at Cayenne Hospital laboratory

If microscopy was used, how many high power fields were looked at? 200 fields in the thin film

How many observers or repeats were used? 1 observer.

How were discrepancies between observers resolved? Not applicable. However, PCR was conducted on samples where microscopy and RDT gave different results

Index and comparator tests

Commerical name of RDT: SD malaria Ag Pf/Pan

Parasite(s) designed to detect: P. falciparum or mixed infection, non-falciparum species only

Designated type: Type 3

Batch numbers: not stated

Transport and storage conditions: Tests were guaranteed to have been stored at the correct temperature (24 to 28C) and were used within their recommended shelf life.

Person(s) performing RDT: Technician

RDT setting: Cayenne Hospital

Follow-upNot applicable
Notes Source of funding: French Ministry of Health
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesAll febrile patients who consulted with suspected malaria during a prospective study were initially included. P. malariae cases were subsequently excluded, however, only 3 of 960 enrolled participants were excluded for this reason.
Acceptable reference standard?
All tests		NoOnly 1 microscopist was used. In case of discordant results between RDT and microscopy, PCR was used to determine infections and species. However, the PCR results were not used to adjust the microscopy results.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		YesThe microscopic examination was carried out simultaneously.
Index test results blinded?
All tests		YesInterpretation of the test was carried out independently of the microscopic examination.
Uninterpretable results reported?
All tests		YesNo invalid RDTs were observed.
Withdrawals explained?
All tests		YesThere were 3 exclusions post-enrolment, due to P. malariae infection.

Valecha 2003

Clinical features and settings

Presenting signs and symptoms: Fever or history of fever

Previous treatment for malaria: Not mentioned, either as an exclusion criteria or a characteristic of included participants

Clinical setting: Malaria clinics and village health workers

Country: India (Delhi, Nadiad, Jabalpur and Sonapur)

Malaria endemicity: 4 sites of different endemicities

Malaria endemic species: P. falciparum and P. vivax

Participants

Sample size: 699

Age: All ages eligible; age range of included participants 1 to 75 years (mean 22.8)

Sex: Included 395 males and 304 females

Co-morbidities: Not mentioned, either as an exclusion criteria or a characteristic of included participants

Parasite density of microscopy positive cases: P. vivax range 40 to 44,000 parasites/µL, median 1020, P. falciparum range 120 to 68,480 parasites/µL, median 2000

Study designEnrolment was prospective. The sampling method was not described. 1 RDT was tested.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy

Who performed the reference standard tests, and where? Microscopist. Setting was not stated

If microscopy was used, how many high power fields were looked at? 100

How many observers or repeats were used? 1 for most slides. All results discordant with RDT results and 20% of concordant results were cross-checked. Negative slides which tested positive by kit were re-examined by counting up to 2000 WBCs.

How were discrepancies between observers resolved? In the case of initially negative slides looked at in more detail because of discordant results, the second reading was taken as true.

Index and comparator tests

Commerical name of RDT: OptiMAL (DiaMed, AG, Cressier, Switzerland)

Parasite(s) designed to detect: P. falciparum or mixed infection, non-falciparum species only

Designated type: Type 4

Batch numbers: 46050.24.05

Transport and storage conditions: Stored below 30°C

Person(s) performing RDT: Not stated

RDT setting: At the study sites (clinic and villages)

Follow-upNot applicable
Notes Source of funding: Not stated
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearAll participants were all attending clinics or approaching village health workers with fever or history of fever, but the sampling method was not described.
Acceptable reference standard?
All tests		UnclearMicroscopists viewed 100 high power fields before declaring a slide negative, and results discordant with RDTs were cross-checked. However, it is not clear whether the person doing the cross-checking was a different microscopist working independently.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		Yes"Microscopists were blinded to the rapid test results".
Index test results blinded?
All tests		YesThe RDT was done before the microscopy.
Uninterpretable results reported?
All tests		NoThe number of participants originally enrolled in the study was not explicitly stated; therefore it is unclear whether there were any exclusions due to uninterpretable test results.
Withdrawals explained?
All tests		UnclearThe number of participants originally enrolled in the study was not explicitly stated; therefore it is unclear whether there were any withdrawals.

van den Broek 2006

Clinical features and settings

Presenting signs and symptoms: New episode of suspected malaria, which could include fever, history or other complaints indicating possible malaria infection

Previous treatment for malaria: Excluded if malaria confirmed (treated or untreated) within the previous 4 weeks

Clinical setting: Malaria outpatient centre

Country: Colombia

Malaria endemicity: Hypoendemic, annual parasite rate 2 to 5%

Malaria endemic species: P. vivax (54%) P. falciparum (46%)

Participants

Sample size: 896

Age: All ages eligible. Actual numbers of children and adults not stated, although the report mentions that many workers were included,

Sex: Both males and females eligible. Most of the participants were male (646, 79%)

Co-morbidities and pregnancy: No exclusions criteria based on co-morbidities. No details of the frequency of these conditions in the participant population is presented.

Parasite density of microscopy positive cases: Geometric mean approximately 2300 parasites per µL for both P. falciparum and P. vivax

Study designEnrolment was prospective. The sampling method was not described. 3 RDTs were tested. All individuals received all 3 tests.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy thick and thin blood smears

Person(s) performing microscopy: Well trained, experienced microscopists

Microscopy setting: Not stated

Number of high power fields examined before declaring negative: At least 200

Number of observer or repeats: 1, except for about one third of the slides (especially low density parasitaemias and mixed infections). In this case, another microscopist viewed the slide and discordant results between microscopists or between slides and RDTs were sent to the University of Antioquia for external cross-checking.

Resolution of discrepancies between observers: Disagreements between the internal and external results were sent to a third laboratory, of the National Health Institute in Bogota. In cases where both external laboratories disagreed with the internal laboratory, results were corrected accordingly.

Index and comparator tests

Commerical name of RDT:

  • Paracheck Pf (Orchid Biomedical Systems, Goa, India)

  • OptiMAL-IT (Diamed AG, Switzerland)

  • NOW Malaria ICT (Binax, Portland, USA)

Parasite(s) designed to detect:

  • Paracheck Pf - P. falciparum

  • OptiMAL-IT - P. falciparum or mixed infection, non-falciparum species only

  • NOW Malaria ICT - P. falciparum or mixed infection, non-falciparum species only

Designated type:

  • Paracheck Pf - Type 1

  • Parascreen - Type 3

  • OptiMAL - Type 4

Batch numbers: Not stated

Transport and storage conditions: Not described

Person(s) performing RDT: A bacteriologist. Where the result was ambiguous, 2 bacteriologists read the test results.

RDT setting: At the malaria centre

Follow-upNot applicable
Notes Source of funding: Medicins Sans Frontières, Holland, and its donors. The American Society of Tropical Medicine and Hygiene assisted with publication expenses.
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearAll participants were patients presenting with suspected malaria, but the sampling method was not described.
Acceptable reference standard?
All tests		NoMicroscopists viewed at least 200 high power fields before declaring a slide negative; however the findings were only verified by a second independent reader for a third of slides.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		YesReport states that microscopists were blinded to the results of RDTs.
Index test results blinded?
All tests		YesReport states that RDTs were blinded to the results of microscopy.
Uninterpretable results reported?
All tests		YesThere were no uninterpretable results; and weak lines were scored as positive.
Withdrawals explained?
All tests		UnclearThe number of participants originally enrolled in the study was not explicitly stated; therefore it was not possible to assess whether there were any withdrawals.

Wongsrichanalai 2003

Clinical features and settings

Presenting signs and symptoms: Oral temperature over 38°C, headache or a history of fever in the previous 72 hours

Previous treatment for malaria: No exclusions based on previous episodes or treatment for malaria; no data presented on recent antimalarial use in the children

Clinical setting: Malaria clinics

Country: Thailand (Maesod)

Malaria endemicity: Not stated

Malaria endemic species: P. falciparum andP. vivax.

Participants

Sample size: 246

Age: Inclusion criteria stipulated over 20 years old

Sex: Both males and females were eligible

Co-morbidities and pregnancy: Not mentioned, either as an exclusion criteria or characteristic of the included participants

Parasite density of microscopy positive cases: Not presented

Study designEnrolment was prospective. The sampling method was not described. 1 RDT was tested.
Target condition and reference standard(s)

Target condition: Malaria parasitaemia

Reference standard: Microscopy thick and thin blood smears

Who performed the reference standard tests, and where? Experienced microscopists at the

Armed Forces Research Institute of Medical Sciences

If microscopy was used, how many high power fields were looked at? 200

How many observers or repeats were used? 2 independent observers, blinded to each others findings

How were discrepancies between observers resolved? Resolved by a third expert microscopist, whose reading was accepted as final. Where there was species discrepancy between microscopy and NOW ICT, PCR was done.

Index and comparator tests

Commerical name of RDT: NOW ICT Malaria Pf/Pv

Parasite(s) designed to detect: P. falciparum or mixed infection, non-falciparum species only

Designated type: Type 2

Batch numbers: 030611

Transport and storage conditions: Not described

Person(s) performing RDT: Technician

RDT setting: Armed Forces Research Institute of Medical Sciences

Follow-upNot applicable
Notes Source of funding: US Army Medical Material Development Activity
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearAll participants were attending malaria clinics with temperature over 38°C, headache or a history of fever in the previous 72 hours, but the sampling method was not adequately described.
Acceptable reference standard?
All tests		Yes2 independent microscopists at a research laboratory viewed at least 200 high power fields before declaring a slide negative.
Partial verification avoided?
All tests		YesAll participants who received the index test also received the reference test.
Differential verification avoided?
All tests		YesThe same reference test was used regardless of the index test results.
Incorporation avoided?
All tests		YesThe index test does not form part of the reference standard.
Reference standard results blinded?
All tests		Yes"read by two microscopists blinded to...the NOW ICT results".
Index test results blinded?
All tests		YesThe RDT was carried out before microscopy.
Uninterpretable results reported?
All tests		YesThe RDTs had to be repeated in 39 of 285 assays. A successful test was eventually completed for each sample.
Withdrawals explained?
All tests		YesThe number of participants enrolled in the study was clearly stated and corresponded with the number included in the analysis, indicating no withdrawals.

Xiaodong 2013

Clinical features and settings

Presenting signs and symptoms: Suspected malaria

Previous treatments for malaria: Not reported.

Clinical setting: TengChong CDC, China and Health Unlimited clinic in Myanmar (China-Myanmar border).

Country: China, Myanmar

Malaria endemicity: Endemic

Malaria endemic species: P. falciparum,P. vivax

Participants

Sample size: 241

Age: Mean 29.62 (11.21), range 3 to 58 years

Sex: 78.01% male, 21.99% female

Co-morbidities or pregnancy: Not reported

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. The study evaluated 1 RDT.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: P. falciparum and P. vivax

Reference standard test(s) used: Microscopy (thick and thin blood smears) corrected by PCR assays.

Who performed the reference standard tests, and where? The microscopic evaluation was done by experienced microscopists. Place not reported. Not reported for PCR.

If microscopy was used, how many high power fields were looked at? 100 fields

How many observers or repeats were used? 2 independent microscopists. Also, a double-blind cross reading of a random 50 blood slides was performed by a senior microscopist.

How were discrepancies between observers resolved?

In the case of discordant results between microscopy and PCR, the results of PCR were used as the standard method.

Index and comparator tests

Commercial name of the test: CareStart malaria HRP2/pLDH (Pf/pan) combo test

Parasite species the test is designed to detect: Multi species

Designated type: Type 3

Batch numbers: C201R

Transport and storage conditions: Not reported.

Who performed the index test, and where? 3 health worker-observers. Place not reported.

Follow-upNot applicable
Notes Source of funding:  Source of funding not reported. CDC (Chinese Center for Disease Control and Prevention).  It is stated that individual biodata and malaria history in the previous 1 year were documented from each suspected case. However, co-morbidities and treatment history have not been reported.  Index test was performed by 3 health worker-observers: the first observer performed readings at 20 minutes (recommended by the manufacturer) and  the other 2 observers, within the next 10 minutes.
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		YesConsecutive patients with suspected malaria were enrolled. Then all patients who were positive for malaria by microscopy and a random sample of negative samples were included in the analysis.
Acceptable reference standard?
All tests		YesMicroscopy was undertaken by 2 independent experienced  microscopists (100 fields) and species identifications was conformed PCR assays.
Partial verification avoided?
All tests		YesAll participants receiving the index tests had their diagnosis verified by reference standard.
Differential verification avoided?
All tests		YesMicroscopy was used as a reference standard for all samples, regardless of index test.
Incorporation avoided?
All tests		YesMicroscopy and PCR was used.
Reference standard results blinded?
All tests		UnclearBlinding of microscopists not reported.
Index test results blinded?
All tests		YesThe 3 observers were blinded to each other's readings and to the results of microscopy and PCR assay.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results. In case the index test result was considered invalid, the test was repeated.
Withdrawals explained?
All tests		YesNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals

Yan 2013

Clinical features and settings

Presenting signs and symptoms: Suspected uncomplicated malaria, fever with axillary temperature above 37.5°C at the time of examination.

Previous treatments for malaria: Not reported

Clinical setting: Local malaria clinics and hospitals at the Laiza township.

Country: Myanmar (China-Myanmar border)

Malaria endemicity: Endemic. Seasonal; mostly in the rainy season from April to November.

Malaria endemic species:

Predominantly P. falciparum and P. vivax

Participants

Sample size: 606

Age: Median 20.3 years, range 6 months to 88 years.

Sex: ˜ 50% male 50% female

Co-morbidities or pregnancy: Not reported

Study designParticipants prospectively enrolled, not reported whether participants consecutively enrolled. All 606 samples were evaluated microscopically and by One Step Malaria Pf/Pan test. A subset of 350 were also evaluated by Malaria Pv/Pf test device.
Target condition and reference standard(s)

Type(s) of malaria parasite tested for: Multiple species; falciparum and non-falciparum.

Reference standard test(s) used: Microscopy thick and thin blood smears and PCR

Who performed the reference standard tests, and where? The reference standard was performed by experienced microscopists. Location not reported. Not reported for PCR.

If microscopy was used, how many high power fields were looked at? 100 fields

How many observers or repeats were used? 2 independent microscopists

How were discrepancies between observers resolved? The results were combined

Index and comparator tests

Commercial name of the test:

  • One Step Malaria Pf/Pan test (Wondfo, China)

  • Malaria Pv/Pf test device (Tycolpharm Co., Limited, UK)

Parasite species the test is designed to detect:

  • One Step Malaria Pf/Pan test: P. falciparum and all human Plasmodium species

  • Malaria Pv/Pf test device: P. falciparum and P. vivax

Designated type:

  • One Step Malaria Pf/Pan test: Type 3

  • Malaria Pv/Pf test device: HRP-2 antigen for P. falciparum and pLDH antigen for P. vivax

Batch numbers: Not reported

Transport and storage conditions: Not reported

Who performed the index test and where? Not reported.

Follow-upNot applicable
Notes Source of funding: The National Institute of Allergy and Infectious Diseases, National Institutes of Health (U19 AI089672).
Table of Methodological Quality
ItemAuthors' judgementDescription
Representative spectrum?
All tests		UnclearPatients with suspected malaria, having fever with axillary temperature above 37.5°C were included in the study. Sampling method was not reported, only a subsample received Pf/Pv test and sampling method for this not described.
Acceptable reference standard?
All tests		YesMicroscopy was performed by 2 independent microscopists. 100 fields. PCR was also done.
Partial verification avoided?
All tests		YesAll participants receiving the index tests had their diagnosis verified by the reference test
Differential verification avoided?
All tests		YesThe same reference test was used.
Incorporation avoided?
All tests		YesThe reference test was microscopy and PCR.
Reference standard results blinded?
All tests		YesThe microscopists were blinded to the results of additional diagnostic tests.
Index test results blinded?
All tests		YesThe readers of RDTs were blinded to the results of microscopy and PCR.
Uninterpretable results reported?
All tests		UnclearNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals due to invalid results.
Withdrawals explained?
All tests		YesNumber enrolled in the study was explicitly stated and corresponded to the number presented in the analysis; therefore there were no withdrawals.

