Diagnostic Test Accuracy Review

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Rapid diagnostic tests for diagnosing uncomplicated P. falciparum malaria in endemic countries

  1. Katharine Abba1,*,
  2. Jonathan J Deeks2,
  3. Piero L Olliaro3,
  4. Cho-Min Naing4,
  5. Sally M Jackson1,
  6. Yemisi Takwoingi2,
  7. Sarah Donegan1,
  8. Paul Garner1

Editorial Group: Cochrane Infectious Diseases Group

Published Online: 6 JUL 2011

Assessed as up-to-date: 14 JAN 2010

DOI: 10.1002/14651858.CD008122.pub2


How to Cite

Abba K, Deeks JJ, Olliaro PL, Naing CM, Jackson SM, Takwoingi Y, Donegan S, Garner P. Rapid diagnostic tests for diagnosing uncomplicated P. falciparum malaria in endemic countries. Cochrane Database of Systematic Reviews 2011, Issue 7. Art. No.: CD008122. DOI: 10.1002/14651858.CD008122.pub2.

Author Information

  1. 1

    Liverpool School of Tropical Medicine, International Health Group, Liverpool, Merseyside, UK

  2. 2

    University of Birmingham, Public Health, Epidemiology and Biostatistics, Birmingham, UK

  3. 3

    World Health Organization, UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), Geneva, Switzerland

  4. 4

    International Medical University, Division of Community Medicine, Kuala Lumpur, Malaysia

*Katharine Abba, International Health Group, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, Merseyside, L3 5QA, UK. K.abba@liverpool.ac.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions), comment added to review
  2. Published Online: 6 JUL 2011

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Background

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms

 

 

Target condition being diagnosed

Malaria is a life-threatening illness, caused by the asexual form of the parasitic protozoan Plasmodium. Most cases of malaria are uncomplicated, commonly presenting with fever and sometimes with other non-specific symptoms including headache, and aches and pains elsewhere in the body (Gilles 1991; WHO 2003). A few people develop severe malaria, with confusion, weakness, coma and other life-threatening complications. Malaria is curable, and early, prompt and accurate diagnosis followed by appropriate treatment helps to reduce illness and death, (WHO 2003) and is central to current malaria control policy (Bell 2006; WHO 2005).

The two most common species of malaria parasite are Plasmodium falciparum and Plasmodium vivax. P. falciparum malaria is by far the most common type of malaria in Africa, and is also endemic in parts of Asia and South America. It is the most common cause of severe malaria, is responsible for almost all malaria deaths, and can cause other complications such as anaemia and, in pregnancy, low birth-weight babies. Vivax malaria is a relapsing form, which is rarely fatal but can cause serious anaemia in children. Less common human malaria parasite species include P. malariae and P. ovale.

In 2008, there were between 190 million and 311 million cases of malaria worldwide (WHO 2009a). Around 85% of these cases were in Africa; 10% were in South East Asia; 4% were in the Eastern Mediterranean region; and 1% were in South America (WHO 2009a). In the same year, there were between 708,000 and 1,003,000 deaths from malaria; 89% were in Africa and 85% were children under the age of five years (WHO 2009a).

People who are repeatedly exposed to malaria infection develop a partial and incomplete immunity. 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 ISO13485:2003 manufacturing standards (WHO 2009). RDTs do not require a laboratory or any special equipment (WHO 2006); they are simple to use and can give results as a simple positive/ negative result, within 15 minutes (Talman 2007). RDTs are therefore, 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 extremes of temperature. They may also fail to detect malaria in cases where there are low levels of parasites in the blood, and false positives are possible due to cross reactions or gametocytaemia (infection with the sexual stage of the parasite only) (Kakkilaya 2003).

RDTs use antibodies to detect one or several antigens. The most commonly used antibodies react to histidine-rich protein-2 (HRP-2), aldolase and plasmodium lactate dehydrogenase (pLDH) (Talman 2007). HRP-2 is a marker for P. falciparum, while pLDH antibodies can be specific for P. falciparum, or P. vivax, or may detect all species (including P. ovale and P. gambiae) or other combinations of these species. Aldolase antibodies are pan-specific, detecting all types of malaria parasite but not differentiating between them. Until recently, there were seven main types of commercially-available test, using different antigen combinations as described in  Table 1  below (Bell 2006).

Since this classification was developed, the following test types have also become available.

  • Pan pLDH antibodies only, with the following possible results: no malaria; P. falciparum, P. vivax, P. ovale and/or P. malariae; and invalid (as for Type 7 tests).
  • P. vivax-specific pLDH antibodies only.
  • pLDH antibody lines detecting P. vivax, P. ovale and P. malariae in combination.

The different test types detect different malaria species and combinations of species; the choice of RDT used will therefore depend on which species are endemic in the area.  Table 2 shows the type of tests that are appropriate for use in the different malaria 'zones' of the world.

HRP-2 can stay in the blood for up to 28 days after starting antimalarial therapy (Kakkilaya 2003). Because of this 'persistent antigenaemia', it is not possible to use these tests for 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), but may persist in the presence of gametocytes.

 

Reference tests

Microscopic examination of Giemsa-stained thick and thin blood films remains the conventional laboratory method for malaria diagnosis, but needs to be conducted by microscopists with adequate training and equipment. Microscopic examination displays a good sensitivity and specificity, and 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 by examining a fixed number of fields; infections may be missed if slides are not examined carefully (Wongsrichalanai 2007). Very low parasitaemia may be missed even by good quality microscopy; the limit of detection of thick smear microscopy has been estimated at between around four and 20 asexual parasites per μl, although under field conditions a threshold of between 50 and 100 asexual parasites per μl is more realistic (Wongsrichalanai 2007). On the whole, false positive results are the result of poor slide preparation or reading (Wongsrichalanai 2007).

Molecular DNA amplification via polymerase chain reaction (PCR) is the most accurate method of detecting parasites in the blood. It eliminates observer error and is more sensitive at low levels of parasitaemia, with limits of detection as low as 0.004 asexual parasites per μl (Hanscheid 2002; Snounou 1993). However, whether this increased ability to detect low level parasitaemias makes it a better diagnostic test is uncertain, as sub-microscopic parasitaemias are of unknown clinical significance and the prevalence of asymptomatic sub-microscopic infection is high in some areas (May 1999). In addition, PCR may be prone to false positive results due to contamination of samples if laboratory standards are not sufficiently high. PCR is currently not widely available outside of research settings, as it needs specially-trained technicians and a well-equipped laboratory.

 

Rationale

Diagnostic tests for malaria in endemic areas are now recommended as routine by the WHO in all patients suspected of malaria before any treatment begins (WHO 2010). This is due to a shift in drug treatment policy away from cheap, often relatively ineffective, drugs, towards artemisinin-based combination treatment (ACTs), which are highly effective, expensive, and need to be used properly to prevent resistance developing.

There is a long-standing recognition that good quality, standard malaria microscopy is relatively expensive and difficult to deliver in many basic, primary health care settings in developing countries, while RDTs for malaria have now become widely available and affordable.

RDTs in malaria could dramatically increase access to prompt diagnosis in primary health care. The question of how a package of care (diagnosis using RDTs with positive cases treated with drugs versus presumptive treatment of all cases with symptoms suggestive of malaria) impacts on health outcomes is to be addressed in a separate forthcoming review (Odaga 2011). However, important policy questions remain to be answered

a) How well do RDTs perform compared to the previous standard of microscopy in diagnosing symptomatic patients?

b) What are the differences in accuracy between different types of commercial test, and individual brands of commercial tests?

This information will help to inform choice, although factors, such as price, product consistency, stability and shelf life will also influence those decisions.

This review is the first of a series of three reviews: the second will examine the accuracy of RDTs for diagnosing uncomplicated P. vivax and other non-falciparum malaria; and the third will assess trials that incorporate RDTs into treatment protocols (Odaga 2011). Previous published reviews have examined travellers only (Marx 2005) or just one particular test (Cruciani 2004).

 

Objectives

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms

To assess the diagnostic accuracy of RDTs for detecting clinical P. falciparum malaria (symptoms suggestive of malaria plus P. falciparum parasitaemia detectable by microscopy) in persons living in malaria endemic areas who present to ambulatory healthcare facilities with symptoms of malaria, and to identify which types and brands of commercial test best detect clinical P. falciparum malaria.

 

Investigation of sources of heterogeneity

We planned to investigate heterogeneity in relation to the index test (by commercial test, test type and grouped by HRP-2/pLDH) and reference tests (microscopy vs PCR), as well as the study participants' age, endemicity of malaria, and geographic area (by continent).

 

Methods

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms
 

Criteria for considering studies for this review

 

Types of studies

Studies evaluating one or more RDTs in 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 consecutive sampling was judged most probable, the study was included. Studies were excluded 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. Studies were also excluded if they were not available in English, or if they presented insufficient information to fully assess their eligibility.

 

Participants

Studies recruiting people living in P. falciparum malaria endemic areas who attended ambulatory healthcare settings with symptoms of uncomplicated malaria. This included patients attending malaria clinics with self-assessed symptoms.

We excluded studies if participants:

1. were non-immune persons 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 suggestive of severe malaria;

4. did not have symptoms suggestive of malaria;

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

In studies with broader inclusion criteria but which presented results stratified by subgroups, we included the data relevant to our inclusion criteria. If studies included some participants with severe malaria, and data specific to a subgroup of participants with uncomplicated malaria could not be extracted, the study was included if 90% or more of the participants had uncomplicated malaria.

 

Index tests

Studies evaluating any immunochromatography-based RDTs specifically designed to detect P. falciparum malaria.

Commerical tests no longer available were included 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, and tests available in both dipstick and cassette format, were included separately. Late prototype tests corresponding to one of the commercially-available types were also included.

 

Comparator tests

Studies were included regardless of whether they made comparisons with other RDT tests.

 

Target conditions

Studies aimed to detect P. falciparum malaria parasitaemia. Studies that presented RDT results relating only to all types of malaria without distinction by species, but where over 98% of malaria infections by reference standard were associated with P. falciparum, were included in this review and analysed as for P. falciparum.

 

Reference standards

Studies were required to diagnose P. falciparum 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 P. falciparum parasites of any density was regarded as a positive smear.
  2. PCR test.

We required that the reference standard was carried out on blood samples taken at the same time and from the same person as the index tests. Where studies used more than one reference standard, we presented data relating to comparisons with each.

 

Search methods for identification of studies

We used a single search strategy for all reviews in the series.

 

Electronic searches

To identify all relevant studies, we searched the following databases using the search terms and strategy identified in Appendix 1. The date of the last search was 14 January 2010.

Cochrane Infectious Diseases Group Specialized Register; MEDLINE; EMBASE; MEDION; Science Citation Index; Web of Knowledge; African Index Medicus; LILACS; IndMED. We used 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 restricted the searches to human studies. We did not limit the search by language or publication status.

