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Keywords:

  • malaria;
  • diagnostic;
  • rapid diagnostic tests;
  • private health sector
  • paludisme;
  • malaria;
  • diagnostic;
  • tests de diagnostic rapide;
  • secteur privé de santé
  • malaria;
  • diagnóstico;
  • prueba diagnóstica rápida;
  • sector sanitario privado

Summary

  1. Top of page
  2. Summary
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. References

Objectives  This enquiry aimed to provide a snap-shot of availability, price and quality of malaria rapid diagnostic tests (RDTs) in private health facilities at selected sites in six malaria-endemic countries in Africa, South East Asia and South America.

Methods  In each study site, data collectors surveyed private healthcare facilities which were selected based on accessibility from their home institution. Using a questionnaire, information was recorded about the facility itself and the malaria RDT(s) available. Where possible, a small number of RDTs were procured and quality control tested using a standardized procedure.

Results  Of the 324 private healthcare facilities visited, 35 outlets (mainly private clinics and hospitals) were found to supply 10 different types of RDTs products. RDT prices across the six countries ranged from US$1.00 to $16.81. Five of the 14 malaria RDTs collected failed quality control testing.

Conclusions  In the private outlets sampled, the availability of RDTs was limited. Some of the RDTs whose quality we tested demonstrated inadequate sensitivity. This presents a number of risks. Given the more widespread distribution of antimalarials currently planned for private sector facilities, parasite-based diagnosis in this sector will be essential to adhere to the WHO guidelines for effective case management of malaria. Considerable regulation and quality control are also necessary to assure the availability of accurate and reliable RDTs, as well as adequate case management and provider adherence to RDT results. Public sector engagement is likely to be essential in this process.

Objectifs:  Cette enquête visait à fournir une vue rapide sur la disponibilité, le prix et la qualité des tests de diagnostic rapide (TDR) du paludisme dans les établissements de santé privés dans des sites sélectionnés dans six pays endémiques pour le paludisme en Afrique, en Asie du sud-est et en Amérique du sud.

Méthodes:  Dans chaque site d’étude, les collecteurs de données ont enquêté sur les établissements de santé privés, choisis en fonction de l’accessibilitéà partir de leur institution d’origine. En utilisant un questionnaire, les informations ont été enregistrées sur l’installation elle-même et la disponibilité du TDR du paludisme. Lorsque possible, un petit nombre de TDR a été acquis et un contrôle de qualité a été effectué en utilisant une procédure standardisée.

Résultats:  Sur les 324 établissements de santé privés visités, 35 points (essentiellement des cliniques et hôpitaux privés) ont été trouvés, fournissant 10 différents types de produits TDR. Le prix des TDR dans les six pays variait de 1,00 $ US à 16,81 $ US. Cinq TDR du paludisme sur 14 collectés ont échoué au test de contrôle de qualité.

Conclusions:  Dans les points d’accès privés échantillonnés, la disponibilité des TDR était limitée. Certains TDR pour lesquels la qualité a été testée ont démontré une sensibilité inadéquate. Cela pose un certain nombre de risques. Compte tenu de la distribution plus étendue des antipaludiques prévue actuellement dans les établissements du secteur privé, le diagnostic parasitologique dans ce secteur devrait être essentiel afin de se conformer aux directives de l’OMS pour la prise en charge efficace des cas de paludisme. Une réglementation considérable et un contrôle de qualité sont également nécessaires pour assurer la disponibilité de TDR précis et fiables, ainsi qu’une prise en charge adéquate des cas et l’adhésion du prestataire aux résultats des TDR. L’engagement du secteur public est probablement essentiel dans ce processus.

Objetivos:  Esta encuesta tenía por objetivo proveer una fotografía sobre la disponibilidad, el precio y la calidad de las pruebas de diagnóstico rápido (PDRs) de malaria en centros sanitarios privados de seis lugares seleccionados en seis países endémicos para malaria en África, el sudeste Asiático y Sudamérica.

Métodos:  En cada lugar de estudio, los recolectores de datos encuestaron centros sanitarios privados seleccionados basándose en la accesibilidad desde sus hogares. Utilizando un cuestionario, se obtuvo información sobre el centro sanitario así como sobre la disponibilidad de PDR(s). En donde era posible, se recogieron un pequeño número de PDRs y se realizaron pruebas de control de calidad utilizando un procedimiento estándar.