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
A-Elgayoum 2009Not a study of RDTs (compared usual with expert microscopy).
Abeku 2008No data presented on non-falciparum malaria.
Abul Faiz 2000Participants had cerebral malaria.
Ademowo 2012 P. falciparum malaria only.
Adesanmi 2011 P. falciparum malaria only.
Afzaal 2001Review or narrative.
Ahmad 2003Report does not contain enough information to assess eligibility.
Ahmed 2010Case-control study.
Albertini 2012Not a DTA study.
Allen 2011 P. falciparum malaria only.
Anonymous 2005Review or narrative.
Ansah 2008Report does not contain enough information to assess eligibility.
Ansah 2010 P. falciparum malaria only.
Araz 2000Some participants did not have symptoms of malaria.
Arcanjo 2007Non-English language.
Ardic 2012Non-English language.
Arora 2003Participants have severe or complicated malaria.
Arróspide 2004aMost participants had no symptoms of malaria.
Arróspide 2004bNon-English language.
Arróspide 2006 
Ashley 2009Not able to extract or calculate absolute numbers of true positives, false positives, false negatives and true negatives.
Aslan 2001Participants were hospital inpatients.
Assal 1999Not immunochromatographic RDTs.
Avila 2002Participants were travellers returning from an endemic to a non-endemic region.
Ayeh-Kumi 2011 P. falciparum malaria only.
Azazy 2004Only participants with malaria positive blood films by microscopy received the RDT.
Azikiwe 2012 P. falciparum malaria only.
Babacar 2008Not a DTA study.
Baiden 2012 P. falciparum malaria only.
Baltzell 2013Not a DTA study.
Banchongaksorn 1996No data presented on non-falciparum malaria.
Banchongaksorn 1997No data presented on non-falciparum malaria.
Barber 2013Only participants with malaria positive blood films by microscopy were included.
Bartoloni 1998Single case study.
Bassene 2009Not a DTA study.
Bassett 1991Not a DTA study.
Batwala 2011 P. falciparum malaria only.
Beadle 1994Most participants did not have symptoms of malaria.
Bechem 1999Did not present sufficient data to enable extraction of the numbers of true positives, false positive, true negatives and false positives.
Beg 2005All participants were positive for malaria by microscopy.
Belizario 2005Participants were recruited by active case finding.
Bell 2005Not a consecutive sample: excluded a random sample of participants who were negative for malaria by microscopy.
Bell 2006Review or narrative.
Bellagra 1998Participants were travellers returning from an endemic to a non-endemic area.
Bendezu 2008Unable to extract or calculate absolute numbers of true positives, false positives, false negatives and true negatives.
Berens-Riha 2009Subjects were dead.
Bhandari 2008All participants were positive for malaria by microscopy.
Bhat 2012Recruited from a tertiary care hospital.
Bhatt 1994Review or narrative.
Birku 1999Participants had severe or complicated malaria.
Bisoffi 2009aNot a DTA study.
Bisoffi 2009bReview or narrative.
Bisoffi 2011Not a DTA study.
Biswas 2004Not a DTA study.
Biswas 2006Not an immunochromatographic test.
Bjorkman 2011Report does not contain enough information to assess eligibility.
Bojang 1999No data presented on non-falciparum malaria.
Bouchaud 2000Participants were travellers returning from endemic to non-endemic areas.
Bouyou Akotet 2013Unable to extract raw data.
Brenier-Pinchart 2000Participants were travellers returning from endemic to non-endemic areas.
Bruxvoort 2008Participants were recruited by active case finding.
Bualombai 2003No data presented on non-falciparum malaria.
Bualombai 2008Report does not contain enough information to assess eligibility.
Buchachart 2004Participants are hospital in-patients.
Buhalata 2011 P. falciparum malaria only.
Bujanover 2002Not a DTA study.
Cabezas 2004Not a DTA study (comparing 'field' and laboratory RDT results).
Caraballo 1996No data presented on non-falciparum malaria.
Carmona Fonseca 2010Non-English language.
Cavallo 1997Participants were travellers returning from endemic to non-endemic countries.
Chaijaroenkul 2011Included participants without symptoms of malaria.
Chatterjee 2008Report did not contain enough information to assess eligibility.
Cheng 2006Review or narrative.
Chilton 2006Not a DTA study.
Chinkhumba 2010 P. falciparum malaria only.
Chinkhumba 2012 P. falciparum malaria only.
Chiodini 1998Review or narrative.
Chiodini 2005Not a DTA study.
Chitkara 2004No data presented on non-falciparum malaria.
Cho 2001Not undertaken in a malaria endemic area.
Cho 2011Case-control study in travellers returning from an endemic to a non-endemic area.
Cnops 2011Samples not collected in a malaria endemic area.
Coleman 2002aMost participants did not have symptoms of malaria.
Coleman 2002bMost participants did not have symptoms of malaria.
Cong le 2002Non-English language.
Cooke 1999No data presented on non-falciparum malaria.
Craig 1997Tested blood films with artificially cultured and diluted malaria parasites.
Craig 2002The participants were positive for malaria by microscopy.
Cropley 2000Participants were travellers returning from endemic to non-endemic areas.
Cuadros 2007Participants were travellers returning from endemic to non-endemic areas.
Davoodian 2011Not enough information presented to judge eligibility.
Dawoud 2008No data presented on non-falciparum malaria.
de Carsalade 2009Non-English language.
de Dominguez 1996Not a DTA study.
De Monbrison 2004Participants were travellers returning from endemic to non-endemic areas.
de Oliveira 2007No data presented on non-falciparum malaria.
Delaunay 2008Review or narrative.
Deletoille 1987Not commercially available RDTs.
Devi 2002No data presented on non-falciparum malaria.
Di Perry 1997All participants were positive for malaria by microscopy.
Di Santi 2011Positive and negative blood samples selected for the study.
Diarra 2012Unable to extract or calculate absolute numbers of true positives, false positives, false negatives and true negatives for individual malaria species.
Dietze 1995Some participants did not have symptoms of malaria.
Drakeley 2009Review or narrative.
Dubarry 1990Not evaluating an immunochromatographic RDT.
Durand 2005Review or narrative.
Durand 2007Participants were travellers returning from endemic to non-endemic areas.
Durrheim 1998No data presented on non-falciparum malaria.
Dyer 2000All participants were positive for malaria by microscopy.
Dzakah 2013Positive and negative blood samples selected for the study.
Eisen 2000Not undertaken in a malaria endemic area.
El-Moamly 2007Participants were travellers returning from a malaria endemic to a non endemic area.
Elmardi 2009Not a DTA study.
Endeshaw 2008Most participants did not have symptoms of malaria.
Endeshaw 2010Unable to extract raw data for 2 x 2 table.
Existe 2010Not enough information presented to judge eligibility.
Falade 2013 P. falciparum malaria only.
Fan 2000Non-English language.
Fancony 2013Included assymptomatic individuals (population survey).
Farcas 2003Participants were travellers returning from endemic to non-endemic areas.
Farcas 2004Not an immunochromatographic test.
Ferro 2002Participants were travellers returning from an endemic area to an non-endemic area.
Figueiredo Filho 2003All participants were positive for malaria by microscopy.
Fogg 2008No data presented on non-falciparum malaria.
Forney 2001No data presented on non-falciparum malaria.
Forney 2003No data presented on non-falciparum malaria.
Fryauff 1997Report did not contain enough information to assess eligibility.
Fryauff 2000Participants did not have symptoms of malaria.
Funk 1999Participants were travellers returning from endemic to non-endemic areas.
Garavelli 2002Participants were travellers returning from endemic to non-endemic areas.
Garcia 1996Report did not contain enough information to assess eligibility.
Gatti 2002Participants were travellers returning from endemic to non-endemic areas.
Gatti 2007Participants were travellers returning from endemic to non-endemic areas.
Gaye 1998No data presented on non-falciparum malaria.
Gaye 1999No data presented on non-falciparum malaria.
Gelaglie 2010Not enough information presented to judge eligibility.
Gerstl 2009No data presented on non-falciparum malaria.
Ghanchi 2009Not a DTA study.
Ghosh 2000No data presented on non-falciparum malaria.
Ghouth 2012 P. falciparum malaria only.
Gillet 2009aParticipants were travellers returning from endemic to non-endemic areas.
Gillet 2009bNot a DTA study.
Gillet 2009cParticipants were travellers returning from an endemic to a non-endemic area.
Gillet 2011Not a DTA study: patients negative by reference standard standard were excluded.
Gogtay 1999Participants had severe or complicated malaria.
Gogtay 2003Participants were all positive for malaria by blood smear.
Goh 2013Does not evaluate an RDT.
Gomes 2013Selected positve and negative samples by reference test.
Gonzáles-Cerón 2005Non-English language.
Grobusch 1999Not undertaken in a malaria endemic area.
Grobusch 2002Not undertaken in a malaria endemic area.
Grobusch 2003aParticipants were travellers returning from endemic to non-endemic areas.
Grobusch 2003bParticipants were travellers returning from endemic to non-endemic areas.
Gupta 2001Some participants had severe or complicated malaria.
Guthmann 2002No data presented on non-falciparum malaria.
Gutierrez 2005Not a DTA study.
Hada 2011Unable to extract or calculate absolute numbers of true positives, false positives, false negatives and true negatives for individual malaria species.
Haditsch 2004Review or narrative.
Hance 2005Review or narrative.
Happi 2004All participants were positive for malaria by microscopy.
Harchut 2013 P. falciparum malaria only.
Hashizume 2006Participants were displaced people from mainly very low endemicity areas.
Hawkes 2009Not a DTA study.
Hernandes 2001Participants were travellers returning from endemic to non-endemic areas.
Holmberg 1992Not a DTA study.
Hopkins 2007No data presented on non-falciparum malaria.
Hopkins 2008No data presented on non-falciparum malaria.
Hossain 2008Participants had severe or complicated malaria.
Houmsou 2011Report does not contain enough information to assess eligibility.
Houzé 2009All participants were positive for malaria by microscopy.
Houzé 2011Participants were travellers returning from endemic to non-endemic areas.
Humar 1997Participants were travellers returning from endemic to non-endemic areas.
Huong 2002Not based on a consecutive sample; included a group malaria positive by microscopy and an asymptomatic malaria negative control group.
Hänscheid 1999Review or narrative.
Iqbal 2000Not a consecutive sample: participants were selected to have a high risk of rheumatoid factor.
Iqbal 2001Participants were travellers returning from endemic to non-endemic areas.
Iqbal 2002Participants were travellers returning from endemic to non-endemic areas.
Iqbal 2003No data presented on non-falciparum malaria.
Iqbal 2004All participants were positive for malaria by microscopy.
Ishengoma 2011 P. falciparum malaria only.
Jang 2013Participants were travellers returning from endemic to non-endemic areas.
Jelinek 1996Does not evaluate an immunochromatographic RDT for malaria.
Jelinek 1999Participants were travellers returning from endemic to non-endemic areas.
Jelinek 2000Participants were travellers returning from endemic to non-endemic areas.
Jelinek 2001Participants were travellers returning from endemic to non-endemic areas.
Jeurissen 1999Review or narrative.
John 1998All participants were positive for malaria by microscopy.
Joshi 2004Not evaluating an immunochromatographic RDT.
Kaewsonthi 1996Not a DTA study.
Kahama-Maro 2008Report does not contain enough information to assess eligibility.
Kahama-Maro 2011No data presented on non-falciparum malaria.
Kakkilaya 2003Review or narrative.
Kamugisha 2008Most participants did not have symptoms of malaria.
Kar 1998No data presented on non-falciparum malaria.
Karbwang 1996All participants were positive for malaria by microscopy.
Karimov 2011Non-English language.
Kashif 2013 P. falciparum malaria only.
Katakai 2011Positive and negative blood samples selected for the study.
Kattenberg 2011Not enough information presented to judge eligibility.
Kaur 2000All participants had cerebral malaria.
Kaushal 1995Tested for P. knowlesi infection in monkeys.
Kaushal 1997Review or narrative.
Kawai 2009Tested for P. knowlesi infection in monkeys.
Keating 2009Most participants did not have symptoms of malaria.
Khairnar 2009Participants were travellers returning from an endemic to a non-endemic area.
Khan 2004Participants were hospital inpatients.
Kilian 1997Unable to extract or calculate absolute numbers of true positives, false positives, false negatives and true negatives.
Kilian 1999No data presented on non-falciparum malaria.
Kim 2008Includes a symptomatic group with malaria infection identified by microscopy, and an asymptomatic group with no malaria infection by microscopy.
Kim 2011Only participants with malaria positive blood films by microscopy received the RDT.
Kim 2013Includes a symptomatic group with malaria infection identified by microscopy, and an asymptomatic group with no malaria infection by microscopy.
Knappik 2002Participants were travellers returning from endemic to non-endemic areas.
Kodisinghe 1997Some participants did not have symptoms of malaria.
Koita 2012 P. falciparum malaria only.
Kumar 1996No data presented on non-falciparum malaria.
Kumar 2000Participants were migrants from a very low endemicity area.
Kumar 2004No data presented on non-falciparum malaria.
Kumar 2012Not a DTA study.
Kumar 2013Not a diganostic test accuracy study.
Kweka 2011 P. falciparum malaria only.
Kyabayinze 2008No data presented on non-falciparum malaria.
Labbé 2001No data presented on non-falciparum malaria.
Lee 1999Some participants did not have symptoms of malaria.
Lee 2008Participants were soldiers usually residing in non-endemic areas.
Lee 2011Positive and negative blood samples selected for the study.
Lema 1999Some participants were attending for follow-up of a previously diagnosed and treated case of malaria.
Lepère 2004Not a DTA study.
Lim 2001Half the participants had malaria confirmed by microscopy before enrolment.
Llanos Zavalaga 2000Not a DTA study.
Llanos-Zavalaga 2002Non-English language.
Mahajan 2000Participants were hospital inpatients.
Makler 1998Review or narrative.
Makler 2009Review or narrative.
Malik 2004Study was based at a tertiary referral centre with a high percentage of patients with complicated malaria.
Mankhambo 2002Most participants did not have symptoms of malaria.
Mason 2002Some participants did not have symptoms of malaria.
Mawili-Mboumba 2010 P. falciparum malaria only.
Mayxay 2004Unable to extract or calculate absolute numbers of true positives, false positives, false negatives and true negatives.
Mboera 2006aNo data presented on non-falciparum malaria.
McCutchan 2008Review or narrative.
McMorrow 2010 P. falciparum malaria only.
Meena 2009Participants were all hospital inpatients.
Menan 1996Not a study of malaria RDTs.
Mendiratta 2006No data presented on non-falciparum malaria.
Mendoza 2007Report does not contain enough information to assess eligibility.
Mendoza 2013Report does not contain enough information to assess eligibility.
Mengesha 1999Unable to extract or calculate absolute numbers of true positives, false positives, false negatives and true negatives.
Mens 2007No data presented on non-falciparum malaria.
Mens 2010RDT evaluated is not an immunochromatographic test.
Metzger 2008Participants were recruited by active case finding.
Metzger 2009Not a DTA study.
Mharakurwa 1997aParticipants had all been recently treated for malaria.
Mharakurwa 1997bNo data presented on non-falciparum malaria.
Miantuasila 2012 P. falciparum malaria only.
Mikhail 2011Positive and negative blood samples selected for the study.
Miller 2001Letter.
Miller 2008Unable to extract or calculate absolute numbers of true positives, false positives, false negatives and true negatives.
Mills 1999Participants were travellers returning from endemic to non-endemic areas.
Mills 2007Report does not contain enough information to assess eligibility.
Mills 2010 P. falciparum malaria only.
Mills 2010a P. falciparum malaria only.
Minja 2012Not all participants had symptoms of malaria: prospective cohort of pregnant women.
Minodier 2005Review or narrative.
Mishra 1999Not a consecutive sample; comprised a malaria positive group by microscopy and negative control groups.
Mishra 2007Report did not contain enough information to assess eligibility.
Mohanty 1999Report did not contain enough information to assess eligibility.
Mohapatra 1996No data presented on non-falciparum malaria.
Montoya 2008Non-English language.
Moody 2000Participants were travellers returning from endemic to non-endemic areas.
Moody 2002aReview or narrative.
Moody 2002bRDTs tested on artificially cultured blood samples.
Moonasar 2007Not a DTA study.
Moonasar 2009No data presented on non-falciparum malaria.
Morankar 2011 P. falciparum malaria only.
Moulin 2009Review or narrative.
Msellem 2009No data presented on non-falciparum malaria.
Mtove 2011 P. falciparum malaria only.
Mueller 2007Participants not representative of people presenting to ambulatory care setting with symptoms of malaria.
Muhindo 2012No data presented on non-falciparum malaria.
Munier 2009Report does not contain enough information to assess eligibility.
Murahwa 1999No data presented on non-falciparum malaria.
Murray 2003Review or narrative.
Murray 2008Review or narrative.
Mwanza 2005No data presented on non-falciparum malaria.
Myjak 2004Participants were travellers returning from endemic to non-endemic areas.
Naing 2002aNo data presented on non-falciparum malaria.
Nema 2005All participants were positive for malaria by microscopy.
Neumann 2008Most participants did not have symptoms of malaria.
Nicastri 2009aNo data presented on non-falciparum malaria.
Nigussie 2008No data presented on non-falciparum malaria.
Nkrumah 2010RDT evaluated is not an immunochromatographic test.
Nkrumah 2011 P. falciparum malaria only: Only 2 cases of non-falciparum malaria (263 study participants).
Nour 2011Not enough information presented to extract numbers of true postives, false positives, true negatives and false negatives.
Nwuba 2001No data presented on non-falciparum malaria.
Nyunt 2013Not a DTA study: all participants had positive blood slide for P. falciparum
Ochola 2006Review or narrative.
Omar 1999No data presented on non-falciparum malaria.
OMS 1999Not a DTA study.
Onile 2005Review or narrative.
Osman 2010Less than one percent of the malaria detected was P. vivax.
Ouattara 2011Unable to extract or calculate absolute numbers of true positives, false positives, false negatives and true negatives for individual malaria species (mainly P. falciparum but numbers not provided).
Ozbilge 2006Not an immunochromatographic test.
Pabon 2007Non-English language.
Pakalapati 2013Unable to extract data on numbers of true positives, false positive, true negatives and false negatives.
Palmer 1998Report did not contain enough information to assess eligibility.
Palmer 1999All participants were positive for malaria by microscopy.
Palmer 2003Participants were travellers returning from endemic to non-endemic areas.
Pammenter 1988Review or narrative.
Pandey 1995Review or narrative.
Pandya 2001No data presented on non-falciparum malaria.
Park 2003Not a consecutive sample; included a known malaria group and negative control group by microscopy.
Park 2006Written in Korean only.
Parra 1991Not a DTA study.
Peng 2012 P. falciparum malaria only.
Penhalbel 2005Not a consecutive sample; included a known malaria group and negative control group by microscopy.
Peyron 1999Review or narrative.
Phommanivong 2010Not a DTA study.
Pica 2005Review or narrative.
Pieroni 1998Participants were travellers returning from endemic to non-endemic areas.
Pinto 1999All participants had previous tested negative for malaria and had symptoms that meant complicated malaria could not be ruled out.
Piper 1999Half the participants lived in non-endemic areas.
Pividal 1994Not a DTA study.
Planche 2001Review or narrative.
Playford 2002Participants were travellers returning from endemic to non-endemic areas.
Popov 2000Non-English language.
Popov 2004Non-English language.
Premji 1994Participants did not have symptoms of malaria.
Prou 1988Not an immunochromatographic test.
Proux 2001Majority of participants did not have symptoms of malaria.
Pérez 2007Review or narrative.
Quintana 1998Report did not contain enough information to assess eligibility.
Rabinovich 2006Non-English language.
Radrianasolo 2007Non-English language.
Rahim 2002All participants were positive for malaria by microscopy.
Rajendran 2006Report does not contain enough information to assess eligibility.
Ramutton 2012Participants had severe malaria.
Ratnawati 2008Many participants were recruited by active case finding.
Ratsimbasoa 2012 P. falciparum malaria only.
Rehlis 2004Non-English language.
Reyburn 2007Not a DTA study.
Ricci 2000Participants were travellers returning from endemic to non-endemic areas.
Richardson 2002Participants were travellers returning from endemic to non-endemic areas.
Richter 2004aReview or narrative.
Richter 2004bParticipants were travellers returning from endemic to non-endemic areas.
Rimón 2003No data presented on non-falciparum malaria.
Roche 1995Not an immunochromatographic test.
Rodríguez-Iglesias 2005Review or narrative.
Rodulfo 2007Some of the participants did not have symptoms of malaria.
Rolland 2006Not a DTA study.
Rosenthal 2012Not a DTA study: editorial.
Rubio 2001Participants were travellers returning from endemic to non-endemic areas.
Runsewe-Abiodun 2012Not enough information presented to absolute numbers of true positives, true negatives, false positives and false negatives.
Ryan 2002Not a DTA study.
Samal 1998Not an immunochromatographic test.
Saranya 2003Review or narrative.
Sayang 2009No data presented on non-falciparum malaria.
Schachterle 2011 P. falciparum only.
Schmidt 2003Review or narrative.
Schmidt 2011Only participants with positive P. falciparum malaria slides were included.
Seidahmed 2008Not a DTA study.
Senn 2012Not a diagnostic test accuracy study: blood slide was performed to assess treatment outcome.
Sezibera 2009Not a DTA study.
Shah 2004All participants were positive for malaria by microscopy.
Shaikh 2013Does not differentiate malaria parasitiaemia by species.
Shakya 2012Unable to extract or calculate absolute numbers of true positives, false positives, false negatives and true negatives.
Shamsi 1999Report did not contain enough information to assess eligibility.
Sharma 1999No data presented on non-falciparum malaria.
Sharma 2008Some participants did not have symptoms of malaria.
She 2007Not undertaken in a malaria endemic area.
Shenoi 1996Report did not contain enough information to assess eligibility.
Shiff 1993Some participants did not have symptoms of malaria.
Shillcutt 2008Not a DTA study.
Shirayama 2008Not a DTA study.
Shujatullah 2006Participants had severe or complicated malaria.
Shujatullah 2009Participants were hospital inpatients.
Singer 2004Most participants did not have symptoms of malaria.
Singh 1997aNo data presented on non-falciparum malaria.
Singh 1997bNo data presented on non-falciparum malaria.
Singh 2000bSome participants did not have symptoms of malaria.
Singh 2000cNo data presented on non-falciparum malaria.
Singh 2001Participants were recruited by active case finding.
Singh 2002aMost participants did not have symptoms of malaria.
Singh 2002bAll participants were positive for malaria by microscopy.
Singh 2004aParticipants had severe or complicated malaria.
Singh 2005aMost participants did not have symptoms of malaria.
Singh 2005bUnable to extract or calculate absolute numbers of true positives, false positives, false negatives and true negatives.
Singh 2005cSome participants did not have symptoms of malaria.
Singh 2007Most participants did not have symptoms of malaria.
Singh 2013Participants selected through active case detection.
Skarbinski 2009Not a DTA study.
Smego 2000Review or narrative.
Sotimehin 2007Most participants did not have symptoms of malaria.
Soto Tarazona 2004Unable to extract or calculate absolute numbers of true positives, false positives, false negatives and true negatives.
Srinivasan 2000Participants were travellers returning from endemic to non-endemic areas.
Stauffer 2005Participants were refugees from an endemic to a non-endemic country.
Stauffer 2006Participants were travellers returning from endemic to non-endemic areas.
Stauffer 2009Participants were all travellers returning from an endemic to a non-endemic area.
Stephens 1999No data presented on non-falciparum malaria.
Stow 1999No data presented on non-falciparum malaria.
Strøm 2013No cases of non-falciparum malaria.
Stürenburg 2009Review or narrative.
Surpur 2010Data not presented for P. falciparum and P. vivax separately.
Susi 2005Participants were all travellers returning from an endemic to a non-endemic area.
Swarthout 2007All participants were positive for malaria by microscopy.
Tagbo 2007No data presented on non-falciparum malaria.
Tagbor 2008Most participants did not have symptoms of malaria.
Tahar 2013 P. falciparum malaria only: only 4 cases of non-falciparum malaria (179 participants).
Tarimo 2001Unable to extract or calculate absolute numbers of true positives, false positives, false negatives and true negatives.
Taylor 2002All participants were positive for malaria by microscopy.
Tekeste 2012 P. falciparum malaria only.
Tham 1999Participants were all travellers returning from an endemic to a non-endemic area.
Thepsamarn 1997All participants were positive for malaria by microscopy.
Tietche 1996Not a DTA study.
Tjitra 2001aAll participants were positive for malaria by microscopy.
Tjitra 2001bAll participants were positive for malaria by microscopy.
Trachsler 1999Not a DTA study.
Uguen 1995Participants were travellers returning from endemic to non-endemic areas.
Uneke 2008aReview or narrative.
Uneke 2008bNot a DTA study.
Uzochukwu 2009No data presented on non-falciparum malaria.
Valecha 1998Report does not contain enough information to assess eligibility.
Valecha 2002Participants were recruited by active case finding.
Valéa 2009No data presented on non-falciparum malaria.
Van den Ende 1998Participants were travellers returning from endemic to non-endemic areas.
Van der Palen 2009Participants were travellers returning from endemic to non-endemic areas.
Van Dijk 2009Participants were travellers returning from an endemic to a non-endemic area.
van Hellemond 2009Not a DTA study.
VanderJagt 2005Most participants had no symptoms of malaria.
Venkatesh 2007Participants had severe or complicated malaria.
Verlé 1996No data presented on non-falciparum malaria.
Voller 1993Review or narrative.
Waltz 2007Review or narrative.
Wang J-Y 2007Not a commercial test kit.
Wanji 2008Participants did not have symptoms of malaria.
WHO 1996Review or narrative.
Wiese 2006Participants were travellers returning from endemic to non-endemic areas.
Willcox 2009No data presented on non-falciparum malaria.
Williams 2008Not a DTA study.
Wilson 2013Review or narrative.
Win 2001Review or narrative.
Wolday 2001No data presented on non-falciparum malaria.
Wongsrichanalai 1999No data presented on non-falciparum malaria.
Wongsrichanalai 2001Review or narrative.
Wongsrichanalai 2007Review or narrative.
Woyessa 2013Participants recruited through active case detection (population survey).
Wu 2005Not an immunochromatographic RDT kit.
Yadav 1997No data presented on non-falciparum malaria.
Yadav 2012Not enough information presented to assess eligibility (not clear where participants presented with symptoms).
Yavo 2002No data presented on non-falciparum malaria.
Zakai 2003Review or narrative.
Zerpa 2007Not able to extract or calculate absolute numbers of true positives, false positives, false negatives and true negatives.
Zheng 1999Non-English language.
Zhu 1998Non-English language.
Zikusooka 2008Not a DTA study.
Zurovac 2008Not a DTA study.

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10.1002/14651858.CD011431

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Copyright © 2014 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.