 

Data collection and analysis

 

Selection of studies

A single selection procedure was initially used to identify studies for inclusion in either of the two diagnostic test accuracy reviews in the series. The inclusion criteria between the reviews differed only in the target condition and parasite species. Parasite species was therefore the last aspect of the study characteristics to be assessed. One author (KA) initially assessed the titles identified by the search, excluding those obviously irrelevant to the diagnosis of malaria using RDTs.

Letters, review articles, and articles clearly irrelevant based on examination of the abstract and other notes were next excluded and the eligibility of the remaining potentially relevant articles was judged on full text publications independently by two authors (KA SJ) using a proforma. These excluded studies are listed in Characteristics of excluded studies. Any discrepancy was resolved by discussion. Where agreement could not be reached, we consulted a third author (PG or PO). Where it remained unclear whether a study was eligible for inclusion, it was excluded, and we excluded study reports in non-English language reports for logistical reasons.

Studies were named according to the surname of their first author and the year of publication. The study naming used in this review uniquely identifies multiple study cohorts from 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. A slightly different notation (for example, 'Singh 1997(a)' and 'Singh 1997(b)') was used to refer to completely separate studies published by an author of the same name in the same year. Note that more that 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

A standard set of data was extracted from each study cohort, using a tailored data extraction form. Two authors from a pool of three (KA SJ CMN) independently extracted data, and any discrepancies were resolved by discussion. In cases of studies where only a subgroup of participants met the review inclusion criteria, data was extracted and presented only for that particular subgroup. Where two versions of one reference standard or index test were used, for example local clinic and expert standard microscopy or field versus laboratory testing, only the one most likely to yield the highest quality results was included in the review.

For each study, we systematically extracted data on the characteristics of the study, as shown in Appendix 2.

For each comparison of index test with reference test, data were extracted 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 P. falciparum 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 the data were included in the study. In cases of minor disagreement (within 2%) between two by two table data presented in a study report and reported study sample sizes or calculated accuracies, the data in the table were taken as correct. In cases where there was a large discrepancy, the data were not included in the review.

Data were extracted (Smidt 2008) using current manufacturers' instructions in interpreting the RDT results. P. falciparum only and P. falciparum as part of a mixed infection were not distinguished and were classed as positive. Non-falciparum malaria only was classed as negative for this review. 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.

Reference standard positive was defined as 'P. falciparum or mixed infection' and reference standard negative as 'no malaria parasitaemia or non-falciparum malaria parasitaemia only'.

 

Assessment of methodological quality

Two authors from a pool of three (KA SJ CMN) independently assessed the quality of each individual study using the checklist adapted from the QUADAS tool (Whiting 2003). Each question on the checklist was answered with a yes/no response, or noted as unclear if insufficient information was reported to allow a judgement to be made, and the reasons for the judgement made were documented. The criteria used are summarized in Appendix 3.

 

Statistical analysis and data synthesis

The comparisons made in this review can be considered in a hierarchy. The highest level comparison groups tests by antibody type (HRP-2 versus pLDH) and is formed by combining the test types into two groups: HRP-2 antibody-based (Types 1, 2, 3 and 6) and pLDH antibody-based (Types 4 and 5). However, the data on each test type is classified in the primary studies according to commercial brands. In order to provide a coherent description of the studies contributing to each analysis, the results are structured first by grouping studies according to their commercial brand, then grouping brands to form test types, and finally grouping test types by antibody.

The analytical strategy thus compared the test accuracy of commercial brands within each test type before making comparisons between test types, and then between antibodies. 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 demonstrate the variation in accuracy between studies.

Meta-analyses were undertaken where adequate data were available. Hierarchical summary ROC models (HSROC) that included a random-effects term for variation in accuracy and threshold between studies, and non-symmetrical underlying ROC curves, were fitted. The average operating point for each test was identified on each curve, and average sensitivities and specificities computed. Comparisons between tests were made by adding a covariate for brand, test type or antigen to the accuracy and threshold parameters, assuming a common underlying shape. The impact of test type and antibody on the variability of random-effects of accuracy and thresholds was also investigated and separate variance terms included where required. The significance of the difference in test performance was assessed by a likelihood ratio test comparing models with and without covariate terms for accuracy and threshold. Where inadequate studies were available to estimate all parameters, the HSROC model was simplified by assuming a symmetrical shape to the summary ROC curve or fixed-effect estimates.

Where more than one commercial test of the same type was tested on the same patients against the same reference standard, we selected one type 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 types in any analyses comparing commercial brands.

 

Investigations of heterogeneity

We investigated heterogeneity for Type 1 tests because this was the only test category for which there were sufficient studies available. We investigated variation in sensitivity and specificity by adding to the meta-analysis models covariates indicating the following characteristics: age group; P. falciparum endemicity; continent where the study took place; and adequacy of the reference standard.

Age group was classified as: children only; adults only; mixed adults and children; and 'not stated'. Studies including, for example, all ages over the age of five years were classified as 'mixed adults and children'. The age cut-off between adults and children was as used by the study authors.

Endemicity was divided into two categories: high and low. We classified endemicity as 'high' if described by the authors as 'holoendemic', 'hyperendemic' or 'high'; and 'low' if described as 'hypoendemic', 'mesoendemic', 'low' or 'epidemic-prone'. In the case of studies where a reported endemicity was not available, we imputed endemicity using geographical location information provided in the report. This involved mapping the location using 'Google Earth' onto country maps of mean parasite rate in children aged two to ten years in 2007 (Hay 2009) provided by the Malaria Atlas Project (www.map.ox.ac.uk). An example map produced during this process is shown in Figure 1. Study sites with a mean parasite rate of less than 50% were classified as 'low' endemicity to correspond with endemicities of hypoendemic and mesoendemic; study sites with a mean parasite rate of 50% and above were classified as 'high' (Hay 2008). Where the endemicity was unclear and borderline between 'high' and 'low' we assigned it 'high'. Where multiple sites of differing endemicity class were included, and separate results by site were not available, the endemicity assigned to that study was 'mixed'.

 FigureFigure 1. Example map showing P. falciparum malaria endemicities and study locations

For continent classification, where multi-site studies were conducted across continents and results were not available for different sites separately, the location of the study was classified according to the continent with the largest number of participants.

 

Sensitivity analyses

Sensitivity analyses were undertaken to investigate the impact of the reference standard method (PCR and PCR-adjusted microscopy) on the results obtained by microscopy alone.

 

Results

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms
 

Results of the search

The search identified 3971 titles, of which 3418 were excluded on the basis of title alone. A further 168 were excluded without obtaining full-text articles; 29 were excluded because they were letters; and 139 were excluded on the basis of their abstract. We were unable to obtain one article in full-text form. Full-text articles were retrieved for 384 titles, of which 307 were excluded: 254 because they were initially assessed as ineligible; 17 because the reports did not present sufficient detail for us to be sure of their eligibility or ineligibility; 18 because they were available only in non-English languages; 12 because we were unable to extract absolute numbers of true positives, false positives, false negatives and true negatives; and six because they did not present data on P. falciparum malaria, although they were eligible for other reviews in this series.

Two further studies were included as they were identified as eligible during an earlier, scoping stage of the review process but were not identified by the final search.

A total of 74 unique studies described in 79 study reports are therefore included in the review. However, as some of these studies were divided for the purposes of the review (for example, because they used two different reference standards or were conducted in two communities with differing characteristics), 89 separate study cohorts are identified. Fourteen of the 89 study cohorts evaluated more than one test: one compared seven tests, three compared three tests and ten compared two tests. Thus, there are a total of 111 test evaluations reporting a total of 60,396 test results. Microscopy was the reference standard for 104 test evaluations, PCR-adjusted microscopy for two and PCR alone for five,

Sixty-five study cohorts (40,062 participants) assessed the accuracy of Type 1 tests using microscopy as the reference standard; 16 study cohorts (13,010 participants) did the same for a Type 4 test, eight for a Type 2 test (3397 participants), five for a Type 3 test (958 participants) and three for a Type 5 test (1777 participants). Seventy-five cohorts (43,307 participants) assessed the accuracy of HRP-2 antibody-based tests and 19 cohorts (14,787) assessed the accuracy of pLHD antibody-based tests. Only four studies used PCR and one used PCR-adjusted microscopy. A summary of the numbers of studies assessing each RDT type using microscopy, PCR or PCR-adjusted microscopy is shown in  Table 3.

 

Methodological quality of included studies

The overall methodological quality of all included study cohorts is summarized in Figure 2. Just over 50% clearly included a representative spectrum of participants attending ambulatory care settings with symptoms suggestive of malaria; the majority of the remaining studies were unclear, in most cases because they had not described the sampling methods. Around 40% reported an acceptable reference standard, 40% were unclear about the microscopy method, and 20% reported an unacceptable quality reference standard (heterogeneity relating to this criteria is investigated below). As expected, almost all the included studies reported avoidance of partial verification and differential verification, and all reported avoidance of incorporation bias. Around 65% of study cohorts reported blinding of the reference standard to the results of the index test, and around 70% reported blinding of the index test to the results of the reference standard. Only around 25% of studies reported on uninterpretable results while around 60% either explained any withdrawals or were clear that there were no withdrawals.

 FigureFigure 2. Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Twenty-four of the included studies gave details of the number of uninterpretable or invalid RDT results. Eight reported no uninterpretable RDT results; one reported that 14% of tests needed to be repeated; and 15 reported small numbers of uninterpretable test results (<1% to 5%), which were excluded from the analysis. Four studies reported small numbers of uninterpretable microscopy slides, which were excluded from the analysis.

Four key quality items (representative spectrum, adequate reference standard, blinding of reference test, and index test) are used to evaluate each RDT type in  Table 4. A lower proportion of those studies assessing Type 1 and Type 4 RDTs reported an adequate reference standard than those assessing other RDT types (P=0.05) (only 25% of Type 1 evaluations and 29% of Type 2 evaluations were judged to be adequate).

 

Findings

 

PRIMARY COMPARISONS - MICROSCOPY AS THE REFERENCE STANDARD

 

HRP-2 antibody-based tests

 

Type 1 tests

There were 71 evaluations of Type 1 RDTs verified with microscopy (based on data from 40,062 individuals in 65 cohorts described in 55 publications); forty-one were conducted in Africa, 28 in Asia and two in South America.  The median sample size was 269 (range 30 to 7000), and the median prevalence of falciparum malaria parasitaemia was 30% (range 1% to 92%). Only nine of the 71 evaluations were undertaken exclusively in children under the age of five. Ten different RDT brands were evaluated: Paracheck-Pf (27), ParaSight (17), ICT Malaria Pf (16), ParaHIT-F (4), PATH (2), Determine Malaria Pf (1), Rapid Test Malaria (1), Diaspot Malaria (1), New mini-Pf (1), and Hexagon Malaria (1). The earliest study was published in 1996, with the majority published between 1999 and 2007.

Sensitivities of the tests ranged from 42% to 100%, specificities from 65% to 100% (Figure 3). The meta-analytical average sensitivity and specificity (95% confidence interval (CI)) were 94.8% (93.1% to 96.1%) and 95.2% (93.2% to 96.7%), respectively, but heterogeneity was noted between studies. Comparing the ten RDT brands in an analysis of the 71 evaluations revealed no statistically significant differences (P = 0.18), although differences may be masked by the high between study heterogeneity ( Table 5, see Appendix 4 for extra figures). In an analysis restricted only to the four brands evaluated in more than 1000 patients (Paracheck-Pf, ParaSight, ICT Malaria Pf, ParaHIT-F), pairwise comparisons indicated that ICT Malaria Pf was significantly more sensitive than Paracheck-Pf and ParaSight-F (97.7% compared to 93.3% and 94.2%, respectively), whilst ParaHIT-F was significantly more specific than Paracheck-Pf, ParaSight-F, and ICT Malaria Pf (98.9% compared to 95.7%, 94.5% and 94.5%, respectively) (see Appendix 5). However, these differences were small and are based on between-study comparisons, so may have been due to differences between the studies rather than true differences between the test brands.

 FigureFigure 3. Study results of Type 1 RDTs plotted in ROC space (by RDT brand)

 

Type 2 tests

There were eight evaluations of Type 2 RDTs verified with microscopy (based on data from 3397 individuals in eight cohorts described in seven publications); seven were conducted in Asia and one in South America. The median sample size was 347 (range 113 to 896), and the median prevalence of falciparum malaria parasitaemia was 21% (range 6% to 46%). None of the evaluations were undertaken exclusively in children under the age of five. Two different RDT brands were evaluated: ICT Malaria Pf/Pv (6) and NOW ICT Malaria (2). The earliest study was published in 1999, with the majority published between 2000 and 2005.

Sensitivities of the tests ranged from 86% to 100%, specificities from 74% to 100% (Figure 4).  The meta-analytical average sensitivity and specificity (95% CI) were 96.0% (94.0% to 97.3%) and 95.3% (87.3% to 98.3%), respectively. Comparing the two RDT brands in an analysis of the eight evaluations showed no statistically significant differences (P = 1.0) ( Table 5, see Appendix 4 for extra figures).

 FigureFigure 4. Forest plot of study results of Type 2, 3 and 5 RDTs (by RDT brand)

 

Type 3 tests

There were five evaluations of Type 3 RDTs verified with microscopy (based on data from 958 individuals in five cohorts described in five publications); three were conducted in Africa and two in Asia. The median sample size was 194 (range 30 to 291), and the median prevalence of falciparum malaria parasitaemia was 37% (range 25% to 57%). One of the evaluations was undertaken exclusively in children under the age of five. Three different RDT brands were evaluated: SD Malaria Antigen Bioline (2), Parascreen (2), and First Response Malaria (1). The earliest study was published in 2004.

Sensitivities of the tests ranged from 86% to 100%, specificities from 65% to 100% (Figure 4). The meta-analytical average sensitivity and specificity (95% CI) were 99.5% (71.0% to 100%) and 90.6% (80.5% to 95.7%), respectively. There were inadequate data on each RDT brand to make formal statistical comparisons (see Appendix 4 for extra figures).

 

Type 6 tests

No studies assessed the accuracy of Type 6 RDTs verified with microscopy.

 

All HRP-2 antibody based tests

There were 84 evaluations of HRP-2 tests verified with microscopy (based on data from 43,307 individuals in 75 cohorts described in 64 publications); forty-two cohorts were conducted in Africa, 31 in Asia and two in South America. The median sample size was 291 (range 30 to 7000), and the median prevalence of falciparum malaria parasitaemia was 26% (range 1% to 84%). Nine of the evaluations were undertaken exclusively in children under the age of five. Sensitivities of the tests ranged from 42% to 100%, and specificities ranged from 65% to 100%. The meta-analytical average sensitivity and specificity (95% CI) were 95.0% (93.5% to 96.2%) and 95.2% (93.4% to 99.4%), respectively. 

 

pLDH antibody based tests

 

Type 4 tests

There were 17 evaluations of Type 4 RDTs verified with microscopy (based on data from 13,010 individuals in 16 cohorts described in 14 publications); eight were conducted in Africa, eight in Asia and one in South America. The median sample size was 305 (range 75 to 7000), and the median prevalence of falciparum malaria parasitaemia was 32% (range 2% to 61%). Only four of the 17 evaluations were undertaken exclusively in children under the age of five. Four different brands were assessed: OptiMAL (10), OptiMAL-IT (3), Parabank (2) and Carestart Malaria Pf/Pan (2). The earliest study was published in 1999, with the majority published between 2003 and 2007.

Sensitivities of the tests ranged from 80% to 100%, specificities from 90% to 100% (Figure 5). The meta-analytical average sensitivity and specificity (95% CI) were 91.5% (84.7% to 95.3%) and 98.7% (96.9% to 99.5%), respectively. Comparing the four RDT brands in an analysis of the 17 evaluations revealed statistically significant differences (P = 0.009) ( Table 5). Carestart Malaria Pf/Pan was observed to have a higher sensitivity and lower specificity than either OptiMAL, OptiMAL-IT or Parabank  (sensitivity of 97.8% compared with 90.1%, 87.4% and 87.9%, respectively; specificity of 92.2% compared with 99.3%, 97.0% and 98.8%, respectively). See Appendix 4 for extra figures. These differences are based on between-study comparisons, so may have been due to differences between the studies rather than true differences between test brands.

 FigureFigure 5. Study results of Type 4 RDTs plotted in ROC space (by RDT brand)

 

Type 5 tests

There were three evaluations of Type 5 RDTs verified with microscopy (based on data from 1777 individuals in three cohorts described in three publications); two were conducted in Africa, one in Asia and none in South America. The median sample size was 668 (range 240 to 869), and the median prevalence of falciparum malaria parasitaemia was 23% (range 20% to 25%). None of the evaluations were undertaken exclusively in children under the age of five. Two different RDT brands were evaluated: Carestart Pf/Pv (2), and ParaSight Pf/Pv (1). The earliest study was published in 2003.

Sensitivities of the tests ranged from 96% to 99%, specificities from 93% to 100% (Figure 4). The meta-analytical average sensitivity and specificity (95% CI) were 98.4% (95.1% to 99.5%) and 97.5% (93.5% to 99.1%), respectively. There were inadequate data on each RDT brand to make formal statistical comparisons. See Appendix 4 for extra figures.

 

All pLDH antibody based tests

There were 20 evaluations of pLDH antibody-based tests verified with microscopy (based on data from 14,787 individuals in 19 cohorts described in 17 publications); nine cohorts were conducted in Africa, nine in Asia and one in South America. The median sample size was 343 (range 75 to 7000) and the median prevalence of falciparum malaria parasitaemia was 28% (range 2% to 58%). Four of the evaluations were undertaken exclusively in children under the age of five.

Sensitivities of the tests ranged from 80% to 100% and specificities ranged from 90% to 100%. The meta-analytical average sensitivity and specificity (95% CI) were 93.2% (88.0% to 96.2%) and 98.5% (96.7% to 99.4%), respectively. 

 

Comparisons between RDT types

Statistical comparisons could only be made between Type 1 and Type 4 tests, as the number of studies evaluating other test types was inadequate to provide stable estimates of comparisons in the meta-analytical models. Models were fitted allowing for different degrees of heterogeneity for the two test types: results for Type 1 were more heterogeneous than Type 4. Significant differences in test accuracy (P = 0.009) were noted between Type 1 and Type 4 RDTs: Type 4 tests tended to have slightly lower sensitivity (P = 0.34) but significantly higher specificity (P < 0.001) than Type 1 tests in the comparisons based on all data (shown graphically in Figure 6). When the analysis was restricted to the seven studies with direct comparisons, the same patterns were evident, but none were statistically significant ( Table 6). Based on estimates from all studies, Type 1 tests detect on average three more cases out of every 100 people with malaria than Type 4 tests (P = 0.20), but give on average three more false positive diagnoses for every 100 people without malaria (P < 0.001).

 FigureFigure 6. Summary ROC Plot comparing different RDT types verified with microscopy (points are meta-analytical estimates, regions are 95% confidence regions, no regions could be computed for Type 2 and 5 due to small numbers of studies)

Four further studies provided direct comparisons between tests (Appendix 6). One study showed Type 2 to have higher sensitivity than Type 4, but lower specificity than both Type 4 and Type 1; another study showed that Type 3 tests had higher sensitivity than Type 1. The remaining studies showed no significant differences between types. As these comparisons are based on single small studies, their results should be interpreted with caution.

 

Comparisons between HRP-2 and pLDH antibody based RDT Types

RDT types 1 to 3 are all based on HRP-2 antibodies, while types 4 and 5 are related to detection of pLDH antigen. The process of grouping types based on this antibody classification is dominated by the results of the Type 1 tests (which constitute 65 out of 75 of the included HRP-2 antibody-based test studies) and Type 4 tests (which constitute 16 out of 19 of the included pLDH antibody-based test studies). Nine studies provide direct within-participant comparisons of HRP-2 and pLDH test types, eight of which are comparisons of a Type 1 test with a Type 4 test. As for Type 1 and Type 4 tests, it was necessary to allow for different heterogeneity between the test types in the meta-analytical model.

On average, HRP-2 antibody-based tests tend to have slightly higher sensitivity (P = 0.34) but significantly lower specificity (P<0.001) than pLDH antibody-based tests, based on analysis of all data ( Table 6; Figure 7). Differences based on direct comparisons showed the same pattern, but none of the differences were statistically significant. For every 100 malaria cases, around two more are detected with HRP-2 antibody-based tests than pLDH antibody-based tests (P = 0.34 in analysis based on all data, P=0.60 in analysis based on within-study comparisons), but this is at the cost of four false positives for every 100 people without malaria (P < 0.001 in analysis based on all data, P = 0.22 in analysis based on within-study comparisons). 

 FigureFigure 7. Summary ROC Plot comparing HRP-2-based and pLDH-based RDTs across all studies verified with microscopy (points are meta-analytical estimates, regions are 95% confidence regions)

 

Investigations of heterogeneity

Heterogeneity investigations were undertaken to test for differences in RDT performance related to age, endemicity, geographical location and the use of an adequate reference standard. Analyses were restricted to the 65 test cohorts in which RDTs of Type 1 were evaluated. Results are presented in  Table 7.

Nine study cohorts only recruited children aged five years or under, 28 recruited mixed age groups, and in 27 age distributions were not described. No difference in test accuracy was noted by age category (P = 0.41).

Fifty-one study cohorts were in low endemicity areas, 10 in high areas, and three were categorized as being in areas of mixed endemicity. Although specificity appeared to be lower in high endemicity areas, the differences were not statistically significant (P = 0.22).

Significant differences were seen by continent, with lower sensitivity (by 2.7%) and specificity (by 3.7%) in Africa than Asia (P = 0.01). Results from the South American studies showed very high specificity (99.4%) and low sensitivity (88.7%), but should be judged with caution due to only two studies being available.

Fifteen of the Type 1 study cohorts used inadequate reference standards and in 32 the reference standard was unclear, but their results did not differ significantly from the 17 with adequate reference standards (P = 0.34).