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  • Humans

    • * Indicates the major topics for the study

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Tables

References

References to studies included in this review

Alam 2011 {published data only}
  • Alam MS, Mohon AN, Mustafa S, Khan WA, Islam N, Karim MJ, et al. Real-time PCR assay and rapid diagnostic tests for the diagnosis of clinically suspected malaria patients in Bangladesh. Malaria Journal 2011;10:175.
Andrade 2010 {published data only}
  • Andrade BB, Reis-Filho A, Barros AM, Souza-Neto SM, Nogueira LL, Fukatano KF, et al. Towards a precise test for malaria diagnosis in the Brazilian Amazon: comparison among field microscopy, a rapid diagnostic test, nested PCR, and a computational expert system based on artificial neural networks. Malaria Journal 2010;9:117.
Ashton 2010 {published data only}
  • Ashton RA, Kefyalew T, Tesfaye G, Counihan H, Yadeta D, Cundill B, et al. Performance of three multi-species rapid diagnostic tests for diagnosis of Plasmodium falciparum and Plasmodium vivax malaria in Oromia Regional State, Ethiopia. Malaria Journal 2010;9:297.
Bell 2001a {published data only}
  • Bell D, Go R, Miguel C, Walker J, Cacal L, Saul A. Diagnosis of malaria in a remote area of the Philippines: comparison of techniques and their acceptance by health workers and the community. Bulletin of the World Health Organization 2001;79(10):933-41.
Bell 2001b {published data only}
  • Bell D, Go R, Miguel C, Walker J, Cacal L, Saul A. Diagnosis of malaria in a remote area of the Philippines: comparison of techniques and their acceptance by health workers and the community. Bulletin of the World Health Organization 2001;79(10):933-41.
Bendezu 2010 {published data only}
  • Bendezu J, Rosas A, Grande T, Rodriguez H, Llanos-Cuentas A, Escobedo J, et al. Field evaluation of a rapid diagnostic test (Parascreen) for malaria diagnosis in the Peruvian Amazon. Malaria Journal 2010;9:154.
Bharti 2008 {published data only}
  • Bharti PK, Silawat N, Singh PP, Singh MP, Shukla M, Chand G, et al. The usefulness of a new rapid diagnostic test, the First Response Malaria Combo (pLDH/HRP2) card test, for malaria diagnosis in the forested belt of central India. Malaria Journal 2008;7:126.
Chanie 2011 {published data only}
  • Chanie M, Erko B, Animut A, Legesse M. Performance of CareStartTM Malaria Pf/Pv Combo test for the diagnosis of Plasmodium falciparum and Plasmodium vivax infections in the Afar Region, North East Ethiopia. Ethiopian Journal of Health Development 2011;25(3):206-11.
Chayani 2004 {published data only}
  • Chayani N, Das B, Sur M, Bajoria S. Comparison of parasite lactate dehydrogenase based immunochromatographic antigen detection assay (OptiMAL) with microscopy for detection of malaria parasites. Indian Journal of Medical Microbiology 2004;22(2):104-6.
Dev 2004 {published data only}
  • Dev V. Relative utility of dipsticks for diagnosis of malaria in mesoendemic area for Plasmodium falciparum and P. vivax in Northeastern India. Vector-Borne and Zoonotic Diseases 2004;4(2):123-30.
Eibach 2013 {published data only}
  • Eibach D, Traore B, Bouchrik M, Coulibaly B, Coulibaly N, Siby F, et al. Evaluation of the malaria rapid diagnostic test VIKIA malaria Ag Pf/PanTM in endemic and non-endemic settings. Malaria Journal 2013;12:188.
Elahi 2013 {published data only}
  • Elahi, R, Mohon, A.N, Khan, W.W, Haque, R, Alam, M.S. Performance of a HRP-2/pLDH based rapid diagnostic test at the Bangladesh-India-Myanmar border area for diagnosis of clinical malaria. Malaria Journal 2013;12:378.
Endeshaw 2012a {published data only}
  • Endeshaw T, Graves PM, Ayele B, Mosher AW, Gebre T, Ayalew F, et al. Performance of local light microscopy and the ParaScreen Pan/Pf rapid diagnostic test to detect malaria in health centers in Northwest Ethiopia. PLoS One 2012;7(4):e33014.
Endeshaw 2012b {published data only}
  • Endeshaw T, Graves PM, Ayele B, Mosher AW, Gebre T, Ayalew F, et al. Performance of local light microscopy and the ParaScreen Pan/Pf rapid diagnostic test to detect malaria in health centres in Northwest Ethiopia. PLoS One 2012;7(4):e33014.
Endeshaw 2012c {published data only}
  • Endeshaw T, Graves PM, Ayele B, Mosher AW, Gebre T, Ayalew F, et al. Performance of local light microscopy and the ParaScreen Pan/Pf rapid diagnostic test to detect malaria in health centres in Northwest Ethiopia. PLoS One 2012;7(4):e33014.
Endeshaw 2012d {published data only}
  • Endeshaw T, Graves PM, Ayele B, Mosher AW, Gebre T, Ayalew F, et al. Performance of local light microscopy and the ParaScreen Pan/Pf rapid diagnostic test to detect malaria in health centres in Northwest Ethiopia. PLoS One 2012;7(4):e33014.
Endeshaw 2012e {published data only}
  • Endeshaw T, Graves PM, Ayele B, Mosher AW, Gebre T, Ayalew F, et al. Performance of local light microscopy and the ParaScreen Pan/Pf rapid diagnostic test to detect malaria in health centres in Northwest Ethiopia. PLoS One 2012;7(4):e33014.
Endeshaw 2012f {published data only}
  • Endeshaw T, Graves PM, Ayele B, Mosher AW, Gebre T, Ayalew F, et al. Performance of local light microscopy and the ParaScreen Pan/Pf rapid diagnostic test to detect malaria in health centres in Northwest Ethiopia. PLoS One 2012;7(4):e33014.
Endeshaw 2012g {published data only}
  • Endeshaw T, Graves PM, Ayele B, Mosher AW, Gebre T, Ayalew F, et al. Performance of local light microscopy and the ParaScreen Pan/Pf rapid diagnostic test to detect malaria in health centres in Northwest Ethiopia. PLoS One 2012;7(4):e33014.
Endeshaw 2012h {published data only}
  • Endeshaw T, Graves PM, Ayele B, Mosher AW, Gebre T, Ayalew F, et al. Performance of local light microscopy and the ParaScreen Pan/Pf rapid diagnostic test to detect malaria in health centres in Northwest Ethiopia. PLoS One 2012;7(4):e33014.
Endeshaw 2012i {published data only}
  • Endeshaw T, Graves PM, Ayele B, Mosher AW, Gebre T, Ayalew F, et al. Performance of local light microscopy and the ParaScreen Pan/Pf rapid diagnostic test to detect malaria in health centres in Northwest Ethiopia. PLoS One 2012;7(4):e33014.
Endeshaw 2012j {published data only}
  • Endeshaw T, Graves PM, Ayele B, Mosher AW, Gebre T, Ayalew F, et al. Performance of local light microscopy and the ParaScreen Pan/Pf rapid diagnostic test to detect malaria in health centres in Northwest Ethiopia. PLoS One 2012;7(4):e33014.
Fernando 2004 {published data only}
  • Fernando SD, Karunaweera ND, Fernando WP. Evaluation of a rapid whole blood immunochromatographic assay for the diagnosis of Plasmodium falciparum and Plasmodium vivax malaria. Ceylon Medical Journal 2004;49(1):7-11.
  • Fernando SD, Karunaweera ND, Fernando WP, Attanayake N, Wickremasinghe AR. A cost analysis of the use of the rapid, whole-blood, immunochromatographic Pf/Pv assay for the diagnosis of Plasmodium vivax malaria in rural areas of Sri Lanka. Annals of Tropical Medicine and Parasitology 2004;98(1):5-13.
Harani 2006 {published data only}
  • Harani MS, Beg MA, Khaleeq L, Adil SN, Kakepoto GN, Khurshid M. Role of ICT Malaria immunochromatographic test for rapid diagnosis of malaria. Journal of the Pakistan Medical Association 2006;56(4):167-71.
Kolaczinski 2004 {published data only}
  • Klolaczinski J, Mohammed N, Ali A, Ali M, Khan N, Ezard N, Rowland M. Comparison of the OptiMAL rapid antigen test with field microscopy for the detection of Plasmodium vivax and P. falciparum: considerations for the application of the rapid test in Afghanistan. Annals of Tropical Medicine and Parasitology 2004;98(1):15-20.
Kosack 2013 {published data only}
  • Kosack CS, Naing WT, Piriou E, Shanks L. Routine parallel diagnosis of malaria using microscopy and the malaria rapid diagnostic test SD 05FK60: the experience of Médecins Sans Frontières in Myanmar. Malaria Journal 2013;12:167.
Mekonnen 2010 {published data only}
  • Mekonnen Z, Ali S, Belay G, Suleman S, Chatterjee S. Evaluation of the performance of Carestart Malaria Pf/Pf Combo rapid diagnostic test for the diagnosis of malaria in Jimma, southwestern Ethiopia. Acta Tropica 2010;113(3):285-8.
Metzger 2011 {published data only}
  • Metzger WG, Vivas-Martínez S, Giron A, Vaccari E, Campos E, Rodríguez I, et al. Assessment of routine malaria diagnosis in the Venezuelan Amazon. Transactions of the Royal Society of Tropical Medicine and Hygiene 2011;105(5):262-8.
Moges 2012 {published data only}
  • Moges B, Amare B, Belyhun Y, Tekeste Z, Gizachew M, Workineh M, et al. Comparison of CareStart HRP2/pLDH COMBO rapid malaria test with light microscopy in north-west Ethiopia. Malaria journal 2012;11:234.
Mohon 2012 {published data only}
  • Mohon AN, Elahi R, Podder MP, Mohiuddin K, Hossain MS, Khan WA, et al. Evaluation of the OnSite (Pf/Pan) rapid diagnostic test for diagnosis of clinical malaria. Malaria Journal 2012;11:415.
Pattanasin 2003 {published data only}
  • Pattanasin S, Proux S, Chompasuk D, Luwiradaj K, Jacquier P, Looareesuwan S, et al. Evaluation of a new plasmodium lactate dehydrogenase assay (OptiMAL-IT) for the detection of malaria. Transactions of the Royal Society of Tropical Medicine and Hygiene 2003;97(6):672-4.
Rakotonirina 2008 {published data only}
  • Rakotonirina H, Barnadas C, Raherijafy R, Andrianantenaina H, Ratsimbasoa A, Randrianasolo L, et al. Accuracy and reliability of malaria diagnostic techniques for guiding febrile outpatient treatment in malaria-endemic countries. American Journal of Tropical Medicine and Hygiene 2008;78(2):217-21.
Ratsimbasoa 2007 {published data only}
  • Ratsimbasoa A, Randriamanantena A, Raherinjafy R, Rasoarilalao N, Ménard D. Which malaria rapid test for Madagascar? Field and laboratory evaluation of three test and expert microscopy of samples from suspected malaria patients in Madagascar. American Journal Of Tropical Medicine and Hygiene 2007;76(3):481-5.
Ratsimbasoa 2008 {published data only}
  • Ratsimbasoa A, Fanazava L, Radrianjafy R, Ramilijaona J, Rafanomezantsoa H, Ménard D. Short report: Evaluation of two new immunochromatographic assays for diagnosis of malaria. American Journal of Tropical Medicine and Hygiene 2008;79(5):670-2.
Samane 2010 {published data only}
  • Samane AK, Nahid HZ, Saaed S, Khazen H, Ali H, Ahmad R, et al. Comparison of microscopy and RDTs techniques for laboratory detection of malaria. African Journal of Biotechnology 2010;9(10):1514-6.
Selimuzzaman 2010 {published data only}
  • Selimuzzaman SM, Islam SJ, Nahar Z, Das R, Rahman MA, Rahman MA. Malariagen malaria Pf/Pv antigen rapid test: a simple and effective tool for diagnosis of malaria in the far-flung hilly areas of Bangladesh. Mymensingh Medical Journal 2010;19(1):94-9.
Sharew 2009 {published data only}
  • Sharew B, Legesse M, Animut A, Jima D, Medhim G, Erkko B. Evaluation of the performance of CareStart Malaria Pf/Pv Combo and Paracheck Pf tests for the diagnosis of malaria in Wondo Genet, southern Ethiopia. Acta Tropica 2009;111(3):321-4.
Singh 2000a {published data only}
  • Singh N, Saxena A, Valecha N. Field evaluation of the ICT Malaria Pf/Pv immunochromatographic test for diagnosis of Plasmodium falciparum and P. vivax infection in forest villages in Chhindwara, central India. Tropical Medicine and International Health 2000;5(11):765-70.
Singh 2003 {published data only}
  • Singh N, Valecha N, Nagpal AC, Mishra SS, Varma HS, Subbaro SK. The hospital- and field-based performances of the OptiMAL tests, for malaria diagnosis and treatment monitoring in central India. Annals of Tropical Medicine and Parasitology 2003;97(1):5-13.
Singh 2010 {published data only}
  • Singh N, Shukla MM, Shukla MK, Mehra RK, Sharma S, Bharti PK, et al. Field and laboratory comparative evaluation of rapid malaria diagnostic tests versus traditional and molecular techniques in India. Malaria Journal 2010;9:191.
Tjitra 1999 {published data only}
  • Tjitra E, Suprianto S, Dyer M, Currie BJ, Anstey NM. Field evaluation of the ICT malaria Pf/Pv immunochromatographic test in detection of Plasmodium falciparum and Plasmodium vivax in patients with a presumptive clinical diagnosis of malaria in eastern Indonesia. Journal of Clinical Microbiology 1999;37(8):2412-7.
Trouvay 2013 {published data only}
  • Trouvay M, Palazon G, Berger F, Volney B, Blanchet D, Faway E, et al. High performance of histidine-rich protein 2 based rapid diagnostic tests in French Guiana are explained by the absence of pfhrp2 gene deletion in P. falciparum. PLoS One 2013;8(9):e74269.
Valecha 2003 {published data only}
  • Valecha N, Singh N, Yadav RS, Dev V, Aggarwal A, Subbarao SK. Field evaluation of OptiMAL48 rapid malaria diagnostic test in India. Acta Parasitologica 2003;48(3):229-32.
van den Broek 2006 {published data only}
  • van den Broek I, Hill O, Gordillo F, Angarita B, Hamade P, Counihan H, et al. Evaluation of three rapid tests for diagnosis of P. falciparum and P. vivax malaria in Colombia. American Journal of Tropical Medicine and Hygiene 2006;75(6):1209-15.
Wongsrichanalai 2003 {published data only}
  • Wongsrichanalai G, Arevalo I, Laoboonchai A, Yingyuen K, Miller RS, Magill AJ, et al. Rapid diagnostic devices for malaria: field evaluation of a new prototype immunochromatographic assay for the detection of Plasmodium falciparum and non-falciparumPlasmodium. American Journal of Tropical Medicine and Hygiene 2003;69(1):26-30.
Xiaodong 2013 {published data only}
  • Xiaodong S, Tambo E, Chun W, Zhibin C, Yan D, Jian W, et al. Diagnostic performance of CareStartTM malaria HRP2/pLDH (Pf/pan) combo test versus standard microscopy on falciparum and vivax malaria between China-Myanmar endemic borders. Malaria Journal 2013;12:6.
Yan 2013 {published data only}
  • Yan J, Li N, Wei X, Li P, Zhao Z, Wang L, et al. Performance of two rapid diagnostic tests for malaria diagnosis at the China-Myanmar border area. Malaria Journal 2013;12:73.