 

Sensitivity analysis

For all the above analyses, a sensitivity analysis was undertaken by including the one study in the review (Hopkins 2008b) that used PCR-adjusted microscopy as the reference standard; its inclusion made no difference to any of the findings. 

 

OTHER ANALYSES

 

Use of PCR as a reference standard

Five study cohorts (from four studies) used PCR as a reference standard: two Type 1 RDTs (ParaSight-F and ParaHIT-F), one Type 3 RDT (SD Malaria Antigen Bioline), one Type 4 RDT (OptiMAL-IT) and one Type 6 RDT (PALUTOP). Comparisons were made with the corresponding microscopy evaluations for the first four of these tests (Appendix 7). Use of PCR as a reference standard reduced estimates of the sensitivity of the RDTs but increased estimates of specificity compared with the microscopy-based reference standard for three of the four studies in which comparison was possible. 

For two studies, results are available separately using microscopy and PCR reference standards (Banchongaksorn 1996b; Nicastri 2009b). In one study (Banchongaksorn 1996a; Banchongaksorn 1996b), both sensitivity and specificity for PCR and microscopy were within 1% of each other. In the other (Nicastri 2009a; Nicastri 2009b), specificities were 99% when verified by microscopy and 100% when verified by PCR; sensitivity verified with microscopy was 47% (95% CI 29% to 65%) compared with 72% (95% CI, 51% to 88%) for PCR. In this study with 336 participants, 26 were positive for malaria by PCR, 32 by microscopy and 18 by RDT, suggesting a relatively high rate of false positives for microscopy in the context of a low prevalence.

Five of the included studies presented data, in addition to the comparisons included in the review, on the accuracy of their microscopy reference standard against PCR (excluding one study with only two microscopy positive cases). In three studies, where the quality of the microscopy was unclear (Gaye 1999; Mens 2007b; Nicastri 2009b), sensitivity of microscopy against PCR varied between 69% and 89%; in two studies with adequate quality microscopy (Banchongaksorn 1996b; Rakotonirina 2008), sensitivity varied between 90% and 96%. Specificity of microscopy against PCR was high in all five studies, varying between 96% and 100%.

 

Comparing the accuracy of RDTs and local standard microscopy

In addition to the comparison of RDT against the 'gold standard' microscopy, seven of the included studies presented a comparison of local microscopy against reference standard microscopy. These studies reported widely differing results: one study showed local microscopy services to be slightly more accurate than RDTs (Kolaczinski 2004); three studies showing local microscopy to be extremely inaccurate, with very low specificities of 0% (A-Elgayoum 2009) to 25% (Tagbo 2007), or a sensitivity so low that only around half of cases were detected (De Oliveira 2009); and the others were intermediate but favouring RDTs. The findings of the two studies with an adequate reference standard are presented in Appendix 8.

 

 

Summary of results

 
Summary of results. New Summary of results table

What is the diagnostic accuracy of Rapid Diagnostic Tests for detecting malaria?  What are the best types of tests?

Patients/populationsPeople presenting with symptoms suggestive of uncomplicated malaria 


Prior testingNone


SettingsAmbulatory healthcare settings in P. falciparum malaria endemic areas in Asia, Africa and South America


Index testsImmunochromatography-based rapid diagnostic tests for P. falciparum malaria 


Reference standardConventional microscopy or PCR


ImportanceAccurate and fast diagnosis allows appropriate and quick treatment for malaria to be provided


StudiesConsecutive series of patients; 74 studies presented 111 test evaluations based on 60,396 patient test results


Quality concernsPoor reporting of patient characteristics, sampling method and reference standard methods were common concerns


Test typesQuantity of evidenceBrands (studies)Average pooled resultsConsequences in a cohort of 1000

P. falciparum prevalenceMissed  casesOvertreated non-cases

HRP-2 antibody-based tests compared with microscopy

Type 1

HRP-2 (P. falciparum specific)
71 evaluations

40,062 participants

11,966 malaria cases
Paracheck-Pf (27), ParaSight (17), ICT Malaria Pf (16), ParaHIT-F (4), PATH (2), Determine Malaria Pf (1), Rapid Test Malaria (1), Diaspot Malaria (1), New mini-Pf (1), and Hexagon Malaria (1)sens = 94.8% (93.1% to 96.1%)30%1634

spec = 95.2% (93.2% to 96.7%)50%2624

Type 2

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

3397 participants

790 malaria cases
ICT Malaria Pf/Pv (6) and NOW ICT Malaria (2)sens = 96.0% (94.0% to 97.3%)30%1233

spec = 95.3% (87.3% to 98.3%)50%2024

Type 3

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

958 participants

330 malaria cases
SD Malaria Antigen Bioline (2), Parascreen (2), and First Response Malaria (1)sens = 99.5% (71.0% to 100.0%)30%1262

spec = 90.6% (80.5% to 95.7%)50%2044

pLDH antibody-based tests compared with microscopy

Type 4

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

13,010 participants

4274 malaria cases
OptiMAL (10), OptiMAL-IT(3), Parabank (2) and Carestart Malaria Pf/Pan (2)sens = 91.5% (84.7% to 95.3%)30%269

spec = 98.7% (96.9% to 99.5%)50%437

Type 5

pLDH (P. falciparum specific) and pLDH (P. vivax-specific)
3 evaluations

1777 participants

400 malaria cases
Carestart Pf/Pv (2), and ParaSight Pf/Pv (1)sens = 98.4% (95.1% to 99.5%)30%518

spec = 97.5% (93.5% to 99.1%)50%813

Comparisons

ComparisonComparison typeQuantity of evidence and overall findingSensitivitySpecificity





Type 1 vs Type 4All studies65 Type 1 vs 16 Type 4

Overall significant difference in accuracy P = 0.009
Type 1 3.3% more sensitive than Type 4 (P = 0.20)Type 4 3.5% more specific than Type 1 (P < 0.001)





Within studies7 comparative studies

No overall significant difference in accuracy P = 0.26
Type 1 2.5% more sensitive than Type 4 (P = 0.51)Type 4 2.9% more specific than Type 1 (P = 0.31)





HRP-2 vs pLDHAll studies75 HRP-2 vs 19 pLDH

Overall significant difference in accuracy P = 0.01
HRP-2 1.8% more sensitive than pLDH (P = 0.34)pLDH 3.3% more specific than HRP-2 (P = 0.01)





Within studies9 comparative studies

No overall significant difference in accuracy P = 0.35
HRP-2 0.8% more sensitive than pLDH (P = 0.60)pLDH 2.3% more specific than HRP-2 (P = 0.22)

 

Discussion

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms

Malaria diagnosis and treatment policies have shifted rapidly over the past few years. In 2006, in its guidelines on malaria treatment, the WHO abandoned presumptive treatment with ineffective or only partly effective treatments for the new ACTs. Now, in the second (2010) edition of these guidelines, parasitological diagnosis is expected (WHO 2010): "prompt parasitological confirmation by microscopy or alternatively by RDTs is recommended in all patients suspected of malaria before treatment is started". In primary care in most developing countries, prompt, accurate results from microscopy can't be delivered efficiently, and so demonstrating the sensitivity and specificity of these tests helps reassure policy makers pushing investment in and purchase of this technology.

For P. falciparum malaria, targeting treatment will help to reduce unnecessary drug use and thus help to avoid the development of drug resistance. The test will also help health workers exclude malaria as a cause of fever and thus improve the diagnosis and treatment of other infections. In addition, as malaria control improves as a result of all the new approaches including use of ACTs (Sinclair 2009) and other preventive measures such as impregnated mosquito nets (Lengeler 2004), transmission will drop, immunity will drop and thus prompt detection and treatment becomes even more important for reducing severe illness.

Thus, the current policy question is: how well do RDTs perform in diagnosing symptomatic patients compared to the previous standard of microscopy? There are subsidiary questions about how well the various types and individual commercial tests perform against microscopy and against each other. This information will help to inform choice, although factors such as price, product consistency, stability, and shelf life will also influence those decisions. In addition, areas vary in relation to malaria species not detected by these tests (P. vivax and other non-falciparum malaria species). Thus the choice of commercial product will also depend on whether it is important for clinicians to detect these species. For example, as malaria eradication proceeds and endemicity of malaria falls, being able to detect P. vivax is likely to become more important. In these circumstances, the sensitivity and specificity of the commercial product to P. vivax may be a factor in the choice of product. This is the subject of a forthcoming Cochrane review.

 

Summary of main results

The main results are summarized in the Summary of Results table (Summary of results).

  • There is a large volume of research on the accuracy of RDTs in malaria endemic countries that required meta-analysis.

  • In diagnosing P. falciparum malaria, all tests performed reasonably well. Most studies identified for the current review were carried out on Type 1 (HRP-2) and Type 4 (pLDH) test, with fewer reports available on the other HRP-2 tests (Types 2 and 3) and the other pLDH tests (Type 5).

  • There is a trade-off between sensitivity and specificity for Type 1 and Type 4 tests. Type 1 tests were falsely negative in about 5% of P. falciparum cases and were falsely positive in about 5% of people without P. falciparum. Type 4 tests were falsely negative in 8% to 9% of cases but were falsely positive only in about 1% of non-malaria cases. The results are mirrored by the available direct within-study comparisons between tests (although results were not statistically significant). There were only two brands of Type 1 and Type 4 tests that failed to follow these patterns. These findings support the results of laboratory-based testing undertaken by WHO (WHO 2010a), and probably reflect the different antigens used by different test types. The lower specificity of Type 1 tests may be due to the use of HRP-2 antibodies, which can give a false positive result in cases where a person has recently been successfully treated for P. falciparum malaria, due to persistent antigenaemia. Analysis of all HRP-2 antibody-based tests and all pLDH antibody-based tests was undertaken and gave similar results, but was dominated by Type 1 and Type 4 tests.

  • The sensitivities and specificities of Type 2, Type 3 and Type 5 tests were similar to those of Type 1 and Type 4 tests, but these three types have not been evaluated widely and robust comparisons are not possible. 

  • Studies of Type 1 tests conducted in Africa reported slightly lower estimates of sensitivity and specificity than those conducted in Asia. The reasons for this are unclear, and may relate to the relative quality of the studies conducted in different locations, but are most likely due to higher rates of transmission and persistent antigenaemia in Africa.

  • Reporting of studies is variable: 40% reported an adequate reference standard, 40% did not provide enough information to assess the quality of the reference standard and 20% reported an inadequate reference standard. Other published studies were excluded from the review due to inadequate reporting. It would be helpful in the future for diagnostic test accuracy studies to be more carefully reported on, using the STARD (Bossuyt 2003) criteria, to ensure their inclusion in meta-analyses.

Application of meta-analysis to hypothetical cohort

Table 1 (Summary of results) summarizes the findings of the review and applies them to two hypothetical cohorts of 1000 symptomatic patients. In one of the cohorts, the prevalence of P. falciparum malaria parasitaemia is 30%, while in the other cohort it is 50%.

Falciparum malaria prevalence at 30%: on average, a Type 1 test would miss 16 P. falciparum cases, while a Type 4 test would miss 26 cases. In contrast, a Type 1 test would wrongly identify 34 non-cases as having falciparum malaria, whereas a Type 4 test would only wrongly identify nine non-cases as falciparum malaria.

Falciparum malaria prevalence at 50%: on average, a Type 1 test would miss 26 cases of falciparum malaria, while a Type 4 test would miss 43 cases. In contrast, a Type 1 test would wrongly identify 24 non-cases as having falciparum malaria, whereas a Type 4 test would only wrongly identify seven non-cases as falciparum malaria.

At very low and very high falciparum malaria prevalence: the sensitivity advantage of Type 1 tests, in terms of cases not missed, is less. For example, where prevalence is 10%, Type 1 tests would result in five cases being missed and 43 non-cases incorrectly identified as falciparum malaria. At higher prevalence, the greater sensitivity of Type 1 tests makes a greater difference; at 80% prevalence, Type 1 tests would result in 42 missed cases compared with 68 missed cases with Type 4 tests.

The numbers of false positives presented should be viewed with caution, as some RDTs may be more sensitive than microscopy.

 

Strengths and weaknesses of the review

The results of this review are based on strict and careful searching, study inclusion, and data extraction. The strength of this review is that it allows an assessment to be made between types and brands of test, and also provides an accurate assessment of the trade-offs.

Completeness of evidence

This is a reasonably complete data set. We excluded 18 potentially eligible studies not published in English, 17 studies that did not provide enough information to accurately assess whether they met our inclusion criteria, and 12 studies that gave only calculated values where imputation was not possible. However, it is known that studies of diagnostic test accuracy tend to be poorly indexed (Whiting 2009), and we may therefore have missed some studies despite the comprehensive search; in fact, two of the included studies were identified only in an earlier, scoping search.

Accuracy of the reference standards used:

Microscopy is regarded as the gold standard for malaria, and hence is the primary comparison, although PCR may be more sensitive. Comparisons of microscopy and PCR showed that microscopy was highly accurate when the microscopy methods were classified as 'adequate', but less accurate when the microscopy methods were of poorer quality. However, the quality of the microscopy did not explain any heterogeneity in the meta-analysis of Type 1 tests and therefore is unlikely to be an important factor in the interpretation of the study findings.

Quality and quality of reporting of the included studies:

Many of the included studies was not well reported. For example, reference standards were often not well described, there was often insufficient methodological detail, and numbers sometimes did not add up.

Only 40% of the included studies reported an adequate reference standard and 20% reported an inadequate reference standard. In Type 1 test studies, which were generally older and of lower quality, only 25% reported an adequate reference standard. As the quality of the reference standard did not explain heterogeneity in this analysis, it seems unlikely that including studies with an unclear or inadequate reference standard caused any kind of bias. In addition, only half of the included studies were explicit about patient recruitment involving a consecutive or random series of patients. Blinding of the index and reference tests was reported in the majority of studies (65% and 70%, respectively). Only 60% of studies explained withdrawals or stated that there were none. Sampling did not seem to be a significant problem, as the tests were taken at the same time, and few lost or uninterpretable test results were reported.

Interpretability of subgroup analyses:

The subgroup analysis is interpreted in relation to the antigen type, test type, and brand, and appears to make sense, although a confounding effect of quality over time cannot be excluded with the newer tests. The differences in specificity observed between HRP-2 and pLDH antibody-based tests are significant and replicate those found in systematic laboratory-based in vitro studies (WHO 2010a).

Completeness and relevance of the review:

This review covers P. falciparum malaria only, and stands alone as relevant to areas where P. falciparum malaria predominates. A further Cochrane diagnostic review in this series will cover P. vivax and other non-falciparum malaria species.

 

Applicability of findings to clinical practice and policy

We found no important differences in accuracy between different RDT brands within the same type. Where significant differences between tests were found, these differences were small, and were based on weaker between-study comparisons. For some types, there were insufficient data to analyse differences between brands.

We found Type 1 RDTs to be more sensitive than Type 4, and HRP-2 antibody-based tests to be more sensitive than pLDH antibody-based tests, although the differences were not statistically significant. The direction of this finding corresponds closely with a similar analysis in a diagnostic test accuracy review of RDTs for travellers with fever returning from malaria endemic areas to non-endemic areas (Marx 2005). It also corresponds with laboratory-based testing undertaken by WHO (WHO 2010a), where Type 1 tests had a lower threshold for detection of parasitaemia than Type 4 tests. However, Type 4 tests and pLDH antibody-based tests tended to be more specific, and this difference was significant.

This research assesses sensitivity and specificity in applied research settings. In the field, the quality of microscopy is likely to be lower and the RDTs may not be read so accurately (Hawkes 2009). Further research is required on effective implementation of RDTs, as they can only influence clinical practice if the results are believed and acted upon. There may be a reluctance on the part of both health providers and patients to believe negative RDT results, leading to unnecessary prescribing of antimalarials for negative cases (Tavrow 2000). Trials in this area are in the process of being summarized (Odaga 2011).

The consequences of a false positive are that someone may be treated for malaria when they are not infected. The consequences of a false negative in an endemic area, particularly when related to low parasitaemia, means the patient is unlikely to die. The infection may clear by itself, as people living in endemic areas have partial immunity; if it does not, the illness will recur and they would seek care again.

 

Authors' conclusions

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms

 

Implications for practice

The high sensitivity and specificity of RDTs means they can replace or augment microscopy for diagnosing P. falciparum malaria.

The performance of RDT types varied but the differences were not large. HRP-2-based tests tended to be more sensitive and were significantly less specific than pLDH-based tests. Choice will depend on prevalence of malaria, and we provide data in this review to assist these decisions, although policy makers will also take into account other factors relating to cost and test stability.

 
Implications for research

Future studies should include comparisons between new RDTs and commonly-used Type 1 and/or Type 4 RDTs in the same patients.

Studies should be reported according to the STARD guidelines (Bossuyt 2003), which will also facilitate incorporation into meta-analysis.

Further research on effective implementation of RDTs within routine clinical practice is needed.

 

Acknowledgements

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms

This research was funded through a grant from the UK Department for International Development (DFID) for the benefit of developing countries.

 

Data

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms
Download statistical data

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

 

Appendices

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms
 

Appendix 1. Appendix 1. Search strategy


Search setMEDLINEEMBASE

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* ti, abAntigen detection method$ ti, ab

16Rapid malaria antigen test* ti, abRapid malaria antigen test$ ti, ab

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

Search setWeb of ScienceLILACSMedionAfrican Index medicusIndMed

1Malaria (topic)MalariaMalariaMalariaMalaria

2Plasmodium falciparum (topic)Plasmodium falciparumDiagnos* Or RDT OR (rapid diagnos*)PlasmodiumPlasmodium

31 or 21 or 2 1 or 21 or 2

4Rapid diagnostic test* (topic)Rapid diagnostic test$ Diagnos*Diagnos*

5RDT (topic)RDT dipstickdipstick

6Parasight (topic)Parasight combocombo

7Immunochromatography (topic)Immunochromatograp$ Card testCard test

8Parasight (topic)Parasight parasightparasight

9Dipstick (topic)Dipstick RDTRDT

10Binax (topic)Binax 4 or 5 or 6 or 7 or 8 or 94 or 5 or 6 or 7 or 8 or 9

114 or 5 or 6 or 7 or 8 or 9 or 104 or 5 or 6 or 7 or 8 or 9 or 10 3 and 103 and 10

123 and 113 and 11   



 

Appendix 2. Data extraction: characteristic 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, co-morbidities 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 IndicatorNotes

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 co-morbidities 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 were 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)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 if 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 if 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 of 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. Extra figures

Estimates of average sensitivity and specificity for Type 1 RDT brands (Figure 8)

 FigureFigure 8. Summary estimates of Type 1 RDTs plotted in ROC space (by RDT brand)

Estimates of average sensitivity and specificity for Type 4 RDT brands (Figure 9)

 FigureFigure 9. Summary estimates of Type 4 RDTs plotted in ROC space (by RDT brand)

ROC plot of study results for Type 2, 3 and 5 RDT brands (Figure 10)

 FigureFigure 10. Study results of Type 2, 3 and 5 RDTs plotted in ROC space (by RDT brand)

Study results and estimates of average sensitivity and specificity for Type 2 RDTs (Figure 11)

 FigureFigure 11. Summary estimates of Type 2 RDTs and study results plotted in ROC space (by RDT brand)

Study results and estimates of average sensitivity and specificity for Type 3 RDTs (Figure 12)

 FigureFigure 12. Summary estimates of Type 3 RDTs and study results plotted in ROC space

Study results and estimates of average sensitivity and specificity for Type 5 RDTs (Figure 13)

 FigureFigure 13. Summary estimates of Type 5 RDTs and study results plotted in ROC space

ROC plot of paired results which compare Type 1 and Type 4 RDT brands (Figure 14)

 FigureFigure 14. Paired comparison of Type 1 and Type 4 RDTs. Connecting lines link the direct comparison of pairs of tests in each study.

ROC plot of paired results which compare HRP-2-based tests and pLDH-based tests(Figure 15)

 FigureFigure 15. Paired comparison of HRP-2-based tests and pLDH-based tests. Connecting lines link the direct comparison of pairs of tests in each study.

 

Appendix 5. Type 1 RDT brands evaluated in more than 1000 participants


Ratio of sensitivity

(95% CI)

P value for comparison

Ratio of specificity

 (95% CI)

P value for comparison 
 Paracheck-PfParaSight-FICT Malaria-Pf

Studies (participants)27 (22,319)17 (12,591)16 (2955)





 Studies (participants)Sensitivity % (95% CI)

Specificity % (95% CI)
93.3 (89.7,95.7)

95.7 (92.7,97.5)
94.2 (89.8,96.8)

94.5 (90.3,96.9)
97.7 (95.5,98.8)

94.5 (90.4,97.0)

ParaSight-F17 (12,591)94.2 (90.1,96.7)

94.9 (91.0,97.1)
1.01 (0.96,1.06) P = 0.67

0.99 (0.95,1.03) P = 0.67
 --

ICT Malaria-Pf16 (2955)97.7 (95.5,98.8)

94.7 (90.7,97.1)
1.05 (1.01,1.08) P = 0.01

0.99 (0.95,1.03) P = 0.63
1.04 (1.00,1.07) P = 0.05

1.00 (0.97,1.03) P = 0.93
-

ParaHIT-F4 (1119)92.6 (74.3,98.2)

98.9 (94.4,99.8)
0.99 (0.89,1.11) P = 0.89

1.03 (1.00,1.07), P = 0.03
0.98 (0.88,1.10) P = 0.76

1.04 (1.01,1.08) P = 0.02
0.95 (0.85,1.06) P = 0.33

1.04 (1.01,1.08) P = 0.02



 