References to studies excluded from this review

Abeku 2008 {published data only}
  • Abeku TA, Kristan M, Jones C, Beard J, Mueller DH, Okia M, et al. Determinants of the accuracy of rapid diagnostic tests in malaria case management: evidence from low and moderate transmission settings in the East African highlands. Malaria Journal 2008;7:202.
Abul Faiz 2000 {published data only}
  • Abul Faiz M, Rashid R, Palit R, Rahman MR, BinYunus E, Hussain A, et al. ParaSight-F test results in cerebral malaria patients before and after treatment in Chittagong Medical College Hospital, Bangladesh. Transactions of the Royal Society of Tropical Medicine and Hygiene 2000;94(1):56-7.
Ademowo 2012 {published data only}
  • Ademowo G. Evaluation of the relative performance of rapid diagnostic test products (Partec and Paracheck-Pf) in the diagnosis of malaria in febrile children. 6th EDCTP Forum: Strengthening Research Partnerships for Better Health and Sustainable Development Addis Ababa Ethiopia; 2011 09-12 Oct; Addis Ababa. Tropical Medicine and International Health. 2012:58-9.
Adesanmi 2011 {published data only}
A-Elgayoum 2009 {published data only}
  • A-Elgayoum SME, El-Feki AE-KA, Mahgoub BA, El-Rayah el-A, Giha HA. Malaria overdiagnosis and burden of malaria misdiagnosis in the suburbs of central Sudan: special emphasis on artemisinin-based combination therapy era. Diagnostic Microbiology and Infectious Disease 2009;64(1):28-34.
Afzaal 2001 {published data only}
  • Afzaal S, Singh M, Fatima S, Koshy AA. Rapid diagnostic tests for malaria. Journal of the Association of Physicians of India 2001;49:261-5.
Ahmad 2003 {published data only}
  • Ahmad SQ, Abbasi SA, Tariq MA, Mirza SA, Salamat A. Evaluation of Plasmodium-lactate dehydrogenase based immunochromatographic kit for the diagnosis of malaria. Journal of the College of Physicians and Surgeons of Pakistan 2003;13(3):176-7.
Ahmed 2010 {published data only}
  • Ahmed MU, Mahmud MC, Shamsuzzaman AK, Musa AK, Ahmed SU, Alam M, et al. Role of immunochromatographic test for rapid diagnosis of malaria. Mymensingh Medical Journal 2010;19(1):106-9.
Albertini 2012 {published data only}
  • Albertini A, Djalle D, Faye B, Gamboa D, Luchavez J, Mationg ML, et al. Preliminary enquiry into the availability, price and quality of malaria rapid diagnostic tests in the private health sector of six malaria-endemic countries. Tropical Medicine and International Health 2012;17(2):147-52.
Allen 2011 {published data only}
  • Allen LK, Hatfield JM, DeVetten G, Ho JC, Manyama M. Reducing malaria misdiagnosis: the importance of correctly interpreting Paracheck Pf "faint test bands" in a low transmission area of Tanzania. BMC Infectious Diseases 2011;11:308.
Anonymous 2005 {published data only}
  • Anonymous. Micro moves against malaria. New Scientist 2005;187(2517):53.
Ansah 2008 {published data only}
  • Ansah EK. A comparison of microscopy with rapid diagnostic tests for malaria in rural Ghana. American Journal of Tropical Medicine and Hygiene 2008;79(6):91.
Ansah 2010 {published data only}
  • Ansah EK, Narh-Bana S, Epokor M, Akanpigbiam S, Quartey AA, Gyapong J, et al. Rapid testing for malaria in settings where microscopy is available and peripheral clinical where only presumptive treatment is available: a randomised controlled trial in Ghana. BMJ 2010;340:c930.
Araz 2000 {published data only}
  • Araz E, Tanyuksel M, Ardic N, Tabuk C. Performance of a commercial immunochromatographic test for the diagnosis of vivax malaria in Turkey. Transactions of the Royal Society of Tropical Medicine and Hygiene 2000;94(1):55-6.
Arcanjo 2007 {published data only}
  • Arcanjo AL, de Lacerda MVG, Alecrim WD, Alecrim MDC. Evaluation of the Optimal-IT® and ICT P.f./P.v® rapid dipstick tests for diagnosing malaria within primary healthcare in the municipality of Manaus, Amazonas [Avaliação dos testes rápidos Optimal-IT® e ICTP.f./P.v.® para o diagnóstico da malária, na Atenção Básica de Saúde, no município de Manaus, Amazonas]. Revista Da Sociedade Brasileira de Medicina Tropical 2007;40(1):88-90.
Ardic 2012 {published data only}
Arora 2003 {published data only}
  • Arora S, Gaiha M, Arora A. Role of the Parasight-F test in the diagnosis of complicated Plasmodium falciparum malarial infection. Brazilian Journal of Infectious Diseases 2003;7(5):332-8.
Arróspide 2004a {published data only}
  • Arróspide N, Puray C, Guzmán E, Verano M, Medina S, Mendizábal S, et al. Use of rapid tests for detecting Plasmodium falciparum in blood donors in Peru [Uso de pruebas rápidas immunocromatográficas para la detección de Plasmodium falciparum en donantes de sangre en Perú]. Revista Peruana de Medicina Experimental y Salud Pública 2004;21(2):76-82.
Arróspide 2004b {published data only}
  • Arróspide NV, Marquiño WQ, Gutiérrez SG. Evaluation of an immunoassay ICT P.f/P.v for the diagnosis of Plasmodium falciparum and Plasmodium vivax in the local macroregion of northern Peru [Evaluación de una prueba inmunocromatográfica ICT P.f/P.v para el diagnóstico de malaria por Plasmodium falciparum y Plasmodium vivax en establecimientos de la macroregión norte del Perú]. Revista Peruana de Medicina Experimental y Salud Pública 2004;21(3):134-8.
Arróspide 2006 {published data only}
  • Arróspide V, Flores RP, Ruiz JC. Evaluation of a rapid test based on pLDH detection for the diagnosis of malaria in endemic areas of Peru [Evaluación de una prueba rápida basada para el diagnóstico de malaria en áreas endémicas del Perú]. Revista Peruana de Medicina Experimental y Salud Pública 2006;23(2):81-6.
Ashley 2009 {published data only}
  • Ashley EA, Touabi M, Ahrer M, Hutagalung R, Htun K, Luchavez J, et al. Evaluation of three parasite lactate dehydrogenase-based rapid diagnostic tests for the diagnosis of falciparum and vivax malaria. Malaria Journal 2009;8:241.
  • Ashley EA, Touabi M, Ahrer M, Hutagalung R, Htun K, Lwin M, et al. Evaluation of 3 rapid diagnostic tests: CareStartTM Malaria 3 line pLDH (pan, Pf), Optimal-IT® PLDH (pan, Pf) and CarestartTM 2 line pLDH (pan) for the diagnosis of malaria in Myanmar. American Journal of Tropical Medicine and Hygiene 2008;79(6):966.
Aslan 2001 {published data only}
  • Aslan G, Ulukanligil M, Seyrek A, Erel O. Diagnostic performance characteristics of rapid dipstick test for Plasmodium vivax malaria. Memórias do Instituto Oswaldo Cruz 2001;96(5):683-6.
Assal 1999 {published data only}
  • Assal A, Kauffmann-Lacroix C, Rodier MH, Dardé ML, Houssay D, Jacquemin JL. Comparison of two techniques for detection of anti-Plasmodium falciparum antibodies: Falciparum-spot IF (Biomerieux) and Malaria IgG Celisa (BMD). Transfusion Clinique et Biologique 1999;6(2):119-23.
Avila 2002 {published data only}
  • Avila PE, Kirchgatteri K, Brunialti KCS, Oliveira AM, Siciliano RF, Di Santi SM. Evaluation of a rapid dipstick test, Malar-check, for the diagnosis of Plasmodium falciparum malaria in Brazil. Revista do Instituto de Medicina Tropical de São Paulo 2002;44(5):293-6.
Ayeh-Kumi 2011 {published data only}
  • Ayeh-Kumi PF, Akalifa BG, Obeng Nkrumah N, Asmah RH, Dayie NTKD. Performance of rapid DiaMed OptiMal-IT® malaria test in an endemic Ghanaian setting. Journal of Parasitic Diseases 2011;35(2):129-33.
Azazy 2004 {published data only}
  • Azazy AA. Performance and accuracy of an immunodiagnostic antigen detection test in diagnosing Plasmodium falciparum among Yemeni patients. Annals of Saudi Medicine 2004;24(1):50-1.
Azikiwe 2012 {published data only}
  • Azikiwe CCA, Ifezulike CC, Siminialayi IM, Amazu LU, Enye JC, Nwakwunite OE. A comparative laboratory diagnosis of malaria: Microscopy versus rapid diagnostic test kits. Asian Pacific Journal of Tropical Biomedicine 2012;2(4):307-10.
Babacar 2008 {published data only}
  • Babacar F, Ndiaye JL, Diallo I, Tine RC, Seck I, Ba-Fall F, et al. Feasibility of the rapid diagnostic tests (RDTs) field use for malaria case management in Senegal. American Journal of Tropical Medicine and Hygiene 2008;79(6):967.
Baiden 2012 {published data only}
  • Baiden F, Webster J, Tivura M, Delimini R, Berko Y, Amenga-Etego S, et al. Accuracy of rapid tests for malaria and treatment outcomes for malaria and non-malaria cases among under-five children in rural Ghana. PLoS One 2012;7(4):e34073.
Baltzell 2013 {published data only}
  • Baltzell KA, Shakely D, Hsiang M, Kemere J, Ali AS, Björkman A, et al. Prevalence of PCR detectable malaria infection among febrile patients with a negative Plasmodium falciparum specific rapid diagnostic test in Zanzibar. American Journal of Tropical Medicine and Hygiene 2013;88(2):289-91.
Banchongaksorn 1996 {published data only}
  • Banchongaksorn T, Yomokgul P, Panyim S, Rooney W, Vickers P. A field trial of the ParaSight-F test for the diagnosis of Plasmodium falciparum infection. Transactions of the Royal Society of Tropical Medicine and Hygiene 1996;90(3):244-5.
Banchongaksorn 1997 {published data only}
  • Banchongaksorn T, Prajakwong S, Rooney W, Vickers P. Operational trial of ParaSight-F (dipstick) in the diagnosis of falciparum malaria at the primary health care level. Southeast Asian Journal of Tropical Medicine and Public Health 1997;28(2):243-6.
Barber 2013 {published data only}
  • Barber BE, William T, Grigg MJ, Piera K, Yeo TW, Anstey NM. Evaluation of the sensitivity of a pLDH-based and an aldolase-based rapid diagnostic test for diagnosis of uncomplicated and severe malaria caused by PCR-confirmed Plasmodium knowlesi, Plasmodium falciparum, and Plasmodium vivax. Journal of Clinical Microbiology 2013;51(4):1118-23.
Bartoloni 1998 {published data only}
  • Bartoloni A, Strohmeyer M, Sabatinelli G, Benucci M, Serni U, Paradisi F. False positive ParaSight-F test for malaria in patients with rheumatoid factor. Transactions of the Royal Society of Tropical Medicine and Hygiene 1998;92(1):33-4.
Bassene 2009 {published data only}
  • Bassene H, Kenge P, Ndiath MO, Sokhna C, Dupressoir T, Fontenille D, et al. Comparison of PCR, ELISA-CSP and direct microscopic observation methods for the detection of Plasmodium falciparum sporozoites in Anopheles gambiae M in Sengal. Bulletin de la Société de Pathologie Exotique 2009;102(4):233-7.
Bassett 1991 {published data only}
  • Bassett MT, Taylor P, Bvirakare J, Chiteka F, Govera E. Clinical diagnosis of malaria: can we improve?. Journal of Tropical Medicine and Hygiene 1991;94(1):65-9.
Batwala 2011 {published data only}
  • Batwala V, Magnussen P, Hansen KS, Nuwaha F. Cost-effectiveness of malaria microscopy and rapid diagnostic tests versus presumptive diagnosis: implications for malaria control in Uganda. Malaria Journal 2011;10:372.
Beadle 1994 {published data only}
  • Beadle C, Long GW, Weiss WR, McElroy PD, Maret SM, Oloo AJ, et al. Diagnosis of malaria by detection of Plasmodium falciparum HRP-2 antigen with a rapid dipstick antigen-capture assay. The Lancet 1994;343(8897):564-8.
Bechem 1999 {published data only}
  • Bechem NN, Leke RFG, Tietche F, Taylor DW. Evaluation of rapid test for histidine rich protein 2 for diagnosis of Plasmodium falciparum infection in Cameroonian children. Transactions of the Royal Society of Tropical Medicine and Hygiene 1999;93(1):46.
Beg 2005 {published data only}
  • Beg MA, Ali SS, Haqqee R, Khan MA, Qasim Z, Hussain R, et al. Rapid immunochromatography-based detection of mixed-species malaria infection in Pakistan. Southeast Asian Journal of Tropical Medicine and Public Health 2005;36(3):562-4.
Belizario 2005 {published data only}
  • Belizario VY, Pasay CJ, Bersabe MJ, de Leon WU, Guerrero DM, Bugaoisan VM. Field evaluation of malaria rapid diagnostic tests for the diagnosis of P. falciparum and non-P. falciparum infections. Southeast Asian Journal of Tropical Medicine and Public Health 2005;36(3):552-61.
Bell 2005 {published data only}
  • Bell DR, Wilson DW, Martin LB. False-positive results of a Plasmodium falciparum histidine-rich protein 2-detecting malaria rapid diagnostic test due to high sensitivity in a community with fluctuating low parasite density. American Journal of Tropical Medicine and Hygiene 2005;73(1):199-203.
Bell 2006 {published data only}
  • Bell D, Peeling RW, WHO-Regional Office for the Western Pacific/TDR. Evaluation of rapid diagnostic tests: malaria. Nature 2006;4(9 Suppl):S34-8.
Bellagra 1998 {published data only}
Bendezu 2008 {published data only}
  • Bendezu J. Field evaluation of a rapid malaria diagnostic test (Parascreen) for malaria diagnosis in the Peruvian Amazon. American Journal of Tropical Medicine and Hygiene 2008;79(6):960.
Berens-Riha 2009 {published data only}
Bhandari 2008 {published data only}
  • Bhandari TS, Rai S, Naik R, Raghuveer CV. Specificity and sensitivity of rapid diagnostic test in the detection of falciparum malaria. Indian Journal of Medical Research 2008;127:638.
Bhat 2012 {published data only}
  • Bhat Sandhya K, Sastry Apurba S, Nagaraj ER, Mannur S, Sastry Anand S. Laboratory diagnosis of malaria by conventional peripheral blood smear examination with Quantitative Buffy Coat (QBC) and Rapid Diagnostic Tests (RDT) - A comparative study. International Journal of Collaborative Research on Internal Medicine and Public Health 2012;4(10):1746-55.
Bhatt 1994 {published data only}
  • Bhatt KM. Laboratory diagnosis of malaria: an overview. African Journal of General Practice 1994;1(1):12.
Birku 1999 {published data only}
  • Birku Y, Welday D, Ayele D, Shepherd A. Rapid diagnosis of severe malaria based on the detection of Pf-HRP-2 antigen. Ethiopian Medical Journal 1999;37(3):173-9.
Bisoffi 2009a {published data only}
  • Bisoffi Z, Sirima BS, Angheben A, Lodesani C, Gobbi F, Tinto H, et al. Rapid malaria diagnostic tests vs. clinical management of malaria in rural Burkina Faso: safety and effect on clinical decisions. A randomized trial. Tropical Medicine and International Health 2009;14(5):491-8.
Bisoffi 2009b {published data only}
Bisoffi 2011 {published data only}
  • Bisoffi Z, Sodiomon Sirima B, Meheus F, Lodesani C, Gobbi F, Angheben F, et al. A cost benefit analysis of malaria rapid diagnostic tests for adults and children in Burkina Faso. 7th European Congress on Tropical Medicine and International Health; 2011 03-06 Oct; Barcelona. Tropical Medicine and International Health. 2011:107.
Biswas 2004 {published data only}
  • Biswas S. Inter-test comparison between filter paper absorbed blood eluate and serum for malaria serology by enzyme immunoassay: an operational feasibility. Journal of Immunoassay and Immunochemistry 2004;25(4):399-410.
Biswas 2006 {published data only}
Bjorkman 2011 {published data only}
  • Bjorkman A. The use of rapid diagnostic tests for measuring malaria transmission. 7th European Congress on Tropical Medicine and International Health; 2011 03-06 Oct; Barcelona. Tropical Medicine and International Health. 2011:12.
Bojang 1999 {published data only}
  • Bojang KA. The diagnosis of Plasmodium falciparum infection in Gambian children, by field staff using the rapid, manual, ParaSight-F test. Annals of Tropical Medicine and Parasitology 1999;93(7):685-7.
Bouchaud 2000 {published data only}
  • Bouchaud O, Houzé S, Longuet C, di Piazza JP, Ruggieri C, Sécardin Y, et al. Use of the Parasight-F diagnostic test for imported malaria in a travel clinic. American Journal of Tropical Medicine and Hygiene 2000;63(1-2):76-9.
Bouyou Akotet 2013 {published data only}
  • Bouyou Akotet MK, Mawili-Mboumba DP, Madoungou B, Kombila M. Performances of malaria P.f/Pan rapid test device Acon® (Pf HRP2/pan aldolase) and malaria Pf rapid test device Acon® (Pf HRP2) for the diagnosis of malaria in adults and children living in Gabon, Central Africa. Diagnostic Microbiology and Infectious Disease 2013;77(1):58-63.
Brenier-Pinchart 2000 {published data only}
  • Brenier-Pinchart MP, Pinel C, Croisonnier A, Brion JP, Faure O, Ponard D, et al. Diagnosis of malaria in non-endemic countries by the ParaSight-F test. American Journal of Tropical Medicine and Hygiene 2000;63(3-4):150-2.
Bruxvoort 2008 {published data only}
  • Bruxvoort K, Khatib RA, Abdulah SM, Kahigwa E, Kachur SP, McMorrow ML. Variable sensitivity of malaria rapid diagnostic tests in household surveys - Tanzania 2006. American Journal of Tropical Medicine and Hygiene 2008;79(6):957.
Bualombai 2003 {published data only}
  • Bualombai P, Prajakwong S, Aussawatheerakul H, Congpuong K, Sudathip S, Thimasarn K, et al. Determining cost-effectiveness and cost-component of three malaria diagnostic models being used in remote non-microscope areas. Southeast Asian Journal of Tropical Medicine and Public Health 2003;34(2):322-33.
Bualombai 2008 {published data only}
  • Bualombai P, Balachandra K, Dhepaksorn P, Congpuong K, Satimai W. The validation of DMSC Malaria Pf/Pv rapid diagnostic device for the detection of non-falciparum malaria in Thailand in 2006. American Journal of Tropical Medicine and Hygiene 2008;79(6):958.
Buchachart 2004 {published data only}
  • Buchachart K, Krudsood S, Nacher M, Chindanond D, Rungmatcha P, Kano S, et al. Evaluation of the KAT-Quick Malaria Rapid Test for rapid diagnosis of falciparum malaria in Thailand. Southeast Asian Journal of Tropical Medicine and Public Health 2004;35(1):35-7.
Buhalata 2011 {published data only}
  • Buhalata SN, Massaga JJ. Performance of ParaHIT and OptiMAL tests in the diagnosis of malaria in Mwanza, north-western Tanzania. Tanzania Journal of Health Research 2011;13(1):48-53.
Bujanover 2002 {published data only}
  • Bujanover S, Shwartz E. Quick detection of malaria. Israel Medical Association Journal 2002;4(12):1167.
Cabezas 2004 {published data only}
  • Cabezas CS, Arróspide NV, Marquiño WQ, Gutiérrez SS, Álvarez EM, Chuquipiondo JR, et al. Evaluation of the use of a rapid immunochromatographic test for health workers to diagnose malaria in rural areas of the Peruvian Amazon [Evaluación del uso de una prueba rápida inmunocromatográfica en promotores de salud para el diagnóstico de la malaria en áreas rurales de la Amazonia peruana]. Revista Peruana de Medicina Experimental y Salud Publica 2004;20(1):4-11.
Caraballo 1996 {published data only}
  • Caraballo A, Ache A. The evaluation of a dipstick test for Plasmodium falciparum in mining areas of Venezuela. American Journal of Tropical Medicine and Hygiene 1996;55(5):482-4.
Carmona Fonseca 2010 {published data only}
  • Carmona Fonseca J, Gallego AF, Flórez EA, Agudelo García OM, Maestre Buitrago A. Now ICT malaria Pf/Pv® frente a microscopía (gota gruesa-extendido) para diagnóstico de malaria en Urabá (Colombia). Iatreia 2010;23(2):137-45.
Cavallo 1997 {published data only}
  • Cavallo JD, Hernandez E, Gerome P, Plotton N, Debord T, Le Vagueresse R. Serum HRP-2 antigens and imported Plasmodium falciparum malaria: comparison of ParaSight-F and ICT malaria P.f. Médecine Tropicale 1997;57(4):353-6.
Chaijaroenkul 2011 {published data only}
  • Chaijaroenkul W, Wongchai T, Ruangweerayut R, Na-Bangchang K. Evaluation of rapid diagnostics for Plasmodium falciparum and P. vivax in Mae Sot malaria endemic area, Thailand. Korean Journal of Parasitology 2011;49(1):33-8.
Chatterjee 2008 {published data only}
  • Chatterjee K, Chand P. Evaluation of the Rapid in Bios malaria kit for the detection of malaria LDH antigen in human blood. Vox Sanguinis 2008;95:31.
Cheng 2006 {published data only}
  • Cheng A, Bell D. Evidence behind the WHO guidelines: hospital care for children: what is the precision of rapid diagnostic tests for malaria?. Journal of Tropical Pediatrics 2006;52(6):386-9.
Chilton 2006 {published data only}
  • Chilton D, Malik ANJ, Armstrong M, Kettelhut M, Parker-Williams J, Chiodini PL. Use of rapid diagnostic tests for diagnosis of malaria in the UK. Journal of Clinical Pathology 2006;59(8):862-6.
Chinkhumba 2010 {published data only}
  • Chinkhumba J, Skarbinksi J, Chilima B, Campbell C, Ewing V, San Joaquin M, et al. Comparative field performance and adherence to test results of four rapid diagnostic tests among febrile patients more than five years of age in Blantyre, Malawi. Malaria Journal 2010;9:209.
Chinkhumba 2012 {published data only}
  • Chinkhumba J, Nyanda M, Skarbinski J, Mathanga DP. Performance of two malaria rapid diagnostic tests in febrile adult patients with and without human immunodeficiency virus-1 infection in Blantyre, Malawi. American Journal of Tropical Medicine and Hygiene 2012;86(2):199-202.
Chiodini 1998 {published data only}
Chiodini 2005 {published data only}
Chitkara 2004 {published data only}
  • Chitkara A, Ahmed FU. Test for rapid diagnosis of Plasmodium falciparum infection. Indian Journal of Community Medicine 2004;23:173-4.
Cho 2001 {published data only}
Cho 2011 {published data only}
  • Cho C-H, Nam MH, Kim JS, Han ET, Lee WJ, Oh JS, et al. Genetic variability in Plasmodium vivax aldolase gene in Korean isolates and the sensitivity of the Binax Now malaria test. Tropical Medicine and International Health 2011;16(2):223-6.
Cnops 2011 {published data only}
Coleman 2002a {published data only}
  • Coleman RE, Maneechai N, Ponlawat A, Kumpitak C, Rachapaew N, Miller RS, et al. Short report: Failure of the OptiMAL rapid malaria test as a tool for the detection of asymptomatic malaria in an area of Thailand endemic for Plasmodium falciparum and P. vivax. American Journal of Tropical Medicine and Hygiene 2002;67(6):563-5.
Coleman 2002b {published data only}
  • Coleman RE, Maneechai N, Rachapaew N, Kumpitak C, Soyseng V, Miller RS, et al. Field evaluation of the ICT Malaria Pf/Pv immunochromatographic test for the detection of asymptomatic malaria in a Plasmodium falciparum/vivax endemic area in Thailand. American Journal of Tropical Medicine and Hygiene 2002;66(4):379-83.
Cong le 2002 {published data only}
  • Cong le D, Sergiev VP, Rabinovich SA, Nhah DH, Huong NV, Morozov EN, et al. Efficiency and specificity of the KAT-test for rapid diagnosis of falciparum malaria. Meditsinskaia Parazitologiia i Parazitarnye Bolezni 2002;2:17-20.
Cooke 1999 {published data only}
  • Cooke AH, Chiodini PL, Doherty T, Moody AH, Ries J, Pinder M. Comparison of a parasite lactate dehydrogenase-based immunochromatographic antigen detection assay (OptiMAL) with microscopy for the detection of malaria parasites in human blood samples. American Journal of Tropcial Medicine and and Hygiene 1999;60(2):173-6.
Craig 1997 {published data only}