Appendix 6. Additional direct comparisons between test types


 SensitivitySpecificity



TP/diseasedP valuechangeTN/not diseasedP valuechange








Type 2 vs Type 1Type 2Type 1Type 2Type 1

Van den Broek 2006144/152137/152P = 0.19+4.6% (-1.3% to +10.5%)674/744740/744P < 0.001-8.9% (-11.0% to -6.7%)


Type 2 vs Type 4Type 2Type 4Type 2Type 4

Van den Broek 2006144/152127/152P = 0.003+11.1% (+4.3% to +18.1%)674/744731/744P < 0.001-7.7% (-10.0% to -5.4%)


Type 3 vs Type 1Type 3Type 1Type 3Type 1

Mens 2007b60/60113/127P = 0.006+11.0% (+5.6% to +16.5%)115/124678/711P = 0.26-2.6%  (-7.4% to +2.2%)

Dev 200417/1721/21P = 1.000% (not estimable)13/139/9P = 1.000% (not estimable)


Type 3 vs Type 4Type 3Type 4Type 3Type 4

Mens 2007b60/6058/60P = 0.50+3.3% (-1.2% to +7.9%)115/124121/124P = 0.14-4.8% (-10.1% to +0.5%)

Dev 200417/1769/85P = 0.07+18.8% (+10.5% to +27.1%)13/1354/54P = 1.000% (not estimable)


Type 5 vs Type 1Type 5Type 1Type 5Type 1

Sharew 2009167/168167/168P = 1.000% (-1.6% to 1.6%)490/500484/500P = 0.32+1.2% (-0.8% to +3.2%)



 

Appendix 7. Summary of results by RDT type and reference standard


 MicroscopyPCR



Type and RDT brandNumber of studiesNumber of patientsPooled sensitivity (95% CI)Pooled specificity (95% CI)Number of studiesNumber of patientsSensitivity (95% CI)Specificity (95% CI)

Type 1, ParaSight-F1712,52194.7

(92.0, 96.5)
94.6

(91.6, 96.6)
152092

(86, 95)
99

(98, 100)

Type 1, ParaHIT-F4111997.0

(92.2, 98.9)
97.2

(92.2, 99.1)
133672

(51, 88)
100

(99, 100)

Type 4, OptiMAL-IT3135687.4

(80.0, 92.4)
96.9

(88.4, 99.3)
131373

(62, 81)
99

(97, 100)

Type 3, SD Malaria Antigen Bioline2224Dev 2004:

100 (80, 100)

Ratsimbasoa 2007:

86 (76, 93)

 
Dev 2004:

100 (75, 100)

Ratsimbasoa 2007:

94 (89, 98)

 
119894

(88, 98)
92

84, 96)

Type 6, PALUTOP00--131395

(88, 98)
97

(94, 99)



 

Appendix 8. Comparison of local microscopy and RDTs verified with good quality microscopy


StudyRDTLocal microscopyRDT


SensitivitySpecificitySensitivitySpecificity

Kolaczinski 2004OptiMAL85.299.779.399.7

De Oliveira 2009Paracheck-Pf52.577.091.796.7



 

Feedback

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms
 

Duplication of test, 3 August 2011

 

Summary

In the background section, under the heading Alternative tests, the same information is repeated as in the previous section Reference tests.

 

Reply

The duplicated text has been removed and the problem resolved. Many thanks for pointing this out.

 

Contributors

K Abba

 

What's new

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms

Last assessed as up-to-date: 14 January 2010.


DateEventDescription

1 December 2011Feedback has been incorporatedAn observant reader noticed that one paragraph in the background section was repeated. This has been removed.



 

History

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms

Protocol first published: Issue 4, 2009
Review first published: Issue 7, 2011


DateEventDescription

6 July 2011AmendedPlain language summary added.



 

Contributions of authors

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms

The Cochrane Editorial Team identified this review as a priority topic for a Cochrane review. The protocol was developed jointly by the authors. Katharine Abba, Sally Jackson, and Cho-Min Naing applied inclusion criteria, extracted data and entered the data, with guidance from Paul Garner, Piero Olliaro, and Jon Deeks. Statistical analysis was carried out by Yemsi Takwoingi, Sarah Donegan and Jon Deeks. Katharine Abba wrote the first draft of the review. All authors contributed to the final manuscript.

 

Declarations of interest

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms

There are no known conflicts of interest.

 

Sources of support

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms
 

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
  • NIHR Cochrane Diagnostic Test Accuracy Support Unit, Not specified.

 

Differences between protocol and review

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms

We intended to consider RDTs for detecting all species of malaria in a single review. We subsequently decided to split the review into two to make it more readable.

We had intended to handsearch reference lists of included articles, contact test manufacturers for any unpublished studies, handsearch conference proceedings, and contact authors and other experts for information on ongoing and unpublished studies. However, due to the number of citations returned by our search (over 4000), these activities were not required.

We added four further exclusion criteria: studies that used active case detection to recruit participants; studies that did not present absolute numbers; studies not published in English; and studies not presenting sufficient information to enable a full assessment of their eligibility.

 

Notes

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data
  10. Appendices
  11. Feedback
  12. What's new
  13. History
  14. Contributions of authors
  15. Declarations of interest
  16. Sources of support
  17. Differences between protocol and review
  18. Notes
  19. Index terms

The CIDG editors responsible for editing this review were Dr Hasifa Bukirwa and Dr Hellen Gelband.

* Indicates the major publication for the study

References

References to studies included in this review

  1. Top of page
  2. AbstractResumenRésumé
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data
  11. Appendices
  12. Feedback
  13. What's new
  14. History
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Notes
  20. Characteristics of studies
  21. References to studies included in this review
  22. References to studies excluded from this review
  23. Additional references
A-Elgayoum 2009 {published data only}
  • A-Elgayoum SME, El-Karim A, El-Feki A, Mahgoub BA, El-Rayah E-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;64:20-6.
Abeku 2008a {published data only}
  • Abeku TA, Kristan M, Jones C, Beard J, Mueller DH, Okia M. 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 2002;7:202.
Abeku 2008b {published data only}
  • Abeku TA, Kristan M, Jones C, Beard J, Mueller DH, Okia M. 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 2002;7:202.
Banchongaksorn 1996a {published data only}
  • Banchongakasorn T, Yomokgui 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;90:244-5.
Banchongaksorn 1996b {published data only}
  • Banchongakasorn T, Yomokgui 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;90:244-5.
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.
Bechem 1999 {published data only}
  • Bechem NN, Leke RFG, Tietche F, Taylor DW. Evaluation of a 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;93:46.
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.
Bharti 2008 {published data only}
  • Bharti PK, Silawat N, Singh PP, Singh MP, Shukla M, Ghand 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.
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.
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.
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 the detection of malaria parasites. Indian Journal of Medical Microbiology 2004;22(2):104-6.
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.
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 of the detection of malaria parasites in human blood samples. American Journal of Tropical Medicine and Hygeine 1999;60(2):173-6.
De Oliveira 2009 {published data only}
  • De Oliveira AM, Skarbinski J, Ouma P, Kariuki S, Barnwell J, Otieno K, et al. Malaria rapid diagnostic test use and performance by facility-based health workers in western Kenya. American Journal of Tropical Medicine and Hygiene 2007;77:338.
  • De Oliveira AM, Skarbinski J, Ouma PO, Kariuki S, Barnwell JW, Otieno K, et al. Performance 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.
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.
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.
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 program. African Journal of Medicine and Medical Sciences 2001;30 Suppl:21-4.
  • Durrheim DN, la Grange JJP, 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;92:32-3.
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):7-10.
  • 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.
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.
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;5:189-92.
Gaye 1999 {published data only}
  • Gaye O, Diouf M, Diallo S. A comparison of thick smears, QBC Malaria, PCR and PATH Falciparum Malaria Test Trip in Plasmodium falciparum diagnosis. Parasite 1999;6:273-5.
Gerstl 2009 {published data only}
  • Gerstl S, Dunkley S, Mukhtar A, De Smet M, Baker A, Maikers 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.
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.
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;96:254-7.
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.
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 2008a {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. The Journal of Infectious Diseases 2008;197:510-8.
Hopkins 2008b {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. The Journal of Infectious Diseases 2008;197:510-8.
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.
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;35:160-2.
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;72:281-293.
Kolaczinski 2004 {published data only}
  • Kolaczinski J, Mohammed N, Ali A, Ali M, Khan N, Ezard N, et al. 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.
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;33:166-72.
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.
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).
Labbe 2001 {published data only}
  • Labbe AC, Pillai DR, Hongvangthing 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.
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.
Mboera 2006b {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.
Mboera 2006c {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.
Mboera 2006d {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.
Mboera 2006e {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.
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;113:285-8.
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.
Mens 2007a {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 2007b {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.
Mharakurwa 1997a {published data only}
Mharakurwa 1997b {published data only}
Mharakurwa 1997c {published data only}
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.
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.
Msellem 2009 {published data only}
  • Msellem MI, Martensson A, Rotllant G, Bhattarai A, Stromberg 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 / Public Library of Science 2009;6(4):p. e1000070.
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.
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.
Nicastri 2009a {published data only}
  • Nicastri E, Bevilacqua N, 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.
Nicastri 2009b {published data only}
  • Nicastri E, Bevilacqua N, 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 2008a {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.
Nigussie 2008b {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.
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;30:123-4.
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;2:159-62.
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.
Pattanasin 2003 {published data only}
  • Pattanasin S, Proux S, Chompasuk D, Luwiradaj K, Jacquier P, Looareesuwan, 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;97:672-4.
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, Menard 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, Menard 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.
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.
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;111:321-4.
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;36:65-9.
Singh 1997 (a) {published data only}
Singh 1997 (b) {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 2000 (a) {published data only}
  • Singh N, Valecha N. Evaluation of a rapid diagnostic test, 'Determine malaria pf', in epidemic-prone, forest villages of central India. Annals of Tropical Medicine and Parasitology 2000;94(5):421-7.
Singh 2000 (c) {published data only}
Singh 2003a {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 2003b {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.
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 and Hygiene 1999;93:519-20.
Tagbo 2007 {published data only}
  • Tagbo O, Henrietta UO. Compariaons of clinical, microscopic and rapid diagnostic test methods in the diagnosis of Plasmodium falciparum malaria in Enugu, Nigeria. Nigerian Postgradulate Medical Journal 2007;14(4):285-9.
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.
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.
Verle 1996 {published data only}
  • Verle P, Binh LN, Lieu TT, Yen PT, Coosemans M. ParaSight-F test to diagnose malaria in hypoendemic and epidemic prone regions of Vietnam. Tropical Medicine and International Health 1996;6:794-6.
Willcox 2009a {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.
Willcox 2009b {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.
Wolday 2001 {published data only}
  • Wolday D, Balca 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;31:18-21.
Wongsrichanalai 1999 {published data only}
  • Wongsrichanalai C, Chuanak N, Tulyayon S, Thanoosingha N, Laoboonchai A, Thimasarn K. 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 2003 {published data only}
  • Wongrichalanai 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-falciparum plasmodium. American Journal of Tropical Medicine and Hygeine 2003;69(1):26-30.
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.