  • Craig MH, Sharp BL. Comparative evaluation of four techniques for the diagnosis of Plasmodium falciparum infections. Transactions of the Royal Society of Tropical Medicine and Hygiene 1997;91(3):279-82.
Craig 2002 {published data only}
  • Craig MH, Bredenkamp BL, Williams CHV, Rossouw EJ, Kelly VJ, Kleinschmidt I, et al. Field and laboratory comparative evaluation of ten rapid malaria diagnostic tests. Transactions of the Royal Society of Tropical Medicine and Hygiene 2002;96(3):258-65.
Cropley 2000 {published data only}
  • Cropley IM, Lockwood DN, Mack D, Pasvol G, Davidson RN. Rapid diagnosis of Falciparum malaria by using the ParaSight F test in travellers returning to the United Kingdom: prospective study. British Medical Journal 2000;321(7259):484-5.
Cuadros 2007 {published data only}
  • Cuadros J, Martín-Rabadán P, Merino FJ, Delgado-Irribarren A, Garcia-Bujalance S, Rubio JM. Malaria diagnosis by NOW ICT and expert microscopy in comparison with multiplex polymerase chain reaction in febrile returned travellers. European Journal of Clinical Microbiology and Infectious Diseases 2007;26(9):671-3.
Davoodian 2011 {published data only}
  • Davoodian P, Daryanavard A, Safari R, Eqbal Eftekhaari T, Khalilzadeh M, Fekri S, et al. Rapid diagnosing test in malaria screening. 21st ECCMID/27th ICC; 2011 07-10 May; Milan. Clinical Microbiology and Infection. 2011:S396.
Dawoud 2008 {published data only}
  • Dawoud HA, Ageely HM, Heiba AA. Comparison of two commercial assays and microscopy with PCR for diagnosis of malaria. Journal of the Egyptian Society of Parasitology 2008;38(2):329-38.
de Carsalade 2009 {published data only}
  • de Carsalade GY, Lam Kam R, Lepere JF, de Brettes A, Peyramond D. Can the thick drop/smear examination for malaria be replaced by a rapid diagnostic test in first intention? The Mayotte experience. Médecine et Maladies Infectieuses 2009;39(1):36-40.
de Dominguez 1996 {published data only}
  • de Dominguez N, Rodriguez-Acosta A. Glutamate dehydrogenase antigen detection in Plasmodium falciparum infections. Korean Journal of Parasitology 1996;34(4):239-46.
Delaunay 2008 {published data only}
Deletoille 1987 {published data only}
  • Deletoille P, Prou O. Value of rapid diagnosis of Plasmodium falciparum using indirect monoclonal immunofluorescence. Bulletin de la Société de Pathologie Exotique et de Ses Filiales 1987;80(3 Pt 2):569-80.
De Monbrison 2004 {published data only}
  • De Monbrison F, Gérome P, Chaulet JF, Wallon M, Picot S, Peyron F. Comparative diagnostic performance of two commercial rapid tests for malaria in a non-endemic area. European Journal of Clinical Microbiology and Infectious Diseases 2004;23(10):784-6.
de Oliveira 2007 {published data only}
  • de Oliveira AM, Skarbinski J, Ouma PO, Kariuki S, Barnwell JW, Otieno K, et al. Malaria rapid diagnostic test use in performance by facility-based health workers in western Kenya. American Journal of Tropical Medicine and Hygiene 2007;77:338 (abstract number).
  • de Oliveira AM, Skarbinski J, Ouma PO, Kariuki S, Barnwell JW, Otieno K, et al. Peformance of malaria rapid diagnostic tests as part of routine malaria case management in Kenya. American Journal of Tropical Medicine and Hygiene 2009;80(3):470-4.
Devi 2002 {published data only}
  • Devi G, Indumathi VA, Sridharan D, Srinivas BPR, Sandhya BMR. Evaluation of paraHIT strip test for diagnosis of malaria infection. Indian Journal of Medical Sciences 2002;56(10):489-94.
Diarra 2012 {published data only}
  • Diarra A, Nébié I, Tiono A, Sanon S, Soulama I, Ouédraogo A, et al. Seasonal performance of a malaria rapid diagnosis test at community health clinics in a malaria-hyperendemic region of Burkina Faso. Parasites and Vectors 2012;5:103.
Dietze 1995 {published data only}
  • Dietze R, Perkins M, Boulos M, Luz F, Reller B, Corey G R. The diagnosis of Plasmodium falciparum infection using a new antigen detection system. American Journal of Tropical Medicine and Hygiene 1995;52(1):45-9.
Di Perry 1997 {published data only}
  • Di Perry G, Olliaro P, Nardi S, Allegranzi B, Deganello R, Vento S, et al. The Parasight-F rapid dipstick antigen capture assay for monitoring parasite clearance after drug treatment for Plasmodium falciparum malaria. Transactions of the Royal Society of Tropical Medicine and Hygiene 1997;91(4):403-5.
Di Santi 2011 {published data only}
  • Di Santi SM, Lima G, Levi JE, Geraldi M, Arroyo Sanchez MC, Segurado AA, et al. Real-time PCR, nested PCR and immunoassay in blood samples processed in pool, as a platform for molecular andserological diagnosis of malaria on large-scale. 7th European Congress on Tropical Medicine and International Health; 2011 03-06 October; Barcelona. Tropical Medicine and International Health. 2011:129.
Drakeley 2009 {published data only}
  • Drakeley C, Reyburn H. Out with the old, in with the new: the utility of rapid diagnostic tests for malaria diagnosis in Africa. Transactions of the Royal Society of Tropical Medicine and Hygiene 2009;103(4):333-7.
Dubarry 1990 {published data only}
  • Dubarry M, Luilier M, Malot N, Bayard P, Lambin P, Prou O, et al. Enzyme immunoassays for detection of malarial antigens in human plasma by Plasmodium falciparum monoclonal antibodies. American Journal of Tropical Medicine and Hygiene 1990;43(2):116-23.
Durand 2005 {published data only}
  • Durand F, Faure O, Brion JP, Pelloux H. Invalid result of Plasmodium falciparum malaria detection with the BinaxNOW Malaria rapid diagnostic test. Journal of Medical Microbiology 2005;54(Pt 11):1115.
Durand 2007 {published data only}
  • Durand F, Crassous B, Fricker-Hidalgo H, Carpentier F, Brion JP, Grillot R, et al. Performance of the Now Malaria rapid diagnostic test with returned travellers: a 2-year retrospective study in a French teaching hospital. Clinical Microbiology and Infection 2007;11(11):903-7.
Durrheim 1998 {published data only}
  • Durrheim DN, Govere J, la Grange JJP, Mabuza A. Rapid immunochromatographic diagnosis and Rolling Back Malaria - experiences from an African control programme. African Journal of Medicine and Medical Sciences 2001;30:Suppl: 21-4.
  • Durrheim DN, la Grange JJ, Govere J, Mngomezulu NM. Accuracy of a rapid immunochromatographic card test for Plasmodium falciparum in a malaria control programme in South Africa. Transactions of the Royal Society of Tropical Medicine and Hygiene 1998;92(1):32-3.
Dyer 2000 {published data only}
  • Dyer ME, Tjitra E, Currie BJ, Anstey NM. Failure of the 'pan-malarial' antibody of the ICT Malaria P.f/P.v immunochromatographic test to detect symptomatic Plasmodium malariae infection. Transactions of the Royal Society of Tropical Medicine and Hygiene 2000;94(5):518.
Dzakah 2013 {published data only}
  • Dzakah EE, Kang K, Ni C, Wang H, Wu P, Tang S, et al. Plasmodium vivax aldolase-specific monoclonal antibodies and its application in clinical diagnosis of malaria infections in China. Malaria Journal 2013;12:199.
Eisen 2000 {published data only}
  • Eisen DP, Saul A. Disappearance of pan-malarial antigen reactivity using the ICT Malaria P.f/P.v (TM) kit parallels decline of patent parasitaemia as shown by microscopy. Transactions of the Royal Society of Tropical Medicine and Hygiene 2000;94(2):169-70.
Elmardi 2009 {published data only}
  • Elmardi KA, Malik EM, Abdelgadir T, Ali SH, Elsyed AH, Mudather MA, et al. Feasibility and acceptability of home-based management of malaria strategy adapted to Sudan's conditions using artemisinin-based combination therapy and rapid diagnostic test. Malaria Journal 2009;8:39.
El-Moamly 2007 {published data only}
  • El Moamly AMAR. Antigen capture immuno-chromatographic strip format in detecting parasite-specific lactate dehydrogenase to diagnose malaria in non-immune patients. Journal of the Egyptian Society of Parasitology 2007;37(3):1017-30.
Endeshaw 2008 {published data only}
  • Endeshaw TG, Teshome NJ, Graves PM, Shargie EB, Ejigsemahu Y, Ayele B, et al. Evaluation of light microscopy and rapid diagnostic test for the detection of malaria under operational field conditions: a household survey in Ethiopia. Malaria Journal 2008;7:118.
Endeshaw 2010 {published data only}
  • Endeshaw T, Graves PM, Shargie EB, Gebre T, Ayele B, Yohannes G, et al. Comparison of Parascreen Pan/Pf, Paracheck Pf and light microscopy for detection of malaria among febrile patients, Northwest Ethiopia. Transactions of the Royal Society of Tropical Medicine and Hygiene 2010;104(7):467-74.
Existe 2010 {published data only}
  • Existe A, Freeman N, Boncy J, Magloire R, Vely JF, Chang M, et al. Rapid tests for malaria-Haiti 2010. Journal of the American Medical Association 2010;304(23):2585-6.
Falade 2013 {published data only}
  • Falade CO, Adesina-Adewole B, Dada-Adegbola HO, Ajayi IO, Akinyemi JO, Ademowo OG, et al. Evaluation of Paracheck-PfTM rapid malaria diagnostic test for the diagnosis of malaria among HIV-positive patients in Ibadan, south-western Nigeria. Pathogens and Global Health 2013;107(2):69-77.
Fan 2000 {published data only}
  • Fan B, Zhang ZX, Wen RS. Diagnosis of falciparum malaria using ICT. Chinese Journal of Parasitology and Parasitic Diseases 2000;18(5):281.
Fancony 2013 {published data only}
  • Fancony C, Sebastião YV, Pires JE, Gamboa D, Nery SV. Performance of microscopy and RDTs in the context of malaria prevalence survey in Angola: a comparison using PCR as the gold standard. Malaria Journal 2013;12:284.
Farcas 2003 {published data only}
  • Farcas GA, Zhong KJY, Lovegrove FE, Graham CM, Kain KC. Evaluation of the Binax NOW ICT test versus polymerase chain reaction and microscopy for the detection of malaria in returned travellers. American Journal of Tropical Medicine and Hygiene 2003;69(6):589-92.
Farcas 2004 {published data only}
Ferro 2002 {published data only}
  • Ferro BE, Gonzalez IJ, de Carvajal Fd, Palma GI, Saravia NG. Performance of OptiMAL® in the diagnosis of Plasmodium vivax and Plasmodium falciparum infections in a malaria referral center in Colombia. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro 2002;97(5):731-5.
Figueiredo Filho 2003 {published data only}
  • Figueiredo Filho AF, Figueredo MC, Nascimento JM, Calvosa VSP, Póvoa MM, Machado RLD. Performance of an immunochromatography test for vivax malaria in the Amazon region, Brazil. Revista de Saúde Pública 2003;37(3):390-2.
Fogg 2008 {published data only}
  • Fogg C, Twesigye R, Batwala V, Piola P, Nabasumba C, Kiguli J, et al. Assessment of three new parasite lactate dehydrogenase (pan-pLDH) tests for diagnosis of uncomplicated malaria. Transactions of the Royal Society of Tropical Medicine and Hygiene 2008;102(1):25-31.
Forney 2001 {published data only}
  • Forney JR, Magill AJ, Wongsrichanalai C, Sirichaisinthop J, Bautista CT, Heppner DG, et al. Malaria rapid diagnostic devices: performance characteristics of the ParaSight F device determined in a multisite field study. Journal of Clinical Microbiology 2001;39(8):2884-90.
  • Magill AJ, Wongrichalanai C, Forney JR, Bautista C, Sirichasinthop A, Andersen EM, et al. Performance characteristics of a prototype malaria rapid diagnostic device (MRDD) for the detection of Plasmodium falciparum and Plasmodium vivax. Clinical Infectious Diseases 2000;31(1):472.
Forney 2003 {published data only}
  • Forney JR, Wongsrichanalai C, Magill AJ, Craig LG, Sirichaisinthop J, Bautista CT, et al. Devices for rapid diagnosis of malaria: evaluation of prototype assays that detect Plasmodium falciparum histidine-rich protein 2 and a Plasmodium vivax-specific antigen. Journal of Clinical Microbiology 2003;41(6):2358-66.
Fryauff 1997 {published data only}
  • Fryauff DJ, Gomez-Saladin E, Purnomo, Sumawinata I, Sutamihardja MA, Tuti S, et al. Comparative performance of the ParaSight F test for detection of Plasmodium falciparum in malaria-immune and nonimmune populations in Irian Jaya, Indonesia. Bulletin of the World Health Organization 1997;75(6):547-52.
Fryauff 2000 {published data only}
  • Fryauff DJ, Purnomo, Sutamihardja MA, Elyazar IR, Susanti I, Krisin, et al. Performance of the OptiMAL assay for detection and identification of malaria infections in asymptomatic residents of Irian Jaya, Indonesia. American Journal of Tropical Medicine and Hygiene 2000;63(3-4):139-45.
Funk 1999 {published data only}
  • Funk M, Schlagenhauf P, Tschopp A, Steffen R. MalaQuick versus ParaSight F as a diagnostic aid in travellers' malaria. Transactions of the Royal Society of Tropical Medicine and Hygiene 1999;93(3):268-72.
Garavelli 2002 {published data only}
  • Garavelli PL. Diagnosis of malaria with immunochromatographic test: The Novara experience. Recenti Progressi in Medicina 2002;93(12):682.
Garcia 1996 {published data only}
  • Garcia M, Marlborough D. A rapid immunochromatographic tests (ICT) for the diagnosis of Plasmodium falciparum malaria. Journal of Parasitic Diseases 1996;20(1):64.
Gatti 2002 {published data only}
  • Gatti S, Bernuzzi AM, Bisoffi Z, Raglio A, Gulletta M, Scaglia M, et al. Multicentre study in patients with imported malaria, on the sensitivity and specificity of a dipstick test (ICT Malaria P.f./P.v.) compared with expert microscopy. Annals of Tropical Medicine and Parasitology 2002;96(1):15-8.
Gatti 2007 {published data only}
  • Gatti S, Gramegna M, Bisoffi Z, Raglio A, Gulletta M, Klersy C, et al. A comparison of three diagnostic techniques for malaria: a rapid diagnostic test (NOW Malaria), PCR and microscopy. Annals of Tropical Medicine and Parasitology 2007;101(3):195-204.
Gaye 1998 {published data only}
  • Gaye O, Diouf M, Dansokho EF, McLaughlin G, Diallo S. Diagnosis of Plasmodium falciparum malaria using ParaSight F, ICT malaria Pf and malaria IgG CELISA assays. Parasite 1998;5(2):189-92.
Gaye 1999 {published data only}
Gelaglie 2010 {published data only}
  • Gelaglie AK. Performance of four rapid diagnostic tests for diagnosis of falciparum and non-falciparum malaria in endemic areas of Gondar region, Northern Ethopia. 14th International Congress on Infectious Diseases (ICID); 2010 09-12 Mar; Miami. 14th International Congress on Infectious Diseases (ICID) Abstracts. 2010.
Gerstl 2009 {published data only}
  • Gerstl S, Dunkley S, Mukhtar A, De Smet M, Baker A, Maikere J. Assessment of two malaria rapid diagnostic tests, with follow-up of positive pLDH test results, in a hyperendemic falciparum malaria area. Tropical Medicine and International Health 2009;14(Suppl 2):92.
Ghanchi 2009 {published data only}
  • Ghanchi NK, Beg MA, Hussain R. Estimation of parasite load using rapid diagnostic test ICT (R) Now Malaria P.f/P.v in Plasmodium falciparum malaria. Scandinavian Journal of Infectious Diseases 2009;41(8):597-601.
Ghosh 2000 {published data only}
  • Ghosh SK, Titus Burk E, Valecha N, Murugendrappa MV, Sharma VP. Evaluation of a rapid immunochromatographic test (ICT) for detection of Plasmodium falciparum malaria in Karnataka, India. Journal of Parasitic Diseases 2000;24:39-42.
Ghouth 2012 {published data only}
  • Ghouth AS, Nasseb FM, Al-Kaldy KH. The accuracy of the first response histidine-rich protein2 rapid diagnostic test compared with malaria microscopy for guiding field treatment in an outbreak of falciparum malaria. Tropical Parasitology 2012;2(1):35-7.
Gillet 2009a {published data only}
  • Gillet P, Bosselaers K, Cnops L, Bottieau E, Van Esbroeck M, Jacobs J. Evaluation of the SD FK70 malaria Ag Plasmodium vivax rapid diagnostic test in a non-endemic setting. Malaria Journal 2009;8:129.
Gillet 2009b {published data only}
Gillet 2009c {published data only}
  • Gillet P, van Dijk DP, Bottieau E, Cnops L, Van Esbroeck M, Jacobs J. Test characteristics of the SD FK80 Plasmodium falciparum/ Plasmodium vivax malaria rapid diagnostic test in a non-endemic setting. Malaria Journal 2009;8:262.
Gillet 2011 {published data only}
  • Gillet P, Scheirlinck A, Stokx J, De Weggheleire A, Chaúque HS, Canhanga OD, et al. Prozone in malaria rapid diagnostics tests: how many cases are missed?. Malaria Journal 2011;10:166.
Gogtay 1999 {published data only}
  • Gogtay NJ, Kotwani RN, Rajgor D, Kanbur A, Karnad DR, Kshirsagar NA. Serial ParaSight-F test in patients with severe malaria. Indian Journal of Malariology 1999;36(3-4):94-5.
Gogtay 2003 {published data only}
  • Gogtay NJ, Dalvi SS, Rajgor D, Chogle AR, Karnad DR, Ramdas M, et al. Diagnostic and prognostic utility of rapid strip (OptiMAL and Paracheck) versus conventional smear microscopy in adult patients of acute, uncomplicated P. falciparum malaria in Mumbai, India. Journal of the Association of Physicians of India 2003;51:762-5.
Goh 2013 {published data only}
  • Goh XT, Lim YA, Vythilingam I, Chew CH, Lee PC, Ngui R, et al. Increased detection of Plasmodium knowlesi in Sandakhan division, Sabah as revealed by PlasmoNexTM. Malaria Journal 2013;12:264.
Gomes 2013 {published data only}
  • Gomes LT, Tada MS, Katsuragawa TH, Povoa MM, Viana GMR, Alecrim MdGC, et al. Low sensitivity of malaria rapid diagnostic tests stored at room temperature in the Brazilian Amazon region. Journal of Infection in Developing Countries 2013;7(3):243-52.
Gonzáles-Cerón 2005 {published data only}
  • González-Cerón L, Rodríguez MH, Betanzos AF, Abadía A. Efficacy of a rapid test to diagnose Plasmodium vivax in symptomatic patients of Chiapas, Mexico. Salud Pública de México 2005;47(4):282-7.
Grobusch 1999 {published data only}
Grobusch 2002 {published data only}
  • Grobusch MP, Hänscheid T, Zoller T, Jelinek T, Burchard GD. Rapid immunochromatographic malarial antigen detection unreliable for detecting Plasmodium malariae and Plasmodium ovale. European Journal of Clinical Microbiology and Infectious Diseases 2002;21(11):818-20.
Grobusch 2003a {published data only}
  • Grobusch MP, Hänscheid T, Göbels K, Slevogt H, Zoller T, Rögler G, et al. Sensitivity of P. vivax rapid antigen detection tests and possible implications for self-diagnostic use. Travel Medicine and Infectious Disease 2003;1(2):119-22.
Grobusch 2003b {published data only}
  • Grobusch MP, Hänscheid T, Göbels K, Slevogt H, Zoller T, Rögler G, et al. Comparison of three antigen detection tests for diagnosis and follow-up of falciparum malaria in travellers returning to Berlin, Germany. Parasitology Research 2003;89(5):354-7.
Gupta 2001 {published data only}
  • Gupta MK, Misra RN, Chawla N, Mani H, Chowdhry CN, Singh SP. Immunochromatographic test: a new dimensions in diagnosis of Plasmodium falciparum malaria. Medical Journal of the Armed Forces of India 2001;57(3):188-90.
Guthmann 2002 {published data only}
  • Guthmann JP, Ruiz A, Priotto G, Kiguli J, Bonte L, Legros D. Validity, reliability and ease of use in the field of five rapid tests for the diagnosis of Plasmodium falciparum malaria in Uganda. Transactions of the Royal Society of Tropical Medicine and Hygiene 2002;96(3):254-7.
Gutierrez 2005 {published data only}
  • Gutierrez Y, Paco G, Romero L, Gonzáles J‚ Peñar LM, Gimenez T. Fluorometers; a rapid and simple method for evaluating the Antimalarial Activity [Fluorometría; un método rápido y sencillo para evaluar la Actividad Antipalúdica]. Biofarbo 2005;13(13):3-10.
Hada 2011 {published data only}
  • Hada S, Das ML, Singh YI. Diagnostic methods of malaria in Eastern Nepal: a comparative study of traditional and two rapid diagnostic tests. Nepal Medical College Journal: NMCJ 2011;13(4):261-6.
Haditsch 2004 {published data only}
  • Haditsch M. Quality and reliability of current malaria diagnostic methods. Travel Medicine and Infectious Disease 2004;2(3-4):149-60.
Hance 2005 {published data only}
  • Hance P, Garnotel E, De Pina JJ, Vedy S, Ragot C, Chadli M, et al. Rapid immunochromatographic tests for detection of malaria: principles and strategies for use. Médecine Tropicale 2005;65(4):389-93.
Hänscheid 1999 {published data only}
Happi 2004 {published data only}
  • Happi CT, Gbotosho GO, Sowunmi A, Falade CO, Akinboye DO, Oladepo O, et al. Malaria diagnosis: false negative ParaSight-F tests in falciparum malaria patients in Nigeria. African Journal of Medicine and Medical Sciences 2004;33(1):15-8.
Harchut 2013 {published data only}
  • Harchut K, Standley C, Dobson A, Klaassen B, Rambaud-Althaus C, Althaus F, et al. Over-diagnosis of malaria by microscopy in the Kilombero Valley, Southern Tanzania: an evaluation of the utility and cost-effectiveness of rapid diagnostic tests. Malaria Journal 2013;12:159.
Hashizume 2006 {published data only}
  • Hashizume M, Kondo H, Murakami T, Kodama M, Nakahara S, Lucas MES, et al. Use of rapid diagnostic tests for malaria in an emergency situation after the flood disaster in Mozambique. Public Health 2006;120(5):444-7.
Hawkes 2009 {published data only}
  • Hawkes M, Katsuva JP, Masumbuko CK. Use and limitations of malaria rapid diagnostic testing by community health workers in war-torn Democratic Republic of Congo. Malaria Journal 2009;8:308.
Hernandes 2001 {published data only}
  • Hernandez E, De Pina JJ, Fabre R, Garrabe E, Raphenon G, Cavallo JD. Evaluation of the OptiMal test in the diagnosis of imported malarial outbreak. Médecine Tropicale 2001;61(2):153-7.
Holmberg 1992 {published data only}
  • Holmberg M, Wahlberg J, Lundeberg J, Pettersson U, Uhlén M. Colorimetric detection of Plasmodium falciparum and direct sequencing of amplified gene fragments using a solid phase method. Molecular and Cellular Probes 1992;6(3):201-8.
Hopkins 2007 {published data only}
  • Hopkins H, Kambale W, Kamya MR, Staedke SG, Dorsey G, Rosenthal PJ. Comparison of HRP2 and pLDH-based rapid diagnostic tests for malaria with longitudinal follow-up in Kampala, Uganda. American Journal of Tropical Medicine and Hygeine 2007;76(6):1092-7.
Hopkins 2008 {published data only}
  • Hopkins H, Bebell L, Kambales W, Dokomajilar C, Rosenthal PJ, Dorsey G. Rapid diagnostic tests for malaria at sites of varying transmission intensity in Uganda. Journal of Infectious Diseases 2008;197(4):510-8.
Hossain 2008 {published data only}
  • Hossain MA, Afroj S, Rahman MR, Yunus EB, Samad R, Asna ZH, et al. Evaluation of alternative diagnostic techniques for diagnosis of cerebral malaria in a tertiary referral hospital in Bangladesh. Mymensingh Medical Journal 2008;17(2):180-5.
Houmsou 2011 {published data only}
  • Houmsou RS, Amuta EU, Sar TT, Adagba AH. Malarial infection among patients attending a Nigerian semi-urban based hospital and performance of HRP-2 pf Rapid diagnostic Test (RDT) in screening clinical cases of Plasmodium falciparum malaria. Translational Biomedicine 2011;2:1.