References to studies excluded from this review

  1. Top of page
  2. AbstractResumenRésumé
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data
  11. Appendices
  12. Feedback
  13. What's new
  14. History
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Notes
  20. Characteristics of studies
  21. References to studies included in this review
  22. References to studies excluded from this review
  23. Additional references
A-Elgayoum 2009 (b) {published data only}
  • A-Elgayoum SME, El-Feki EAKA, Mahgoub BA, El-Rayah EA, 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.
Abul 2000 {published data only}
  • Abul Faiz M, Rashid R, Palit R, Rahman M R, 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;94:56-7.
Afzaal 2001 {published data only}
  • Afzaal S, Singh M, Fatima S, Koshy A A. 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.
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.
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;94:55-6.
Arcanjo 2007 {published data only}
  • Arcanjo AL, De Lacerda MVG, Alecrim WD, Alecrim MDC. Evaluation of the Optimal-IT (R) and ICT P.f./P.v (R) rapid dipstick tests for diagnosing malaria within primary healthcare in the municipality of Manaus, Amazonas. Revista Da Sociedade Brasileira de Medicina Tropical 2007;40(1):88-90.
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.
Arrospide 2004 {published data only}
  • Arrospide NV, Marquino QWO, Gutierrez SG. [Evaluacion de una prueba inmunocromatografica ICT P.f/P.v para el diagnostico de malaria por Plasmodium falciparum y Plasmodium vivax en establecimientos de la macroregion norte del Peru]. Revista Peruana de Medicina Experimental y Salud Publica 2004;21(3):134-8.
Arrospide 2004 (a) {published data only}
  • Arrospide N, Puray C, Guzman E, Verano M, Medina S, Mendiz Bal S, Gonzales S. [Uso de pruebas rapidas immunocromatograficas para la deteccion de Plasmodium falciparum en donantes de sangre en Peru]. Revista Peruana de Medicina Experimental y Salud Publica 2004;21(2):76-82.
Arrospide 2006 {published data only}
  • Arrospide V, Flores P, Ruiz C. [Evaluacion de una prueba rapida basada en la deteccion de pLDH para el diagnostico de malaria en areas endemicas del Peru]. Revista Peruana de Medicina Experimental y Salud Publica 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: CareStart Malaria 3 line pLDH (pan, Pf) and Carestart 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}
Assal 1999 {published data only}
  • Assal A, Kauffmann-Lacroix C, Rodier MH, Darde 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;6:119-23.
Avila 2002 {published data only}
  • Avila PE, Kirchgatteri K, Brunialti KCS. Evaluation of a rapid dipstick test, Malar-check, for the diagnosis of Plasmodium falciparum malaria in Brazil. Revista do Instituto de Medicina Tropical de Sao Paulo 2002;44(5):293-6.
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;24:50-1.
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.
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;92:33-4.
Bassene 2009 {published data only}
  • Bassene H, Kenge P, Ndiath MO, Sokhna C, Dupressoir T, Fontenille D, Trape JF. Comparison of PCR, ELISA-CSP and direct microscopic observation methods for the detection of Plasmodium falciparum sporozoites in Anopheles gambiae in Sengal. Buletin of the Exotic Pathology Society 2009;102(4):233-7.
Bassett 1991 {published data only}
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;343:564-8.
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, Psay 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):552-561.
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, Pacific/TDR W HO-Regional Office for the Western. Evaluation of rapid diagnostic tests: malaria. Nature 2006;4: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}
  • Beren-Riha N, Sinicina E, Fleischmann E, Loscher T. Comparison of different methods for delayed post-mortem diagnosis of falciparum malaria. Malaria Journal 2009;8.
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.
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 2009 {published data only}
Bisoffi 2009a {published data only}
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}
Bouchaud 2000 {published data only}
  • Bouchaud O, Houze S, Longuet C, di Piazza J.P, Ruggieri C, Secardin 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.
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, Aussawatheerakui N, 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):322-3.
Bualombai 2006 {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 35;1:35-7.
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 SCA, Arrospide V, Marquino QWO, Gutierrez SS, Alvarez M, Chuquipiondo R. [Evaluacion del uso de una prueba rapida inmunocromatografica en promotores de salud para el diagnostico de la malaria en areas rurales de la Amazonia peruana]. Revista Peruana de Medicina Experimental y Salud Publica 2004;21(1):4-11.
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. Medecine Tropicale 1997;57:353-6.
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;52:386-9.
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):862-866.
Chiodini 1998 {published data only}
Chiodini 2005 {published data only}
Cho 2001 {published data only}
Coleman 2002a {published data only}
  • Coleman RE, Maneechai N, Ponlawat A, Kumpitak C, Rachapaew N, Miller RS, Sattabongkot J. 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 R S, 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.
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 and Tropical Medicine and Hygiene 1997;91:279-82.
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;96:258-65.
Cropley 2000 {published data only}
  • Cropley IM, Lockwood DN, Mack D, Pasvol G, Davidson R.N. 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, Martin-Rabadan 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.
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. Medecine et Maladies Infectieuses 2009;39:36-40.
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):239-246.
De Monbrison 2004 {published data only}
  • De Monbrison F, Gerome 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.
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 Societe de Pathologie Exotique et de Ses Filiales 1987;80:569-80.
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;91:403-5.
Dietze 1995 {published data only}
  • Dietze R, Perkins M, Boulos M, Luz F, Reller B, Corey GR. The diagnosis of Plasmodium falciparum infection using a new antigen detection system. American Journal of Tropical Medicine and Hygiene 1995;52:45-9.
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. 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 2005a {published data only}
  • Durand F, Faure O, Brion JP, Pelloux H. Invalid result of Plasmodium falciparum malaria detection with the Binax NOW Malaria rapid diagnostic test. Journal of Medical Microbiology 2005;54:1115.
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.
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;94:169-70.
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.
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.
Endeshaw 2008 {published data only}
  • Endeshaw TG, Teshome NJ, Graves PaM, Shargie EB, Ejigsemahu Y, 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.
Fan 2000 {published data only}
  • Fan B, Zhang ZX, Wen RS. Diagnosis of falciparum malaria using ICT. Chinese Journal of Parasitology and Parasitological Diseases 2000;18(5):281.
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 F, Palma GI, Saravia NG. Performance of OptiMAL in the diagnosis of Plasmodium vivax and Plasmodium falciparum infections in a malaria referral centre in Colombia. Memorias do Instituto Oswaldo Cruz, Rio de Janeiro 2002;97(5):731-5.
Figueiredo 2003 {published data only}
  • Figueiredo FAF, Figueredo MC, Nascimento JM, Calvosa VSP, Povoa MM, Machado RLD. Performance of an immunochromatography test for vivax malaria in the Amazon region, Brazil. Revista de Saude Publica 2003;37:390-2.
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;102:25-31.
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;75:547-52.
Fryauff 2000 {published data only}
  • Fryauff DJ, Purnomo, Sutamihardja MA, Elyazar IR, Susanti I, Krisin BS, 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;63:139-45.
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. 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.
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;41:597-601.
Gillet 2009 (a) {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 2009 (b) {published data only}
Gillet 2009 (c) {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.
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;51:762-4.
Gonzales-Ceron 2005 {published data only}
  • Gonzalez-Ceron L, Rodriguez MH, Betanzos AF, Abadia A. Efficacy of a rapid test to diagnose Plasmodium vivax in symptomatic patients of Chiapas, Mexico. Salud Publica de Mexico 2005;47(4):282-7.
Grobusch 1999 {published data only}
Grobusch 2002 {published data only}
  • Grobusch MP, Hanscheid 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;21:818-20.
Grobusch 2003 {published data only}
  • Grobusch MP, Hanscheid T, Gobels K, Slevogt H, Zoller T, Rogler 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, Hanscheid T, Gobels K, Slevogt H, Zoller T, Rogler 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.
Gutierrez 2005 {published data only}
  • Gutierrez Y, Paco G, Romero L, Gonzales J‚ Penar LM, Gimenez T. [Fluorometria; un metodo rapido y sencillo para evaluar la Actividad Antipaludica]. Biofarbo 2005;13(13):3-10.
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, Morillon M. Rapid immunochromatographic tests for detection of malaria: principles and strategies for use. Medecine Tropicale 2005;65(4):389-93.
Hanscheid 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 Medical Science 2004;33:15-8.
Hashizume 2006 {published data only}
  • Hasizume 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;120:444-7.
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. Medecine Tropicale 2001;61(2):153-7.
Holmberg 1992 {published data only}
  • Holmberg M, Wahlberg J, Lundeberg J, Pettersson U, Uhlen 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.
Hossain 2008 {published data only}
  • Hossain MA, Afroj S, Rahman MR, Yunus EB, Samad R, Asna ZH. 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.
Houze 2009 {published data only}
  • Houze S, Boly MD, Le Bras J, Deloron P, Faucher J-F. 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).
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}
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 R. Comparison of two commercial assays with expert microscopy for confirmation of symptomatically diagnosed malaria. Journal of Clinical Microbiology 2002;40:4675-8.
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.
Jelinek 1996 {published data only}
  • Jelinek T, Kilian AH, Henk M, Mughusu EB, Nothdurft HD, Loscher 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 [Twee sneltests ter detectie van Plasmodium falciparum]. Tijdschr. 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.
Kakkilaya 2003 {published data only}
Kamugisha 2008 {published data only}
  • Kamugisha ML, Msangeni H, Beale E, Malecela EK, Akida JI, Lemnge MM. 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.
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;90:513-5.
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;54:421-4.
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;58:300-2.
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.
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;91:666-7.
Kim 2008 {published data only}
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 A R, 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;91:398-402.
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.
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. Annals Academy of Medicine Singapore 1999;28:498-501.
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;46:939-42.
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.
Lepere 2004 {published data only}
  • Lepere JF, Macarry A. Malaria diagnosis and treatment in a rural Health Centre in Mayotte (Comoro archipelago, 2002). Sante 2004;14:5-10.
Lim 2001 {published data only}
Llanos Zavalaga 2000 {published data only}
  • Llanos Zavalaga LF, Huayta Zacarias E, Mendoza Requena D, Rosas Aguirre A, Contreras Rios C, Peinada Rodriguez J. [Conocimientos y percepciones de los trabajadores de salud de zona endemica de malaria en el Peru sobre la prueba de diagnostico rapido ParaSight-F]. Revista Medica Herediana 2000;11(4):115-21.
Llanos-Zavalaga 2002 {published data only}
  • Llanos-Zavalaga LF, Villacorta V, Reyes LRC, Lecca GL, Mendoza RD, Mayca P, et al. [Evaluacion de la prueba ICT Malaria P.f/P.v (AMRAD) para la deteccion de P. falciparum y P. vivax en una zona endemica de la Amazonia 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. The 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. The 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 2008;85(11):544-9.
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;82:51-9.
Mayxay 2004 {published data only}
McCutchan 2008 {published data only}
  • McCutchan TF, Piper RC, Makler MT. Use of malaria rapid diagnostic test to identify Plasmodium knowlesi infection. Emerging Infectious Diseases 2008;14:1750-2.
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;103:1237-44.
Menan 1996 {published data only}
  • Menan EIH, Adou-Bryn KD, Mobio SP, Cisse M, Penali K, Kone M. [Bilan des examens parasitologiques du sang pour la recherche du paludisme a l'Institut Pasteur de Cote 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.
Mendoza 2007 {published data only}
  • Mendoza NM, Garcia M, Cortes LJ, Vela C, Erazo R, Perez P, et al. Evaluation of two rapid diagnostic tests, NOW ICT Malaria Pf/Pv and OptiMAL, for diagnosis of malaria. Biomedica 2007;27:571-80.
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.
Metzger 2008 {published data only}
  • Metzger WG, Vivas-Martinez S, Rodriguez I, Goncalves 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;102:2-24.
Mharakurwa 1997 {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;66:61-7.
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 2006;75(5):96.
Mills 2009 {published data only}
  • Mills LA, Kagaayi J, Shott JP, Newell K, Bwanika JB, Ssempijja V, et al. Performance of a prototype malaria rapid diagnostic test versus thick film microscopy among HIV-positive subjects in rural Rakai, Uganda. Transactions of the Royal Society of Tropical Medicine and Hygiene 2009;77(5 (Abstract book)):96.
Minodier 2005 {published data only}
  • Minodier P. Malaria diagnosis: rapid detection tests. Clinical Microbiology Reviews 2005;18(8):386-8.
  • Minodier P, Noel 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 JC, 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 2006;63(2):127-9.
Mohanty 1999 {published data only}
  • Mohanty S, Mishra SK, Mohanty A, Das BS. Immunochromatographic test for the diagnosis of P falciparum malaria. Journal of the Association of Physicians of India 1999;47(2):201-2.
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;28:252-61.
Moody 2000 {published data only}
Moody 2002 {published data only}
Moody 2002a {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;59:228-31.
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.
Moulin 2009 {published data only}
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.
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.
Murray 2003 {published data only}
Murray 2008 {published data only}
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. Wiadomosci Parazytologiczne 2004;50(2):193-9.
Naing 2002 {published data only}
  • Naing C-M, Gatton ML. Performance appraisal of rapid on-site malaria diagnosis (ICT Malaria Pf/Pv tests) in relation to human resources at village level in Myanmar. Acta Tropica 2002;81:13-19.
Nema 2004 {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.
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. The Lancet Infectious Diseases 2006;6(9):582-8.
OMS 1999 {published data only}
  • Organisation Mondiale de la Sante USAID. Directives pour l'evaluation rapide: reconnaissance des symptoms de maladies pour le paludisme grave et complique. Organisation Mondiale de la Sante 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.
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;36:25-6.
Pabon 2007 {published data only}
  • Pabon A, Alvarez G, Yanez J, Cespedes C, Rodriguez Y, Restrepo A, et al. Evaluation of ICT malaria immunochromatographic Binax NOW (R) ICT P.f/P.v test for rapid diagnosis of malaria in a Colombian endemic area. Biomedica 2007;27:225-35.
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;93:517-8.
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.
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;44:747-50.
Park 2006 {published data only}
  • Park TS, Kim JH, Kang CI, Lee BH, Jeon BR, Lee SM, et al. Diagnostic usefulness of SD malaria antigen and antibody kits for differential diagnosis vivax malaria in patients with fever of unknown origin. Korean Journal of Laboratory Medicine 2006;26:241-5.
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.
Penhalbel 2005 {published data only}
  • Penhalbel R, de Souza R, Fugikaha E, Lorenzetti A, Alves RT, Cavasini CE, et al. Evaluation of an immunochromatography test for malaria diagnosis under different storage conditions. Revista da Sociedad Brasileira de Medicina Tropical 2005;38(2):194-5.
Perez 2007 {published data only}
  • Perez H, Bracho C, De La Rosa M. [El paludismo y las pruebas r pidas de diagnostico]. Boletin de Malariologia y Salud Ambiental 2007;47(1):3-13.
Peyron 1999 {published data only}
  • Peyron F. Parasitologic diagnosis of malaria: Routine and new laboratory techniques. Medecine et Maladies Infectieuses 1999;29(Suppl 3):295-301.
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):131-134.
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, Houze 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. [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, Fedekina LI. Diagnosis of malaria by express methods. Klinicheskaia Laboratornaia Diagnosis 2004;1:46-8.
Premji 1994 {published data only}
  • Premji Z, Minjas JN, 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;88:418.
Prou 1988 {published data only}
  • Prou O, Deletoille P. Rapid detection of Plasmodium falciparum antigens by monofluo Kit Plasmodium falciparum. Medecine 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, Kong LD, Van HA N, Morozov YN, Toropov DY, Kukina IV, et al. Efficiency of Kat-Quick P.F test (Lat 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. Cahiers Sante 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 immunochroatographic 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.
Ratnawati 2008 {published data only}
  • Ratnawati MH, Smits HL. Point-of-care testing for malaria outbreak management. Transactions of the Royal Society of Tropical Medicine and Hygiene 2008;102:699-704.
Rehlis 2004 {published data only}
  • Rehlis N, Javor IP. [Interpretacja testow immunochromatographiczynch z antygenem HRP-2 dzieci do lat 5 w rejonie o wysokim ryzyku transmisji zimnicy w Papua Nowej Gwinei]. Wiadomosci 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;334:403.
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 23;4(12):4528-30.
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;23(4):391-8.
Richter 2004 {published data only}
  • Richter J, Gobels K, Muller-Stover I, Hoppenheit B, Haussinger D. Co-reactivity of plasmodial histidine-rich protein 2 and aldolase on a combined immuno-chromatographic-malaria dipstick (ICT) as a potential semi-quantitative marker of high Plasmodium falciparum parasitaemia. Parasitology Research 2004;94:384-5.
Richter 2004a {published data only}
  • Richter J, Harms G, Muller-Stover I, Gobels K, Haussinger D. Performance of an immunochromatographic test for the rapid diagnosis of malaria. Parasitology Research 2004;92:518-9.
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.
Rodriguez-Iglesias 2005 {published data only}
  • Rodriguez-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, Gonzalez 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;40:535-43.
Rolland 2006 {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.
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.
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.
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Seidahmed 2008 {published data only}
Sezibera 2009 {published data only}
  • Sezibera C. [Fievre et traitement du paludisme: importance d'une strategie de diagnostic-traitement au niveau des services de sante de premier echelon]. Thesis Unknown.
Shah 2004 {published data only}
  • Shah I, Deshmukh CT. A bedside dipstick method to detect Plasmodium falciparum. Indian Pediatrics 2004;41(11):1148-51.
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 2008 {published data only}
  • Sharma MK, Rao VK, Agarwal GS, Rai GP, Gopalan N, Prakash S. 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}
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. J K 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 2000 (b) {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 2001 {published data only}
  • Singh N, Shukla M. An assessment of the usefulness of a rapid immuo-chromatographic test 'Determine malaria Pf' in evaluation of intervention measures in forest villages of central India. BMC Infectious Diseases 2001;1(10).
Singh 2002 {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 2002(b) {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 2004 {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 2005 (a) {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 2005 (b) {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;72:26-9.
Singh 2007 {published data only}
  • Singh PP, Ahmed R, Singh MP, Terlouw D.J, Ter Kuile FO, Desai MR, et al. Evaluation of the new malaria rapid diagnostic test First Response (R) 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.
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 RAJ, 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.
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, 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.
Sturenburg 2009 {published data only}
  • Sturenburg E, Junker R. Point-of-care testing in microbiology: the advantages and disadvantages of immunochromatographic test strips. Deutsches Arzteblatt International 2009;106(4):48-54.
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;142:476-7.
Swarthout 2007 {published data only}
  • Swarthout TD, Counihan H, Senga RK, van den Broek I. Paracheck-Pf accuracy and recently treated Plasmodium falciparum infections: is there a risk of over-diagnosis?. Malaria Journal 2007;6:58.
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.
Tarazona 2004 {published data only}
  • Tarazona AS, Zerpa LS, Requena DM, 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.
Tarimo 1999 {published data only}
  • Tarimo DS, Moshiro C, Mpembeni R, Minjas JN. Field trial of the direct acridine orange method and ParaSight-F test for the rapid diagnosis of malaria at district hospitals in Dar es Salaam, Tanzania. Transactions of the Royal Society of Tropical Medicine and Hygiene 1999;93(5):521-2.
Tarimo 2001 {published data only}
  • Tarimo DS, Minjas JN, Bygberg 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, Tjitra E, 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;66:649-52.
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;37:1269-73.
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;28:723-6.
Tietche 1996 {published data only}
  • Tietche F, Teguia S, Tetanye E, Louis FJ, Mbonda E, Epee MF. [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 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 2008 {published data only}
  • Uneke CJ, Lyare 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.
Uneke 2008a {published data only}
Uzuchukwu 2009 {published data only}
  • Uzuchukwu 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.
Valea 2009 {published data only}
Valecha 1998 {published data only}
Valecha 2002 {published data only}
  • Valecha N, Eapen A, Devi CU, Ravindran J, Aggarwal J, Ravindran J. Field evaluation of the ICT Malaria Pf/Pv 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.
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, Koelewinj 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):1578-80.
VanderJagt 2005 {published data only}
Venkatesh 2007 {published data only}
  • Venkatesh V, Patibandla PK, Agarwal GG, Awasthi S, Ahuja RC, Nag VL. 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.
Voller 1993 {published data only}
Waltz 2007 {published data only}
Wang J-Y 2007 {published data only}
  • Wang J-Y, Shi F, Yang Y-T, Gao C-H, Bao Y-F, Tang L-H. Establishment and evaluation of colloid gold labelled immunochromatographic strip tests for rapid diagnosis of malaria. Chinese Journal of Parasitological Diseases 2007;25(5):415-8.
Wanji 2008 {published data only}
  • Wanji S, Kimbi HK, Eyong JE, Tendongfor N, Ndamukong JL. Performance and usefulness of the Hexagon rapid diagnostic test in children with asymptomatic malaria living in the Mount Cameroon region. Malaria Journal 2008;7:89.
WHO 1996 {published data only}
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Wiese 2006 {published data only}
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Williams 2008 {published data only}
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Win 2001 {published data only}
Wongsrichanalai 2001 {published data only}
Wongsrichanalai 2007 {published data only}
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Wu 2005 {published data only}
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Yavo 2002 {published data only}
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Zakai 2003 {published data only}
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Zerpa 2007 {published data only}
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Zikusooka 2008 {published data only}
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Zurovac 2008 {published data only}
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Additional references

  1. Top of page
  2. AbstractResumenRésumé
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data
  11. Appendices
  12. Feedback
  13. What's new
  14. History
  15. Contributions of authors
  16. Declarations of interest
  17. Sources of support
  18. Differences between protocol and review
  19. Notes
  20. Characteristics of studies
  21. References to studies included in this review
  22. References to studies excluded from this review
  23. Additional references
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Wongsrichalanai 2007
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