Houzé 2009 {published data only}
  • Houzé S, Boly MD, Le Bras J, Deloron P, Faucher JF. PfHRP-2 and PfLDH antigen detection for monitoring the efficacy of artemisinin-based combination therapy (ACT) in the treatment of uncomplicated falciparum malaria. Malaria Journal 2009;8:211.
Houzé 2011 {published data only}
  • Houzé S, Hubert V, Cohen DP, Rivetz B, Le Bras J. Evaluation of the Clearview® Malaria pLDH Malaria Rapid Diagnostic Test in a non-endemic setting. Malaria Journal 2011;10:284.
Humar 1997 {published data only}
  • Humar A, Ohrt C, Harrington MA, Pillai D, Kain KC. Parasight F test compared with the polymerase chain reaction and microscopy for the diagnosis of Plasmodium falciparum malaria in travelers. American Journal of Tropical Medicine and Hygiene 1997;56(1):44-8.
Huong 2002 {published data only}
  • Huong NM, Davis TME, Hewitt S, Huong N, Uyen TT, Nhan DH, et al. Comparison of three antigen detection methods for diagnosis and therapeutic monitoring of malaria: a field study from southern Vietnam. Tropical Medicine and International Health 2002;7(4):304-8.
Iqbal 2000 {published data only}
  • Iqbal J, Sher A, Rab A. Plasmodium falciparum histidine-rich protein 2-based immunocapture diagnostic assay for malaria: cross-reactivity with rheumatoid factors. Journal of Clinical Microbiology 2000;38(3):1184-6.
Iqbal 2001 {published data only}
  • Iqbal J, Hira PR, Sher A, Al-Enezi AA. Diagnosis of imported malaria by Plasmodium lactate dehydrogenase (pLDH) and histidine-rich protein 2 (PfHRP-2)-based immunocapture assays. American Journal of Tropical Medicine and Hygiene 2001;64(1-2):20-3.
Iqbal 2002 {published data only}
  • Iqbal J, Khalid N, Hira PR. Comparison of two commercial assays with expert microscopy for confirmation of symptomatically diagnosed malaria. Journal of Clinical Microbiology 2002;40(12):4675-8.
Iqbal 2003 {published data only}
  • Iqbal J, Muneer A, Khalid N, Ahmed MA. Performance of the OptiMAL test for malaria diagnosis among suspected malaria patients at the rural health centres. American Journal of Tropical Medicine and Hygiene 2003;68(5):624-8.
Iqbal 2004 {published data only}
  • Iqbal J, Siddique A, Jameel M, Hira PR. Persistent histidine-rich protein 2, parasite lactate dehydrogenase, and panmalarial antigen reactivity after clearance of Plasmodium falciparum monoinfection. Journal of Clinical Microbiology 2004;42(9):4237-41.
Ishengoma 2011 {published data only}
  • Ishengoma DS, Francis F, Mmbando BP, Lusingu JP, Magistrado P, Alifrangis M, et al. Accuracy of malaria rapid diagnostic tests in community studies and their impact on treatment of malaria in an area with declining malaria burden in north-eastern Tanzania. Malaria Journal 2011;10:176.
Jang 2013 {published data only}
  • Jang JW, Cho CH, Han ET, An SS, Lim CS. pLDH level of clinically isolated Plasmodium vivax and detection limit of pLDH based malaria rapid diagnostic test. Malaria Journal 2013;12:181.
Jelinek 1996 {published data only}
  • Jelinek T, Kilian AH, Henk M, Mughusu EB, Nothdurft HD, Löscher T, et al. Parasite-specific lactate dehydrogenase for the diagnosis of Plasmodium falciparum infection in an endemic area in west Uganda. Tropical Medicine and International Health 1996;1(2):227-30.
Jelinek 1999 {published data only}
  • Jelinek T, Grobusch MP, Schwenke S, Steidl S, von Sonnenburg F, Nothdurft HD, et al. Sensitivity and specificity of dipstick tests for rapid diagnosis of malaria in nonimmune travelers. Journal of Clinical Microbiology 1999;37(3):721-3.
Jelinek 2000 {published data only}
Jelinek 2001 {published data only}
  • Jelinek T, Grobusch MP, Harms G. Evaluation of a dipstick test for the rapid diagnosis of imported malaria among patients presenting within the network TropNetEurop. Scandinavian Journal of Infectious Diseases 2001;33(10):752-4.
Jeurissen 1999 {published data only}
  • Jeurissen A, Beert J. Two rapid tests for the detection of Plasmodium falciparum. Tijdschrift voor Geneeskunde 1999;55:1088-92.
John 1998 {published data only}
Joshi 2004 {published data only}
  • Joshi HH, Mahakunkijcharoen Y, Tantivanich S, Sharma AP, Khusmith S. Detection of P. vivax antigens in malaria endemic populations of Nepal by ELISA using monoclonal antibodies raised against Thai isolates. Southeast Asian Journal of Tropical Medicine and Public Health 2004;35(4):828-33.
Kaewsonthi 1996 {published data only}
  • Kaewsonthi S, Harding AG, Kidson C, Indaratna K. Assessing the economic impact of a rapid on-site malaria diagnostic test. Southeast Asian Journal of Tropical Medicine and Public Health 1996;27(2):210-5.
Kahama-Maro 2008 {published data only}
  • Kahama-Maro J, D'Acremont V, Mtasiwa D, Genton B, Lengeler C. Low quality of routine microscopy for malaria at different health systems levels in Dar es Salaam: rapid diagnostic tests should also be implemented in hospitals and urban settings. American Journal of Tropical Medicine and Hygiene 2008;79(6):394.
Kahama-Maro 2011 {published data only}
  • Kahama-Maro J, D'Acremont V, Mtasiwa D, Genton B, Lengeler C. Low quality of routine microscopy for malaria at different levels of the health system in Dar es Salaam. Malaria Journal 2011;10:332.
Kakkilaya 2003 {published data only}
Kamugisha 2008 {published data only}
  • Kamugisha ML, Msangeni H, Beale E, Malecela EK, Akida JI, Ishengoma DR, et al. Paracheck Pf compared with microscopy for diagnosis of Plasmodium falciparum malaria among children in Tanga City, north-eastern Tanzania. Tanzania Journal of Health Research 2008;10(1):14-9.
Kar 1998 {published data only}
  • Kar I, Eapen A, Adak T, Sharma VP. Trial with ParaSight-F in the detection of Plasmodium falciparum infection in Chennai (Tamil Nadu) India. Indian Journal of Malariology 1998;35(3):160-2.
Karbwang 1996 {published data only}
  • Karbwang J, Tasanor O, Kanda T, Wattanagoon Y, Ibrahim M, Na-Bangchang K, et al. ParaSight-F test for the detection of treatment failure in multidrug resistant Plasmodium falciparum malaria. Transactions of the Royal Society of Tropical Medicine and Hygiene 1996;90(5):513-5.
Karimov 2011 {published data only}
  • Karimov SS, Baranova AM, Saĭburkhonov DS. [Evaluation of the efficiency of rapid tests to detect malaria patients and parasite carriers in Tajikistan]. Meditsinskaia Parazitologiia i Parazitarnye Bolezni 2011;3:46-7.
Kashif 2013 {published data only}
  • Kashif AH, Adam GK, Mohmmed AA, Elzaki SE, AbdelHalim AM, Adam I. Reliability of rapid diagnostic test for diagnosing peripheral and placental malaria in an area of unstable malaria transmission in Eastern Sudan. Diagnostic Pathology 2013;8:59.
Katakai 2011 {published data only}
  • Katakai Y, Komaki-Yasuda K, Tangpukdee N, Wilairatana P, Krudsood S, Kano S. Evaluation of the NOW malaria immunochromatographic test for quantitative diagnosis of falciparum and vivax malaria parasite density. Tropical Medicine and Health 2011;39(4):105-8.
Kattenberg 2011 {published data only}
  • Kattenberg J, Tahita M, Taal A, Zoeten J, Versteeg I, Tinto H, et al. Antigen persistence of rapid diagnostic tests and its implications for the diagnosis of malaria in pregnancy. An evaluation in Nanoro, Burkina Faso. 7th European Congress on Tropical Medicine and International Health; 2011 03-06 Oct; Barcelona. Tropical Medicine and International Health. 2011:138-9.
Kaur 2000 {published data only}
  • Kaur H, Mani A. Evaluation & usefulness of a immunochromatographic test for rapid detection of Plasmodium falciparum infection. Indian Journal of Medical Sciences 2000;54(10):421-4.
Kaushal 1995 {published data only}
  • Kaushal DC, Kaushal N, Chandra D, Palni R. Immunodiagnosis of malaria based on detection of parasite enzyme. Journal of Parasitic Diseases 1995;19:21-4.
Kaushal 1997 {published data only}
  • Kaushal DC, Kaushal NA. Immunodiagnosis of malaria. Journal of Parasitic Diseases 1997;21(1):31-40.
Kawai 2009 {published data only}
  • Kawai S, Hirai M, Haruki K, Tanabe K, Chigusa Y. Cross-reactivity in rapid diagnostic tests between human malaria and zoonotic simian malaria parasite Plasmodium knowlesi infections. Parasitology International 2009;58(3):300-2.
Keating 2009 {published data only}
  • Keating J, Miller JM, Bennett A, Moonga HB, Eisele TP. Plasmodium falciparum parasite infection prevalence from a household survey in Zambia using microscopy and a rapid diagnostic test: implications for monitoring and evaluation. Acta Tropica 2009;112(3):277-82.
Khairnar 2009 {published data only}
  • Khairnar K, Martin D, Lau R, Ralevski F, Pillai DR. Multiplex real-time quantitative PCR, microscopy and rapid diagnostic immuno-chromatographic tests for the detection of Plasmodium spp: performance, limit of detection analysis and quality assurance. Malaria Journal 2009;8:284.
Khan 2004 {published data only}
  • Khan SA, Anwar M, Hussain S, Qureshi AH, Ahmad A, Afzal S. Comparison of OptiMAL malarial test with light microscopy for the diagnosis of malaria. Journal of the Pakistan Medical Association 2004;54(8):404-7.
Kilian 1997 {published data only}
  • Kilian AHD, Mughusu EB, Kabagambe G, von Sonnenburg F. Comparison of two rapid, HRP-2-based diagnostic tests for Plasmodium falciparum. Transactions of the Royal Society of Tropical Medicine and Hygiene 1997;91(6):666-7.
Kilian 1999 {published data only}
  • Kilian AHD, Kabagambe G, Byamukama W, Langi P, Weis P, von Sonnenburg F. Application of the ParaSight-F dipstick test for malaria diagnosis in a district control programme. Acta Tropica 1999;72(3):281-93.
Kim 2008 {published data only}
Kim 2011 {published data only}
Kim 2013 {published data only}
  • Kim JY, Ji SY, Goo YK, Na BK, Pyo HJ, Lee HN, et al. Comparison of rapid diagnostic tests for the detection of Plasmodium vivax malaria in South Korea. PLoS One 2013;8(5):e64353.
Knappik 2002 {published data only}
  • Knappik M, Peyerl-Hoffmann G, Jelinek T. Plasmodium falciparum: use of a NANP19 antibody-test for the detection of infection in non-immune travellers. Tropical Medicine and International Health 7;8:652-6.
Kodisinghe 1997 {published data only}
  • Kodisinghe HM, Perera KL, Premawansa S, Naotunne T, Wickramasinghe AR, Mendis KN. The ParaSight-F dipstick test as a routine diagnostic tool for malaria in Sri Lanka. Transactions of the Royal Society of Tropical Medicine and Hygiene 1997;91(4):398-402.
Koita 2012 {published data only}
  • Koita OA, Doumbo OK, Ouattara A, Tall LK, Konaré A, Diakité M, et al. False-negative rapid diagnostic tests for malaria and deletion of the histidine-rich repeat region of the hrp2 gene. American Journal of Tropical Medicine and Hygiene 2012;86(2):194-8.
Kumar 1996 {published data only}
  • Kumar A, Sharma VP, Thavaselvam D, Sumodan PK. Clinical trials of a new immunochromatographic test for diagnosis of Plasmodium falciparum malaria in Goa. Indian Journal of Malariology 1996;33(4):166-72.
Kumar 2000 {published data only}
  • Kumar A, Sumodan PK, Sharma VP. Clinical trials of an indigenous diagnostic kit Paracheck-F for the diagnosis of Plasmodium falciparum malaria in Goa. Journal of Parasitic Diseases 2000;24:43-5.
Kumar 2004 {published data only}
  • Kumar KR, Sudarshan KS. Clinical evaluation of a rapid diagnostic kit (Paracheck-Pf) for diagnosis of Plasmodium falciparum in Karnataka state of India. Indian Journal of Preventive and Social Medicine 2004;35(1):10-4.
Kumar 2012 {published data only}
  • Kumar N, Singh JPN, Pande V, Mishra N, Srivastava B, Kapoor R, et al. Genetic variation in histidine rich proteins among Indian Plasmodium falciparum population: possible cause of variable sensitivity of malaria rapid diagnostic tests. Malaria Journal 2012;11:298.
Kumar 2013 {published data only}
  • Kumar N, Pande V, Bhatt RM, Shah NK, Mishra N, Srivastava B, et al. Genetic deletion of HRP2 and HRP3 in Indian Plasmodium falciparum population and false negative malaria rapid diagnostic test. Acta Tropica 2013;125(1):119-21.
Kweka 2011 {published data only}
  • Kweka EJ, Lowassa A, Msangi S, Kimaro EE, Lyatuu EE, Mwang'onde BJ, et al. Low sensitivity of paraHIT-F rapid malaria test among patients with fever in rural health centers, Northern Tanzania. Journal of Infection in Developing Countries 2011;5(3):204-8.
Kyabayinze 2008 {published data only}
  • Kyabayinze DJ. Field validity and comparative persistent antigenicity of HRP-2 rapid diagnostic tests for malaria in a hyperendemic region of Uganda. American Journal of Tropical Medicine and Hygiene 2008;79(6):884.
  • Kyabayinze DJ, Tibenderana JK, Odong GW, Rwakimari JB, Counihan H. Operational accuracy and comparative persistent antigenicity of HRP2 rapid diagnostic tests for Plasmodium falciparum malaria in a hyperendemic region of Uganda. Malaria Journal 2008;7:221.
Labbé 2001 {published data only}
  • Labbé AC, Pillai DR, Hongvangthong B, Vanisaveth V, Pomphida S, Inkathone S, et al. The performance and utility of rapid diagnostic assays for Plasmodium falciparum malaria in a field setting in the Lao People's Democratic Republic. Annals of Tropical Medicine and Parasitology 95;7:671-7.
Lee 1999 {published data only}
  • Lee MA, Aw LT, Singh M. A comparison of antigen dipstick assays with polymerase chain reaction (PCR) technique and blood film examination in the rapid diagnosis of malaria. Annal of the Academy of Medicine of Singapore 1999;28(4):498-501.
Lee 2008 {published data only}
  • Lee SW, Jeon K, Jeon BR, Park I. Rapid diagnosis of vivax malaria by the SD Bioline Malaria Antigen test when thrombocytopenia is present. Journal of Clinical Microbiology 2008;46(3):939-42.
Lee 2011 {published data only}
  • Lee GC, Jeon ES, Le DT, Kim TS, Yoo JH, Kim HY, et al. Development and evaluation of a rapid diagnostic test for Plasmodium falciparum, P. vivax, and mixed-species malaria antigens. American Journal of Tropical Medicine and Hygiene 2011;85(6):989-93.
Lema 1999 {published data only}
  • Lema OE, Carter JY, Nagelkerke N, Wangai MW, Kitenge P, Gikunda SM, et al. Comparison of five methods of malaria detection in the outpatient setting. American Journal of Tropical Medicine and Hygiene 1999;60(2):177-82.
Lepère 2004 {published data only}
  • Lepère JF, Macarry A. Malaria diagnosis and treatment in a rural Health Centre in Mayotte (Comoro archipelago, 2002). Santé 2004;14(1):5-10.
Lim 2001 {published data only}
Llanos Zavalaga 2000 {published data only}
  • Llanos Zavalaga LF, Huayta Zacarías E, Mendoza Requena D, Rosas Aguirre A, Contreras Ríos C, Peinada Rodríguez J. Knowledge and perceptions of health workers in malaria endemic areas in Peru on the rapid test Parasight-F [Conocimientos y percepciones de los trabajadores de salud de zona endémica de malaria en el Perú sobre la prueba de diagnóstico rápido ParaSight-F]. Revista Medica Herediana 2000;11(4):115-21.
Llanos-Zavalaga 2002 {published data only}
  • Llanos-Zavalaga LF, Villacorta JV, Reyes RL, Lecca LG, Mendoza DR, Mayca JP, et al. Evaluation of the ICT Test Malaria P.f/P.v (AMRAD®) for the detection of P. falciparum and P. vivax malaria in an endemic area of the Peruvian Amazon [Evaluación de la prueba ICT Malaria P.f/P.v (AMRAD®) para la detección de P. falciparum y P. vivax en una zona endémica de la Amazonía peruana]. Revista Peruana de Medicina Experimental y Salud Publica 2002;19(1):39-42.
Mahajan 2000 {published data only}
  • Mahajan SK, Siwach SR, Kishore K, Chaudhry D, Sen R, Aggarwal HK, et al. Evaluation of a rapid dipstick antigen capture assay for the diagnosis of falciparum malaria. Indian Practitioner 2009;53(5):325-9.
Makler 1998 {published data only}
Makler 2009 {published data only}
Malik 2004 {published data only}
  • Malik S, Khan S, Das A, Samantaray JC. Plasmodium lactate dehydrogenase assay to detect malarial parasites. National Medical Journal of India 2004;17(5):237-9.
Mankhambo 2002 {published data only}
  • Mankhambo L, Kanjala M, Rudman S, Lema VM, Rogerson SJ. Evaluation of the OptiMAL rapid antigen test and species-specific PCR to detect placental Plasmodium falciparum infection at delivery. Journal of Clinical Microbiology 2002;40(1):155-8.
Mason 2002 {published data only}
  • Mason DP, Kawamoto F, Lin K, Laoboonchai A, Wongsrichanalai C. A comparison of two rapid field immunochromatographic tests to expert microscopy in the diagnosis of malaria. Acta Tropica 2002;82(1):51-9.
Mawili-Mboumba 2010 {published data only}
  • Mawili-Mboumba DP, Bouyou Akotet MK, Ngoungou EB, Kombila M. Evaluation of rapid diagnostic tests for malaria case management in Gabon. Diagnostic Microbiology and Infectious Disease 2010;66(2):162-8.
Mayxay 2004 {published data only}
  • Mayxay M, Newton PN, Yeung S, Pongvongsa T, Phompida S, Phetsouvanh T, et al. Short communication: An assessment of the use of malaria rapid tests by village health volunteers in rural Laos. Tropical Medicine and International Health 2004;9(3):325-9.
Mboera 2006a {published data only}
  • Mboera LEG, Fanello CI, Malima RC, Talbert A, Fogliati P, Bobbio F, et al. Comparison of the Paracheck-Pf test with microscopy, for the confirmation of Plasmodium falciparum malaria in Tanzania. Annals of Tropical Medicine and Parasitology 2006;100(2):115-22.
McCutchan 2008 {published data only}
McMorrow 2010 {published data only}
  • McMorrow ML, Masanja MI, Kahigwa E, Abdullah SMK, Kachur SP. Quality assurance of rapid diagnostic tests for malaria in routine patient care in rural Tanzania. American Journal of Tropical Medicine and Hygiene 2010;82(1):151-5.
Meena 2009 {published data only}
  • Meena M, Joshi D, Joshi R, Sridhar S, Waghdhare S, Gangane N, et al. Accuracy of a multispecies rapid diagnostic test kit for detection of malarial parasite at the point of care in a low endemicity region. Transactions of the Royal Society of Tropical Medicine and Hygeine 2009;103(12):1237-44.
Menan 1996 {published data only}
  • Menan EIH, Adou-Bryn KD, Mobio SP, Cisse M, Penali K, Kone M. Assessment of parasitological examinations of blood for malaria at the Pasteur Institute Côte d'Ivoire (IPCI) in 1992: the impact of chemotherapy on the laboratory results [Bilan des examens parasitologiques du sang pour la recherche du paludisme a l'Institut Pasteur de Côte d'Ivoire (I.P.C.I) en 1992: impact de la chimiotherapie sur les resultats de laboratoire]. Medecine d'Afrique Noire 1996;43(3):129-33.
Mendiratta 2006 {published data only}
  • Mendiratta DK, Bhutada K, Narang R, Narang P. Evaluation of different methods for diagnosis of P. falciparum malaria. Indian Journal of Medical Microbiology 2006;24(1):49-51.
Mendoza 2007 {published data only}
  • Mendoza NM, García M, Cortés LJ, Vela C, Erazo R, Pérez P, et al. Evaluation of two rapid diagnostic tests, NOW ICT Malaria Pf/Pv and OptiMAL, for diagnosis of malaria. Biomedica 2007;27(4):571-80.
Mendoza 2013 {published data only}
  • Mendoza NM, Cucunuba ZM, Aponte S, Gonzalez NE, Bernal SD. [Field evaluation for diagnostic accuracy of the rapid test SD Bioline Malaria Antigen Pf/Pv(R) in Colombia]. Biomedica 2013;33(4):587-597.
Mengesha 1999 {published data only}
  • Mengesha T, Gebreselassie H, Mohammed T, Assefa T, Woldemichael T. ParaSight-F dipstick antigen tests in the diagnosis of falciparum malaria in Ethiopia. East African Medical Journal 1999;76(11):626-9.
Mens 2007 {published data only}
  • Mens P, Spieker N, Omar S, Heijnen M, Schallig H, Kager PA. Is molecular biology the best alternative for diagnosis of malaria to microscopy? A comparison between microscopy, antigen detection and molecular tests in rural Kenya and urban Tanzania. Tropical Medicine and International Health 2007;12(2):238-44.
Mens 2010 {published data only}
  • Mens PF, Matelon RJ, Nour BYM, Newman DM, Schallig HDFH. Laboratory evaluation on the sensitivity and specificity of a novel rapid detection method for malaria diagnosis based on magneto-optical technology (MOT). Malaria Journal 2010;9:207.
Metzger 2008 {published data only}
  • Metzger WG, Vivas-Martínez S, Rodriguez I, Gonçalves J, Bongard E, Fanello CI, et al. Malaria diagnosis under field conditions in the Venezuelan Amazon. Transactions of the Royal Society of Tropical Medicine and Hygiene 2008;102(1):20-4.
Metzger 2009 {published data only}
Mharakurwa 1997a {published data only}
  • Mharakurwa S, Shiff CJ. Post treatment sensitivity studies with the ParaSight-F test for malaria diagnosis in Zimbabwe. Tropical Medicine and International Health 1997;66(2):61-7.
Mharakurwa 1997b {published data only}
Miantuasila 2012 {published data only}
  • Miantuasila O. Comparison between molecular and conventional diagnostic tools for the diagnosis of malaria and sickle cell gene carriage. 6th EDCTP Forum: Strengthening Research Partnerships for Better Health and Sustainable Development; 2011 09-12 October; Addis Ababa. Tropical Medicine and International Health. 2012:57-8.
Mikhail 2011 {published data only}
  • Mikhail AF, Leslie TJ, Mayan MI, Zekria R, Mohammad N, Hasanzai MA, et al. Field trial of three different Plasmodium vivax-detecting rapid diagnostic tests with and without evaporative cool box storage in Afghanistan. Malaria Journal 2011;10:169.
Miller 2001 {published data only}
Miller 2008 {published data only}
  • Miller RS. Comparison of performance characteristics of the Binax NOW Malaria test using venous and fingerstick samples. American Journal of Tropical Medicine and Hygiene 2008;79(6):533.
Mills 1999 {published data only}
  • Mills CD, Burgess DC, Taylor HJ, Kain KC. Evaluation of a rapid and inexpensive dipstick assay for the diagnosis of Plasmodium falciparum malaria. Bulletin of the World Health Organization 1999;77(7):553-9.
Mills 2007 {published data only}
  • Mills LA, Blank LR, Kagaayi J, Aluma S, Shott J, Bwanika JB, et al. Performance of malaria rapid diagnostic test versus traditional microscopy among rural Ugandan outpatients. American Journal of Tropical Medicine and Hygiene 2007;75(5):96.
Mills 2010 {published data only}
  • Mills LA, Kagaayi J, Nakigozi G, Galiwango RM, Ouma J, Shott JP, et al. Short report: Utility of a point-of-care malaria rapid diagnostic for excluding malaria as the cause of fever among HIV-positive adults in rural Rakai, Uganda. American Journal of Tropical Medicine and Hygiene 2010;82(1):145-7.
Mills 2010a {published data only}
  • Mills LA, Kagaayi J, Shott JP, Newell K, Bwanika JB, Ssempijja V, et al. Performance of prototype malaria rapid diagnostic test versus thick film microscopy among HIV-postive subjects in rural Rakai, Uganda. Transactions of the Royal Society of Tropical Medicine in Hygiene 2010;104(3):237-9.
Minja 2012 {published data only}
  • Minja DT, Schmiegelow C, Oesterholt M, Magistrado PA, Boström S, John D, et al. Reliability of rapid diagnostic tests in diagnosing pregnancy-associated malaria in north-eastern Tanzania. Malaria Journal 2012;11:211.
Minodier 2005 {published data only}
  • Minodier P. Malaria diagnosis: rapid detection tests. Clinical Microbiology Reviews 2005;18(8):386-8.
  • Minodier P, Noël G, Blanc P, Retornaz K, Garnier JM. Tests for rapid diagnosis of malaria. Archives de Pediatrie 2005;12(6):697-9.
Mishra 1999 {published data only}
  • Mishra B, Samantaray J C, Mirdha BR. Evaluation of a rapid antigen capture assay for the diagnosis of falciparum malaria. Indian Journal of Medical Research 1999;109:16-9.
Mishra 2007 {published data only}
  • Mishra MN, Misra RN. Immunochromatographic methods in malaria diagnosis. Medical Journal Armed Forces India 2007;63(2):127-9.
Mohanty 1999 {published data only}
  • Mohanty S, Mishra SK, Mohanty A, Das BS. Immunochromatographic test for the diagnosis of falciparum malaria. Journal of the Association of Physicians of India 1999;47(2):201-2.
Mohapatra 1996 {published data only}
  • Mohapatra PK, Prakash A, Khan AM, Bhattacharyya DR, Goswami BK, Mahanta J. Evaluation of a manual immunochromatographic test for detection of Plasmodium falciparum HRP-2 antigen. Indian Journal of Medical Microbiology 1996;14(4):193-5.
Montoya 2008 {published data only}
  • Montoya AE, Menco J, Osorio N, Zuluaga MA, Duque J, Torres G, et al. Concordance between thick blood smear, immunochromatography and polymerase chain reaction for malaria diagnosis. Biomedica 2008;28(2):252-61.
Moody 2000 {published data only}
  • Moody A, Hunt-Cooke A, Gabbett E, Chiodini P. Performance of the OptiMAL malaria antigen capture dipstick for malaria diagnosis and treatment monitoring at the Hospital for Tropical Diseases, London. British Journal of Haematology 2000;109(4):891-4.
Moody 2002a {published data only}
Moody 2002b {published data only}
  • Moody AH, Chiodini PL. Non-microscopic method for malaria diagnosis using OptiMAL IT, a second-generation dipstick for malaria pLDH antigen detection. British Journal of Biomedical Science 2002;59(4):228-31.
Moonasar 2007 {published data only}
  • Moonasar D, Goga AE, Frean J, Kruger P, Chandramohan D. An exploratory study of factors that affect the performance and usage of rapid diagnostic tests for malaria in the Limpopo Province, South Africa. Malaria Journal 2007;6:74.
Moonasar 2009 {published data only}
  • Moonasar D, Goga AE, Kruger PS, La Cock C, Maharaj R, Frean J, et al. Field evaluation of a malaria rapid diagnostic test (ICT Pf). South African Medical Journal 2009;99(11):810-3.
Morankar 2011 {published data only}
  • Morankar S, Tegene A, Kassahun W, Sulueiman S, Negatu YA, Yazachew M, et al. Validity and reliability of RDT for diagnosis of malaria among febrile children in Jimma Town: southwest Ethiopia. Ethiopian Medical Journal 2011;49(2):131-8.
Moulin 2009 {published data only}
Msellem 2009 {published data only}
  • Msellem MI, Mårtensson A, Rotllant G, Bhattarai A, Strömberg J, Kahigwa E, et al. Influence of rapid malaria diagnostic tests on treatment and health outcome in fever patients, Zanzibar: a crossover validation study. PLoS Medicine 2009;6(4):e1000070.
Mtove 2011 {published data only}
  • Mtove G, Hendriksen ICE, Amos B, Mrema H, Mandia V, Manjurano A, et al. Treatment guided by rapid diagnostic tests for malaria in Tanzanian children: safety and alternative bacterial diagnoses. Malaria Journal 2011;10:290.
Mueller 2007 {published data only}
  • Mueller I, Betuela I, Ginny M, Reeder JC, Genton B. The sensitivity of the OptiMAL rapid diagnostic test to the presence of Plasmodium falciparum gametocytes compromises its ability to monitor treatment outcomes in an area of Papua New Guinea in which malaria is endemic. Journal of Clinical Microbiology 2007;45(2):627-30.
Muhindo 2012 {published data only}
  • Muhindo HM, Ilombe G, Meya R, Mitashi PM, Kutekemeni A, Gasigwa D, et al. Accuracy of malaria rapid diagnosis test Optimal-IT(®) in Kinshasa, the Democratic Republic of Congo. Malaria Journal 2012;11:224.
Munier 2009 {published data only}
  • Munier A, Diallo A, Sokhna C, Chippaux JP. Assessment of a rapid diagnostic test for malaria in rural health care facilities in Senegal. Medicine Tropicale 2009;69(5):496-500.
Murahwa 1999 {published data only}
  • Murahwa FC, Mharakurwa S, Mutambu SL, Rangarira R, Musana BJ. Diagnostic performance of two antigen capture tests for the diagnosis of Plasmodium falciparum malaria in Zimbabwe. Central African Journal of Medicine 1999;45(4):97-100.
Murray 2003 {published data only}
Murray 2008 {published data only}
Mwanza 2005 {published data only}
  • Mwanza S, Njunju E, Mbewe B, Chileshe N, Mataa N, Kalungwana N. Evaluation of the hexagon malaria rapid diagnostic test kit in five communities on the copperbelt province of Zambia. Acta Tropica 2005;95S:S303-4.
Myjak 2004 {published data only}
  • Myjak P, Nahorski W, Zarnowska-Prymek H, Pietkiewicz H. Usefulness of the "OptiMAL Rapid Malaria test" for rapid detection of malaria imported to Poland. Wiadomości Parazytologiczne 2004;50(2):193-9.
Naing 2002a {published data only}
  • Cho-Min-Naing, Gatton ML. Performance appraisal of rapid on-site malaria diagnosis (ICT Malaria Pf/Pv test) in relation to human resources at village level Myanmar. Acta Tropica 2002;81(1):13-9.
Nema 2005 {published data only}
  • Nema SK, Chopra GS, Gupta RM, Rai R, Diwan RN. Diagnosis of malaria infection using non-radioactive malaria diagnostic system (NOMADS). Medical Journal Armed Forces India 2005;61(4):336-9.
Neumann 2008 {published data only}
  • Neumann CG, Bwibo NO, Siekmann JH, McLean ED, Browdy B, Drorbaugh N. Comparison of blood smear microscopy to a rapid diagnostic test for in-vitro testing for P. falciparum malaria in Kenyan school children. East African Medical Journal 2008;85(11):544-9.
Nicastri 2009a {published data only}
  • Nicastri E, Bevilacqua N, Sañé Schepisi SM, Paglia MG, Meschi S, Ame SM, et al. Accuracy of malaria diagnosis by microscopy, rapid diagnostic test, and PCR methods and evidence of antimalarial overprescription in non-severe febrile patients in two Tanzanian hospitals. American Journal of Tropical Medicine and Hygiene 2009;80(5):712-7.
Nigussie 2008 {published data only}
  • Nigussie D, Legesse M, Animut A, Mariam AH, Mulu A. Evaluation of Paracheck Pf and Parascreen Pan/Pf tests for the diagnosis of malaria in an endemic area, South Ethiopia. Ethiopian Medical Journal 2008;46(4):375-81.
Nkrumah 2010 {published data only}
  • Nkrumah B, Agyekum A, Acquah SEK, May J, Tannich E, Brattig N, et al. Comparison of the novel Partec rapid diagnostic test to the conventional giemsa stain and the gold standard real-time PCR. Journal of Clinical Microbiology 2010;48(8):2925-8.
Nkrumah 2011 {published data only}
  • Nkrumah B, Acquah SE, Ibrahim L, May J, Brattig N, Tannich E, et al. Comparative evaluation of two rapid field tests for malaria diagnosis: Partec Rapid Malaria Test® and Binax Now® Malaria Rapid Diagnostic Test. BMC Infectious Diseases 2011;11:143.
Nour 2011 {published data only}
  • Nour B. Using RDTS as a malaria diagnostic tool in wad Medani different hospitals - Central Sudan. 7th European Congress on Tropical Medicine and International Health; 2011 03-06 Oct; Barcelona. Tropical Medicine and International Health. 2011:149.
Nwuba 2001 {published data only}
  • Nwuba RI, Anumuda CI, Omosun YO, Sodeinde O, Nwagwu M. Evaluation of a rapid immunochromatographic card test for Plasmodium falciparum in Ibadan, Nigeria. African Journal of Medical Science 2001;30(1-2):123-4.
Nyunt 2013 {published data only}
  • Nyunt MH, Kyaw MP, Win KK, Myint KM, Nyunt KM. Field evaluation of HRP2 and pan pLDH-based immunochromatographic assay in therapeutic monitoring of uncomplicated falciparum malaria in Myanmar. Malaria Journal 2013;12:123.
Ochola 2006 {published data only}
  • Ochola LB, Vounatsou P, Smith T, Mabaso MLH, Newton CRJC. The reliability of diagnostic techniques in the diagnosis and management of malaria in the absence of a gold standard. Lancet Infectious Diseases 2006;6(9):582-8.
Omar 1999 {published data only}
  • Omar MS, Malik GM, Al-Amari OM, Abdalla SE, Moosa RA. The rapid manual ParaSight-F test for diagnosing Plasmodium falciparum malaria in Saudi Arabia. Annals of Saudi Medicine 1999;19(2):159-62.
OMS 1999 {published data only}
  • Organisation Mondiale de la Sante USAID. Directive pour l'evaluation rapide: reconnaissance des symptomes de maladies pour le paludisme grave et complique. OMS/TDR/USAID, 1999.
Onile 2005 {published data only}
  • Onile B, Taiwo S. Recent advances in the laboratory diagnosis of malaria. African Journal of Clinical and Experimental Microbiology 2005;6(2):113-23.
Osman 2010 {published data only}
  • Osman MMM, Nour BYM, Sedig MF, De Bes L, Babikir AM, Mohamedani AA, et al. Informed decision-making before changing to RDT: a comparison of microscopy, rapid diagnostic test and molecular techniques for the diagnosis and identification of malaria parasites in Kassala, eastern Sudan. Tropical Medicine and International Health 2010;15(12):1442-8.
Ouattara 2011 {published data only}
  • Ouattara A, Doumbo S, Saye R, Beavogui AH, Traoré B, Djimdé A, et al. Use of a pLDH-based dipstick in the diagnostic and therapeutic follow-up of malaria patients in Mali. Malaria Journal 2011;10:345.
Ozbilge 2006 {published data only}
  • Ozbilge H, Kurcer MA, Dogan N, Zeyrek F. Comparison with Pan Malaria IgG assays for malaria diagnosis and direct microscopy among suspected malaria patients in Sanliurfa. Tropical Doctor 2006;36(1):25-6.
Pabon 2007 {published data only}
  • Pabón A, Alvarez G, Yánez J, Céspedes C, Rodríguez Y, Restrepo A, et al. Evaluation of ICT malaria immunochromatographic Binax NOW® ICT P.f/P.v test for rapid diagnosis of malaria in a Colombian endemic area. Biomedica 2007;27(2):225-35.
Pakalapati 2013 {published data only}
  • Pakalapati D, Garg S, Middha S, Kochar A, Subudhi AK, Arunachalam BP, et al. Comparative evaluation of microscopy, OptiMAL® and 18S rRNA gene based multiplex PCR for detection of Plasmodium falciparum & Plasmodium vivax from field isolates of Bikaner, India. Asian Pacific Journal of Tropical Medicine 2013;6(5):346-51.
Palmer 1998 {published data only}
  • Palmer CJ, Lindon JF, Klaskala WI, Quesada JA, Kaminsky R, Baum MK, et al. Evaluation of the OptiMAL test for rapid diagnosis of Plasmodium vivax and Plasmodium falciparum malaria. Journal of Clinical Microbiology 1998;36(1):203-6.
Palmer 1999 {published data only}
  • Palmer CJ, Validum L, Lindo J, Campa A, Validum C, Makler M, et al. Field evaluation of OptiMAL rapid malaria diagnostic test during anti-malarial therapy in Guyana. Transactions of the Royal Society of Tropical Medicine and Hygiene 1999;93(5):517-8.
Palmer 2003 {published data only}
  • Palmer CJ, Bonilla JA, Bruckner DA, Barnett ED, Miller NS, Haseeb MA, et al. Multicenter study to evaluate the OptiMAL test for rapid diagnosis of malaria in U.S hospitals. Journal of Clinical Microbiology 2003;41(11):5178-82.
Pammenter 1988 {published data only}
Pandey 1995 {published data only}
  • Pandey J, Talib VH, Ranga S, Gulati IRA, Pandey J, Ranga S. Diagnosis of malaria: an overview. Journal of Parasitic Diseases 1995;19(1):21-4.
Pandya 2001 {published data only}
  • Pandya AP, Sahu GC, Anjan JK. The Para Check-PC Test: - a simple rapid dip stick test to detect Plasmodium falciparum infection. Journal of Communicable Diseases 2001;33(3):224-5.
Park 2003 {published data only}
  • Park SK, Lee KW, Hong SH, Kim DS, Lee JH, Jeon BH, et al. Development and evaluation of an immunochromatographic kit for the detection of antibody to Plasmodium vivax infection in South Korea. Yonsei Medical Journal 2003;44(4):747-50.
Park 2006 {published data only}
  • Park TS, Kim JH, Kang CI, Lee BH, Jeon BR, Lee SM, at al. Diagnostic usefulness of SD malaria antigen and antibody kits for differential diagnosis of vivax malaria in patients with fever of unknown origin. Korean Journal of Laboratory Medicine 2006;26(4):241-5.
Parra 1991 {published data only}
  • Parra ME, Evans CB, Taylor DW. Identification of Plasmodium falciparum histidine-rich protein 2 in the plasma of humans with malaria. Journal of Clinical Microbiology 1991;29(8):1629-34.
Peng 2012 {published data only}
  • Peng YP, Wu JL, Wang JH, Li WM, Yu SJ. Study and evaluation of Wondfo rapid diagnostic kit based on nano-gold immunochromatography assay for diagnosis of Plasmodium falciparum. Parasitology Research 2012;110(4):1421-5.
Penhalbel 2005 {published data only}
  • Penhalbel Rde S, Fugikaha E, Lorenzetti A, Alves RT, Cavasini CE, Rossit ARB, et al. Evaluation of an immunochromatography test for malaria diagnosis under different storage conditions. Revista de Sociedad Brasileira de Medicina Tropical 2005;38(2):194-5.
Pérez 2007 {published data only}
  • Pérez H, Bracho C, De La Rosa M. Malaria and rapid diagnostic tests [El paludismo y las pruebas rápidas de diagnóstico]. Boletín de Malariología y Salud Ambiental 2007;47(1):3-13.
Peyron 1999 {published data only}
  • Peyron F. Parasitological diagnosis of malaria: Routine and new laboratory techniques. Médecine et Maladies Infectieuses 1999;29(Suppl 3):295-301.
Phommanivong 2010 {published data only}
  • Phommanivong V, Thongkham K, Deyer G, Rene JP, Barennes H. An assessment of early diagnosis and treatment of malaria by village health volunteers in the Lao PDR. Malaria Journal 2010;9:347.
Pica 2005 {published data only}
  • Pica R, Castellano C. Looking for parasitic infection and disease: the Plasmodium falciparum malaria model. Clinica Terapeutica 2005;156(3):131-4.
Pieroni 1998 {published data only}
  • Pieroni P, Mills CD, Ohrt C, Harrington MA, Kain KC. Comparison of the ParaSight-F test and the ICT Malaria Pf test with the polymerase chain reaction for the diagnosis of Plasmodium falciparum malaria in travellers. Transactions of the Royal Society of Tropical Medicine and Hygiene 1998;92(2):166-9.
Pinto 1999 {published data only}
  • Pinto MJW, Pereira NF, Rodrigues S, Kharangate NV, Verenkar MP. Rapid diagnosis of falciparum malaria by detection of Plasmodium falciparum HRP-2 antigen. Journal of the Association of Physicians of India 1999;47(11):1076-8.
Piper 1999 {published data only}
  • Piper R, Lebras J, Wentworth L, Hunt-Cooke A, Houzé S, Chiodini P, et al. Immunocapture diagnostic assays for malaria using Plasmodium lactate dehydrogenase (pLDH). American Journal of Tropical Medicine and Hygiene 1999;60(1):109-18.
Pividal 1994 {published data only}
  • Pividal J, Monjane AL, Gomes A, Street E, Barreto A. Evaluation and selection of diagnostic techniques in direct malaria [Avaliacao e seleccao de tecnicas de diagnostico directo na malaria]. Revista Medica de Mocambique 1994;5(3):27-32.
Planche 2001 {published data only}
  • Planche T, Krishna S, Kombila M, Engel K, Faucher JF, Ngou-Milama E, et al. Comparison of methods for the rapid laboratory assessment of children with malaria. American Journal of Tropical Medicine and Hygiene 2001;65(5):599-602.
Playford 2002 {published data only}
  • Playford EG, Walker J. Evaluation of the ICT malaria P.f/P.v and the OptiMal rapid diagnostic tests for malaria in febrile returned travellers. Journal of Clinical Microbiology 2002;40(11):4166-71.
Popov 2000 {published data only}
  • Popov AF, Popova NI. Rapid methods for the diagnosis of tropical malaria. Meditsinskaia Parazitologiia i Parazitarnye Bolezni 2000;2:38-9.
Popov 2004 {published data only}
  • Popov AF, Nikiforov ND, Ivanis VA, Barkun SP, Sanin BI, Fed'kina LI. Diagnosis of malaria by express methods. Klinicheskaia Laboratornaia Diagnosis 2004;1:46-8.
Premji 1994 {published data only}
  • Premji Z, Minjas J N, Shiff CJ. Laboratory diagnosis of malaria by village health workers using the rapid manual ParaSight-F test. Transactions of the Royal Society of Tropical Medicine and Hygiene 1994;88(4):418.
Prou 1988 {published data only}
  • Prou O, Deletoille P. Rapid detection of Plasmodium falciparum antigens by monofluo Kit Plasmodium falciparum. Médecine et Maladies Infectieuses 1988;18(2):75-9.
Proux 2001 {published data only}
Quintana 1998 {published data only}
  • Quintana M, Piper R, Boling HL, Makler M, Sherman C, Gill E, et al. Malaria diagnosis by dipstick assay in a Honduran population with coendemic Plasmodium falciparum and Plasmodium vivax. American Journal of Tropical Medicine and Hygiene 1998;59(6):868-71.
Rabinovich 2006 {published data only}
  • Rabinovich SA, Le DK, Nguen VH, Morozov EN, Toropov DE, Kukina IV, et al. Efficiency of KAT-quick P.f. test (KAT medical, SAR) among the populations of drug-resistant parasites. Meditsinskaia Parazitologiia i Parazitarnye Bolezni 2006;2:10-2.
Radrianasolo 2007 {published data only}
  • Radrianasolo L, Tafangy PB, Raharimalala LA, Ratsimbasoa AC, Randriamanantena A, Randrianarivelojosia M. Rapid diagnostic test for malaria: preliminary study in Madagascar in 2003. Santé 2007;17(2):69-73.
Rahim 2002 {published data only}
  • Rahim F, Haq HA, Jamal S. Comparison of amradict test with microscopic examinations for rapid diagnosis of malaria. Journal of the College of Physicians and Surgeons Pakistan 2002;12(9):530-3.
Rajendran 2006 {published data only}
  • Rajendran C, Dube S. Field evaluation of rapid immunochromatographic test kit for the diagnosis of Plasmodium falciparum and non-falciparum malaria parasites for Sontipur Distric, Assam. Journal of Parasitic Diseases 2006;30(1):94-7.
Ramutton 2012 {published data only}
  • Ramutton T, Hendriksen IC, Mwanga-Amumpaire J, Mtove G, Olaosebikan R, Tshefu AK, et al. Sequence variation does not confound the measurement of plasma PfHRP2 concentration in African children presenting with severe malaria. Malaria Journal 2012;11:276.
Ratnawati 2008 {published data only}
  • Ratnawati MH, Hatta M, Smits HL. Point-of-care testing for malaria outbreak management. Transactions of the Royal Society of Tropical Medicine and Hygiene 2008;102(7):699-704.
Ratsimbasoa 2012 {published data only}
  • Ratsimbasoa A, Ravony H, Vonimpaisomihanta JA, Raherinjafy R, Jahevitra M, Rapelanoro R, et al. Management of uncomplicated malaria in febrile under five-year-old children by community health workers in Madagascar: reliability of malaria rapid diagnostic tests. Malaria Journal 2012;11:85.
Rehlis 2004 {published data only}
  • Rehlis N, Javor P. Interpretation of immunochromatographic tests with HRP-2 antigen in children under 5 years in an area of high risk of malaria transmission in Papua New Guinea [Interpretacja testow immunochromatographiczynch z antygenem HRP-2 dzieci do lat 5 w rejonie o wysokim ryzyku transmisji zimnicy w Papua Nowej Gwinei]. Wiadomości Parazytologiczne 2004;50(2):201-8.
Reyburn 2007 {published data only}
  • Reyburn H, Mbakilwa H, Mwangi R, Mwerinde O, Olomi R, Drakeley C, et al. Rapid diagnostic tests compared with malaria microscopy for guiding outpatient treatment of febrile illness in Tanzania: randomised trial. BMJ 2007;334(7590):403.
Ricci 2000 {published data only}
  • Ricci L, Viani I, Piccolo G, Fabio A, Calderaro A, Galati L, et al. Evaluation of OptiMAL Assay test to detect imported malaria in Italy. New Microbiologica 2000;23(4):391-8.
Richardson 2002 {published data only}
  • Richardson DC, Ciach M, Zhong KJY, Crandall I, Kain KC. Evaluation of the Makromed dipstick assay versus PCR for diagnosis of Plasmodium falciparum malaria in returned travelers. Journal of Clinical Microbiology 2002;40(12):4528-30.
Richter 2004a {published data only}
  • Richter J, Göbels K, Müller-Stöver I, Hoppenheit B, Häussinger D. Co-reactivity of plasmodial histidine-rich protein 2 and aldolase on a combined immuno-chromographic-malaria dipstick (ICT) as a potential semi-quantitative marker of high Plasmodium falciparum parasitaemia. Parasitology Research 2004;94(5):384-5.
Richter 2004b {published data only}
  • Richter J, Harms G, Müller-Stöver I, Göbels K, Häussinger D. Performance of an immunochromatographic test for the rapid diagnosis of malaria. Parasitology Research 2004;92(6):518-9.
Rimón 2003 {published data only}
Roche 1995 {published data only}
  • Roche J, Benito A, Ayecaba S, Amela C, Molina R, Alvar J. Field evaluation of fluorescence microcopy (QBC) for malaria diagnosis. Bulletin de Liaison et de Documentation de L'OCEAC 1995;28(1):26-9.
Rodríguez-Iglesias 2005 {published data only}
  • Rodríguez-Iglesias M. Rapid serological techniques. Enfermedades Infecciosas y Microbiologia Clinica Monografias 2005;4(2):69-71.
Rodulfo 2007 {published data only}
  • Rodulfo H, De Donato M, Mora R, González L, Contreras CE. Comparison of the diagnosis of malaria by microscopy, immunochromatography and PCR in endemic areas of Venezuela. Brazilian Journal of Medical and Biological Research 2007;40(4):535-43.
Rolland 2006 {published data only}
Rosenthal 2012 {published data only}
Rubio 2001 {published data only}
  • Rubio JM, Buhigas I, Subirats M, Baquero M, Puente S, Benito A. Limited level of accuracy provided by available rapid diagnosis tests for malaria enhances the need for PCR-based reference laboratories. Journal of Clinical Microbiology 2001;39(7):2736-7.
Runsewe-Abiodun 2012 {published data only}
  • Runsewe-Abiodun IT, Efunsile M, Ghebremedhin B, Sotimehin AS, Ajewole J, Akinleye J, et al. Malaria diagnostics: a comparative study of blood microscopy, a rapid diagnostic test and polymerase chain reaction in the diagnosis of malaria. Journal of Tropical Pediatrics 2012;58(2):163-4.
Ryan 2002 {published data only}
Samal 1998 {published data only}
  • Samal KK, Agarwalla A. Intradermal smear vs peripheral blood smear in diagnosis of malaria. Indian Practitioner 1998;51(1):27-8.
Saranya 2003 {published data only}
  • Saranya N. Rapid diagnostic tests, benefits and pitfalls. Indian Journal of Practical Pediatrics 2003;5(2):111-7.
Sayang 2009 {published data only}
  • Sayang C, Soula G, Tahar R, Basco LK, Gazin P, Moyou-Somo R, et al. Use of a histidine-rich protein 2-based rapid diagnostic test for malaria by health personnel during routine consultation of febrile outpatients in a peripheral health facility in Yaounde, Cameroon. American Journal of Tropical Medicine and Hygiene 2009;81(2):343-7.
Schachterle 2011 {published data only}
  • Schachterle SE, Mtove G, Levens JP, Clemens EG, Shi L, Raj A, et al. Prevalence and density-related concordance of three diagnostic tests for malaria in a region of Tanzania with hypoendemic malaria. Journal of Clinical Microbiology 2011;49(11):3885-91.
Schmidt 2003 {published data only}
  • Schmidt WP. Malaria rapid diagnostic tests - perspectives for malaria endemic and non-endemic regions. Laboratoriums Medizin 2003;27(7-8):296-301.
Schmidt 2011 {published data only}
  • Schmidt BA, Mubi M, Premji Z, Ngasala BE, Martensson A, Bjorkman A. Clearance of Plasmodium falciparum as assessed withmicroscopy, RDT and PCR after anti-malarial treatment in Tanzanian children. 7th European Congress on Tropical Medicine and International Health; 2011 03-06 October; Barcelona. Tropical Medicine and International Health 2011:111.
Seidahmed 2008 {published data only}
Senn 2012 {published data only}
  • Senn N, Rarau P, Manong D, Salib M, Siba P, Robinson LJ, et al. Rapid diagnostic test-based management of malaria: an effectiveness study in Papua New Guinean infants with Plasmodium falciparum and Plasmodium vivax malaria. Clinical Infectious Diseases 2012;54(5):644-51.
Sezibera 2009 {published data only}
  • Sezibera C. Fever and treatment of malaria: importance of a strategy of diagnostic-treatment of first class level health services [Fièvre et traitement du paludisme: importance d'une stratégie de diagnostic-traitement au niveau des services de santé de premier echelon]. Thesis 2009.
Shah 2004 {published data only}
  • Shah I, Deshmukh CT. A bedside dipstick method to detect Plasmodium falciparum. Indian Pediatrics 2004;41(11):1148-51.
Shaikh 2013 {published data only}
  • Shaikh S, Memon S, Memon H, Ahmed I. Role of rapid daignostic tests for guiding outpatient treatment of febrile illness in Liaquat University Hospital. Pakistan Journal of Medical Science 2013;29(5):1167-72.
Shakya 2012 {published data only}
  • Shakya G, Gupta R, Pant SD, Poudel P, Upadhaya B, Sapkota A, et al. Comparative study of sensitivity of rapid diagnostic (hexagon) test with calculated malarial parasitic density in peripheral blood. Journal of Nepal Health Research Council 2012;10(1):16-9.
Shamsi 1999 {published data only}
  • Shamsi TS, Ahmed A, Farooqui AI, Waraich S. Rapid diagnosis of malaria: a new approach. Journal of the Pakistan Medical Association 1999;49(1):16-7.
Sharma 1999 {published data only}
  • Sharma SK, Tyagi PK, Haque MA, Padhan K. Field studies on the sensitivity and specificity of an immunochromatographic test for the detection of Plasmodium falciparum malaria in tribal areas of Orissa. Indian Journal of Malariology 1999;36(3-4):65-9.
Sharma 2008 {published data only}
  • Sharma MK, Rao VK, Agarwal GS, Rai GP, Gopalan N, Prakash S, et al. Highly sensitive amperometric immunosensor for detection of Plasmodium falciparum histidine-rich protein 2 in serum of humans with malaria: comparison with a commercial kit. Journal of Clinical Microbiology 2008;46(11):3759-65.
She 2007 {published data only}
Shenoi 1996 {published data only}
  • Shenoi UD. Laboratory diagnosis of malaria. Indian Journal of Pathology and Microbiology 1996;39(5):443-5.
Shiff 1993 {published data only}
  • Shiff CJ, Minjas J, Premji Z. The ParaSight-F test: a simple rapid manual dipstick test to detect Plasmodium falciparum infection. Parasitology Today 1994;10(12):494-5.
  • Shiff CJ, Premji Z, Minjas JN. The rapid manual ParaSight-F test. A new diagnostic tool for Plasmodium falciparum malaria. Transactions of the Royal Society of Tropical Medicine and Hygiene 1993;87(6):646-8.
Shillcutt 2008 {published data only}
  • Shillcutt S, Morel C, Goodman C, Coleman P, Bell D, Whitty CJM, et al. Cost-effectiveness of malaria diagnostic methods in sub-Saharan Africa in an era of combination therapy. Bulletin of the World Health Organization 2008;86(2):101-10.
Shirayama 2008 {published data only}
  • Shirayama Y, Phompida S, Kuroiwa C. Monitoring malaria control in Khammouane province, Laos: an active case detection survey of Plasmodium falciparum malaria using the Paracheck rapid diagnostic test. Transactions of the Royal Society of Tropical Medicine and Hygiene 2008;102(8):743-50.
Shujatullah 2006 {published data only}
  • Shujatullah F, Malik A, Khan HM, Malik A. Comparison of different diagnostic techniques in Plasmodium falciparum cerebral malaria. Journal of Vector Borne Diseases 2006;43(4):186-90.
Shujatullah 2009 {published data only}
  • Shujatullah F, Khan HM, Malik A, Malik A. Evaluation of ParaSight-F test in diagnosis of Plasmodium falciparum infection. JK Science 2009;11(1):16-9.
Singer 2004 {published data only}
  • Singer LM, Newman RD, Diarra A, Moran AlC, Huber CS, Stennies G, et al. Evaluation of a malaria rapid diagnostic test for assessing the burden of malaria during pregnancy. American Journal of Tropical Medicine and Hygiene 2004;70(5):481-5.
Singh 1997a {published data only}
  • Singh N, Valecha N, Sharma VP. Malaria diagnosis by field workers using an immunochromatographic test. Transactions of the Royal Society of Tropical Medicine and Hygiene 1997;91(4):396-7.
Singh 1997b {published data only}
  • Singh N, Singh MP, Sharma VP. The use of a dipstick antigen-capture assay for the diagnosis of Plasmodium falciparum infection in a remote forested area of Central India. American Journal of Tropical Medicine and Hygiene 1997;56(2):188-91.
Singh 2000b {published data only}
  • Singh N. Usefulness of a dipstick test (ParaSight-F) in high-risk groups for Plasmodium falciparum in Central India. Current Science 2000;79(4):406-7.
Singh 2000c {published data only}
  • Singh N, Valecha N. Evaluation of a rapid diagnostic test, 'Determine malaria pf', in epidemic-prone, forest villages of central India (Madhya Pradesh). Annals of Tropical Medicine and Parasitology 2000;94(5):421-7.
Singh 2001 {published data only}
  • Singh N, Shukla M. An assessment of the usefulness of a rapid immuno-chromatographic test 'Determine malaria Pf' in evaluation of intervention measures in forest villages of central India. BMC Infectious Diseases 2001;1:10.
Singh 2002a {published data only}
  • Singh N, Saxena A, Sharma VP. Usefulness of an inexpensive, Paracheck test in detecting asymptomatic infectious reservoir of Plasmodium falciparum during dry season in an inaccessible terrain in central India. Journal of Infection 2002;45(3):165-8.
Singh 2002b {published data only}
  • Singh N, Shukla MM. Short report: Field evaluation of posttreatment sensitivity for monitoring parasite clearance of Plasmodium falciparum malaria by use of the Determine Malaria Pf test in Central India. American Journal of Tropical Medicine and Hygiene 2002;66(3):314-6.
Singh 2004a {published data only}
  • Singh N, Nagpal AC. Performance of the OptiMAL dipstick test for management of severe and complicated malaria cases in a tertiary hospital, central India. Journal of Infection 2004;48(4):364-5.
Singh 2005a {published data only}
  • Singh N, Saxena A, Awadhia SB, Shrivastava R, Singh MP. Evaluation of a rapid diagnostic test for assessing the burden of malaria at delivery in India. American Journal of Tropical Medicine and Hygiene 2005;73(5):855-8.
Singh 2005b {published data only}
  • Singh N, Mishra AK, Shukla MM, Chand SK, Bharti PK. Diagnostic and prognostic utility of an inexpensive rapid on site malaria diagnostic test (ParaHIT f) among ethnic tribal population in areas of high, low and no transmission in central India. BMC Infectious Diseases 2005;5:50.
Singh 2005c {published data only}
  • Singh N, Saxena A. Usefulness of a rapid on-site Plasmodium falciparum diagnosis (Paracheck PF) in forest migrants and among the indigenous population at the site of their occupational activities in central India. American Journal of Tropical Medicine and Hygiene 2005;72(1):26-9.
Singh 2007 {published data only}
  • Singh PP, Ahmed R, Singh MP, Terlouw DJ, Ter Kuile FO, Desai MR, et al. Evaluation of the new malaria rapid diagnostic test First Response® Pf/Pv, when used as a screening tool for malaria during pregnancy in central India. American Journal of Tropical Medicine and Hygiene 2007;77(5):341.
Singh 2013 {published data only}
  • Singh N, Bharti PK, Singh MP, Mishra S, Shukla MM, Sharma RK, et al. Comparative evaluation of bivalent malaria rapid diagnostic tests versus traditional methods in field with special reference to heat stability testing in Central India. PLoS One 2013;8(3):e58080.
Skarbinski 2009 {published data only}
  • Skarbinski J, Ouma PO, Causer LM, Kariuki SK, Barnwell JW, Alaii JA, et al. Effect of malaria rapid diagnostic tests on the management of uncomplicated malaria with artemether-lumefantrine in Kenya: a cluster randomized trial. American Journal of Tropical Medicine and Hygiene 2009;80(6):919-26.
Smego 2000 {published data only}
  • Smego RA Jr, Beg A. Rapid diagnostic modalities for malaria. Journal of the Pakistan Medical Association 2000;50(12):398-9.
Sotimehin 2007 {published data only}
  • Sotimehin SA, Runsewe-Abiodun TI, Oladapo OT, Njokanma OF, Olanrewaju DM. Performance of a rapid antigen test for the diagnosis of congenital malaria. Annals of Tropical Paediatrics 2007;27(4):297-301.
Soto Tarazona 2004 {published data only}
  • Soto Tarazona A, Solari Zerpa L, Mendoza Requena D, Llano-Cuentas A, Magill A. Evaluation of the rapid diagnostic test OptiMAL for diagnosis of malaria due to Plasmodium vivax. Brazilian Journal of Infectious Diseases 2004;8(2):151-5.
Srinivasan 2000 {published data only}
  • Srinivasan S, Moody AH, Chiodini PL. Comparison of blood-film microscopy, the OptiMAL dipstick, Rhodamine-123 fluorescence staining and PCR, for monitoring antimalarial treatment. Annals of Tropical Medicine and Parasitology 2000;94(3):227-32.
Stauffer 2005 {published data only}
  • Stauffer WM, Newberry A, Cartwright C, Rosenblatt J, Hanson K, Sloan L, et al. Evaluation of malaria screening in Liberian refugees by blood smear and rapid antigen capture assay (Binax (TM)). Preliminary results. American Journal of Tropical Medicine and Hygiene 2005;73:603.
Stauffer 2006 {published data only}
  • Stauffer WM, Newberry AM, Cartwright CP, Rosenblatt JE, Hanson KL, Sloan L, et al. Evaluation of malaria screening in newly arrived refugees to the United States by microscopy and rapid antigen capture enzyme assay. Pediatric Infectious Disease Journal 2006;25(10):948-50.
Stauffer 2009 {published data only}
  • Stauffer WM, Cartwright CP, Olson DA, Juni BA, Taylor CM, Bowers SH, et al. Diagnostic performance of rapid diagnostic tests versus blood smears for malaria in US clinical practice. Clinical Infectious Diseases 2009;49(6):908-13.
Stephens 1999 {published data only}
  • Stephens JK, Phanart K, Rooney W, Barnish G. A comparison of three malaria diagnostic tests, under field conditions in North-West Thailand. Southeast Asian Journal of Tropical Medicine and Public Health 1999;30(4):625-30.
Stow 1999 {published data only}
  • Stow NW, Torrens JK, Walker J. An assessment of the accuracy of clinical diagnosis, local microscopy and a rapid immunochromatographic card test in comparison with expert microscopy in the diagnosis of malaria in rural Kenya. Transactions of the Royal Society of Tropical Medicine an Hygiene 1999;93(5):519-20.
Strøm 2013 {published data only}
Stürenburg 2009 {published data only}
  • Stürenburg E, Junker R. Point-of-care testing in microbiology: the advantages and disadvantages of immunochromatographic test strips. Deutsches Ärzteblatt International 2009;106(4):48-54.
Surpur 2010 {published data only}
  • Surpur RR, Basvarajjappa KG, Patil VM, Anitha MR, Vijayanth V. Comparative study of peripheral blood smear and rapid diagnostic test kits for antigen detection for diagnosis of malaria. Journal of Pure and Applied Microbiology 2010;4(2):867-70.
Susi 2005 {published data only}
  • Susi B, Whitman T, Blazes DL, Burgess TH, Martin GJ, Freilich D. Rapid diagnostic test for Plasmodium falciparum in 32 Marines medically evacuated from Liberia with a febrile illness. Annals of Internal Medicine 2005;142(6):476-7.
Swarthout 2007 {published data only}
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Tagbo 2007 {published data only}
  • Tagbo O, Henrietta UO. Comparisons of clinical, microscopic and rapid diagnostic test methods in the diagnosis of Plasmodium falciparum malaria in Enugu, Nigeria. Nigerian Postgraduate Medical Journal 2007;14(4):285-9.
Tagbor 2008 {published data only}
  • Tagbor H, Bruce J, Browne E, Greenwood B, Chandramohan D. Performance of the OptiMAL dipstick in the diagnosis of malaria infection in pregnancy. Therapeutics and Clinical Risk Management 2008;4(3):631-6.
Tahar 2013 {published data only}
  • Tahar R, Sayang C, Ngane Foumane V, Soula G, Moyou-Somo R, Delmont J, et al. Field evaluation of rapid diagnostic tests for malaria in Yaounde, Cameroon. Acta Tropica 2013;125(2):214-9.
Tarimo 2001 {published data only}
  • Tarimo DS, Minjas JN, Bygbjerg IC. Malaria diagnosis and treatment under the strategy of the integrated management of childhood illness (IMCI): relevance of laboratory support from the rapid immunochromatographic tests of ICT Malaria P.f/P.v and OptiMAL. Annals of Tropical Medicine and Parasitology 2001;95(5):437-44.
Taylor 2002 {published data only}
  • Taylor WRJ, Widjaja H, Basri H, Fryauff DJ, Ohrt CT, Taufik, et al. Assessing the ParaSight®-F test in Northeastern Papua, Indonesia, an area of mixed Plasmodium falciparum and Plasmodium vivax transmission. American Journal of Tropical Medicine and Hygiene 2002;66(6):649-52.
Tekeste 2012 {published data only}
  • Tekeste Z, Workineh M, Petros B. Comparison of Paracheck Pf test with conventional light microscopy for the diagnosis of malaria in Ethiopia. Asian Pacific Journal of Tropical Disease 2012;2(1):1-3.
Tham 1999 {published data only}
  • Tham JM, Lee SH, Tan TM, Ting RC, Kara UA. Detection and species determination of malaria parasites by PCR: comparison with microscopy and with ParaSight-F and ICT malaria Pf tests in a clinical environment. Journal of Clinical Microbiology 1999;37(5):1269-73.
Thepsamarn 1997 {published data only}
  • Thepsamarn P, Prayoollawongsa N, Puksupa P, Puttoom P, Thaidumrong P, Wongchai S, et al. The ICT Malaria Pf: a simple, rapid dipstick test for the diagnosis of Plasmodium falciparum malaria at the Thai-Myanmar border. South East Asian Journal of Tropical Medicine and Public Health 1997;28(4):723-6.
Tietche 1996 {published data only}
  • Tietche F, Teguia S, Tetanye E, Louis FJ, Mbonda E, Epee MF. Presumptive diagnosis of malaria and access thick drop of positivity in children 0 to 5 years in Yaounde (Cameroon) [Diagnostic presomptif d'acces palustre et positivite de la goutte epaisse chez l'enfant de 0 a 5 ans a Yaounde (Cameroun)]. Medecine d'Afrique Noire 1996;43(6):318-21.
Tjitra 2001a {published data only}
  • Tjitra E, Suprianto S, Dyer ME, Currie BJ, Anstey NM. Detection of histidine rich protein 2 and panmalarial ICT Malaria Pf/Pv test antigens after chloroquine treatment of uncomplicated falciparum malaria does not reliably predict treatment outcome in eastern Indonesia. American Journal of Tropical Medicine and Hygiene 2001;65(5):593-8.
Tjitra 2001b {published data only}
  • Tjitra A, Suprianto S, McBroom J, Currie BJ, Anstey NM. Persistent ICT malaria P.f/P.v. panmalarial and HRP2 antigen reactivity after treatment of Plasmodium falciparum malaria is associated with gametocytemia and results in false-positive diagnoses of Plasmodium vivax in convalescence. Journal of Clinical Microbiology 2001;39(3):1025-31.
Trachsler 1999 {published data only}
Uguen 1995 {published data only}
  • Uguen C, Rabodonirina M, De Pina JJ, Vigier JP, Martet G, Maret M, et al. ParaSight-F rapid manual diagnostic test of Plasmodium falciparum infection. Bulletin of the World Health Organization 1995;73(5):643-9.
Uneke 2008a {published data only}
Uneke 2008b {published data only}
  • Uneke CJ, Iyare FE, Oke P, Duhlinska DD. Assessment of malaria in pregnancy using rapid diagnostic tests and its association with HIV infection and hematologic parameters in South-Eastern Nigeria. Haematologica 2008;93(1):143-4.
Uzochukwu 2009 {published data only}
  • Uzochukwu BSC, Obikeze EN, Onwujekwe OE, Onoka CA, Griffiths UK. Cost-effectiveness analysis of rapid diagnostic test, microscopy and syndromic approach in the diagnosis of malaria in Nigeria: implications for scaling-up deployment of ACT. Malaria Journal 2009;8:265.
Valéa 2009 {published data only}
Valecha 1998 {published data only}
Valecha 2002 {published data only}
  • Valecha N, Eapen A, Usha Devi C, Ravindran J, Aggarwal J, Subbarao S. Field evaluation of the ICT Malaria P.f./P.v. immunochromatographic test in India. Annals of Tropical Medicine and Parasitology 2002;96(3):333-6.
Van den Ende 1998 {published data only}
  • Van den Ende J, Vervoort T, Van Gompel A, Lynen L. Evaluation of two tests based on the detection of histidine rich protein 2 for the diagnosis of imported Plasmodium falciparum malaria. Transactions of the Royal Society of Tropical Medicine and Hygiene 1998;92(3):285-8.
VanderJagt 2005 {published data only}
  • VanderJagt TA, Ikeh EI, Ujah IOA, Belmonte J, Glew RH, VanderJagt DJ. Short communication: Comparison of the OptiMAL rapid test and microscopy for detection of malaria in pregnant women in Nigeria. Tropical Medicine and International Health 2005;10(1):39-41.
Van der Palen 2009 {published data only}
  • Van der Palen M, Gillet P, Bottieau E, Cnops L, Van Esbroeck M, Jacobs J. Test characteristics of two rapid antigen detection tests (SD FK50 and SD FK60) for the diagnosis of malaria in returned travellers. Malaria Journal 2009;8:90.
Van Dijk 2009 {published data only}
van Hellemond 2009 {published data only}
  • van Hellemond JJ, Rutten M, Koelewijn R, Zeeman AM, Verweij JJ, Wismans PJ, et al. Human Plasmodium knowlesi infection detected by rapid diagnostic tests for malaria. Emerging Infectious Diseases Journal 2009;15(9):1478-80.
Venkatesh 2007 {published data only}
  • Venkatesh V, Patibandla PK, Agarwal GG, Awasthi S, Ahuja RC, Nag VL, et al. Performance characteristics of a rapid diagnostic test for malaria, when used to confirm cerebral malaria in children and young adults. Annals of Tropical Medicine and Parasitology 2007;101(1):85-7.
Verlé 1996 {published data only}
Voller 1993 {published data only}
Waltz 2007 {published data only}
Wang J-Y 2007 {published data only}
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Wanji 2008 {published data only}
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Wiese 2006 {published data only}
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Willcox 2009 {published data only}
  • Willcox ML, Sanogo F, Graz B, Forster M, Dakouo F, Sidibe O, et al. Rapid diagnostic tests for the home-based management of malaria, in a high-transmission area. Annals of Tropical Medicine and Parasitology 2009;103(1):3-16.
Williams 2008 {published data only}
  • Williams HA, Causer L, Metta E, Malila A, O'Reilly T, Abdulla S, et al. Dispensary level pilot implementation of rapid diagnostic tests: an evaluation of RDT acceptance and usage by providers and patients; Tanzania, 2005. Malaria Journal 2008;7:239.
Wilson 2013 {published data only}
Win 2001 {published data only}
  • Win TT, Tantular IS, Pusarawati S, Kerong H, Lin K, Matsuoka H, et al. Detection of Plasmodium ovale by the ICT malaria P.f./P.v. immunochromatographic test. Acta Tropica 2001;80(3):283-4.
Wolday 2001 {published data only}
  • Wolday D, Balcha F, Fessehaye G, Birku Y, Shepherd A. Field trial of the RTM dipstick method for the rapid diagnosis of malaria based on the detection of Plasmodium falciparum HRP-2 antigen in whole blood. Tropical Doctor 2001;31(1):19-21.
Wongsrichanalai 1999 {published data only}
  • Wongsrichanalai C, Chuanak N, Tulyayon S, Thanoosingha N, Laoboonchai A, Thimasarn K, et al. Comparison of a rapid field immunochromatographic test to expert microscopy for the detection of Plasmodium falciparum asexual parasitemia in Thailand. Acta Tropica 1999;73(3):263-73.
Wongsrichanalai 2001 {published data only}
Wongsrichanalai 2007 {published data only}
  • Wongsrichanalai C, Barcus MJ, Muth S, Sutamihardja A, Wernsdorfer WH. A review of malaria diagnostic tools: microscopy and rapid diagnostic test (RDT). American Journal of Tropical Medicine and Hygiene 2007;77(6 Suppl):119-27.
Woyessa 2013 {published data only}
  • Woyessa A, Deressa W, Ali A, Lindtjørn B. Evaluation of CareStartTM malaria Pf/Pv combo test for Plasmodium falciparum and Plasmodium vivax malaria diagnosis in Butajira area, south-central Ethiopia. Malaria Journal 2013;12:218.
Wu 2005 {published data only}
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Yadav 1997 {published data only}
  • Yadav RS, Sharma VP, Srivastava HC. Field evaluation of an antigen detection immunochromatographic test for diagnosis of Plasmodium falciparum malaria in India. Tropical Medicine 1997;39(2):45-9.
Yadav 2012 {published data only}
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Yavo 2002 {published data only}
  • Yavo W, Ackra KN, Menan EIH, Barro-Kiki PC, Kassi RR, Adjetey TAK, et al. Comparative study of four techniques used in Cote d'Ivoire for malaria's biological diagnosis. Bulletin de la Société de Pathologie Exotique 2002;95(4):238-40.
Zakai 2003 {published data only}
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Zerpa 2007 {published data only}
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Zheng 1999 {published data only}
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Zhu 1998 {published data only}
  • Zhu W, Tang L, Zheng X, Luo M, Gu Z, Qian H, et al. Diagnosis of falciparum malaria by immunochromatographic test. Chinese Journal of Parasitology and Parasitic Diseases 1998;16(2):94-6.
Zikusooka 2008 {published data only}
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Zurovac 2008 {published data only}
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Citing Literature

  • Number of times cited: 2
  1. 1David G. Lalloo, Delane Shingadia, David J. Bell, Nicholas J. Beeching, Christopher J.M. Whitty, Peter L. Chiodini, UK malaria treatment guidelines 2016, Journal of Infection, 2016, 72, 6, 635CrossRef
  2. 2Obaro S. Michael, Malaria RDT diagnosis: Magnifying a curious point, Travel Medicine and Infectious Disease, 2015, 13, 3, 267CrossRef