Resultados:  De los 324 centros sanitarios privados visitados, se hallaron 35 puntos de venta (principalmente clínicas privadas y hospitales) que proveían 10 tipos diferentes de PDRs. Los precios de las PDR en los seis países estaban entre US$1.00 y $16.81. Cinco de las 14 PDRs para malaria recolectadas no pasaron las pruebas de control de calidad.

Conclusiones:  En los puntos de venta privados muestreados, la disponibilidad de las PDRs era limitada. Algunas de las PDRs a las que se les realizó un control de calidad, demostraron tener una sensibilidad inadecuada. Esto presenta una serie de riesgos. Dada la mayor distribución de antipalúdicos actualmente planeada para los centros privados, el diagnóstico basado en el parásito en este sector sería esencial para adherirse a las guías de la OMS para realizar un manejo efectivo de casos de malaria. Es necesaria una regulación considerable y un control de calidad para asegurar la disponibilidad de PDRs precisas y fiables, al igual que un manejo adecuado de los casos y la adherencia del proveedor a los resultados de las PDRs. El compromiso del sector público será probablemente esencial en este proceso.


Introduction

  1. Top of page
  2. Summary
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. References

At present, parasite-based diagnosis for malaria is rapidly being scaled up and implemented in many malaria-endemic countries (WHO 2010b), in keeping with current WHO recommendations on malaria case management (WHO 2010a). This is resulting in large-scale procurement of rapid diagnostic tests (RDTs), through the support of national governments and their partners (Roll Back Malaria Procurement and Supply Chain Working Group and Medicines for Malaria Venture 2009). Most of this procurement is targeting the public healthcare sector and driven by Ministries of Health (WHO 2010b). However, a significant proportion of the population accesses health care for malaria-like fever through privately owned health facilities, for reasons that may include convenience, access to care at desired times, location, etc. (Mwenesi 1994; Ndyomugyenyi et al. 1998). A recent study conducted in Uganda reported that 62.7% of febrile patients who sought care outside their home had first gone to drug shops and private clinics (Rutebemberwa et al. 2009). On the Kenyan coast, private health facilities were used first, or solely, in 69% of childhood fevers treated (Molyneux et al. 1999). In Togo, 83% of febrile children under 5 years of age were treated at home with an antimalarial obtained from a street or market vendor (Deming et al. 1989).

Private sector facilities can be classified as either ‘formal’ or ‘informal’ and demonstrate a wide range of products and services as well as skills and quality of care provided (Forsberg et al. 2011; Montagu et al. 2011). Those generally considered to be part of the ‘formal’ private sector include licensed pharmacies (Part One pharmacies), small private clinics, private healthcare practitioners and private hospitals that typically cater to a wealthier clientele. In some countries, the formal private sector may also include licensed drug outlets, such as duka la dawa baridi in Tanzania (Tanzania Food and Drugs Authority http://www.tfda.or.tz/). The ‘informal’ private sector often consists of small outlets, manned by personnel with little to no formal healthcare training (Oshiname & Brieger 1992; Rajakaruna et al. 2006). Illegal stocks of antimalarials and other drugs have been found in some drug stores (Goodman et al. 2004). These may include ‘chemical sellers’ (Ghana), unlicensed patent medicine vendors (Nigeria) or unlicensed duka la dawa (Tanzania).

There are very few published data on the availability and use of parasite-based diagnosis in the private healthcare sector of developing countries. However, a recent study in Nigeria showed that malaria is often diagnosed solely on the basis of symptoms (52%), microscopy was performed in relatively few cases (34.5%), and no RDTs (0%) were performed in the non-hospital facilities investigated (Onwujekwe et al. 2009). This exploratory study of RDT availability, quality and prices in private sector outlets was carried out to encourage and inform more in-depth studies that focus on implementation of private sector malaria diagnosis.

Methods

  1. Top of page
  2. Summary
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. References

Data collection

The study surveyed private health facilities in six malaria-endemic countries in Asia, Africa and South America. In each country, data collection was carried out in major urban areas (such as the capital city) where malaria is endemic, including: Metro Manila and Puerto Princesa (The Philippines), Bangui (Central African Republic), Lagos (Nigeria), Dakar (Senegal), Dar Es Salam (Tanzania) and Iquitos (Peru). All sites chosen have local malaria transmission, except Metro Manila, where patients none-the-less seek care for malaria-like fevers, often on their return from malaria-endemic areas nearby. All data collectors were under the direct supervision of local collaborating institutions. Private health facilities were selected based on the availability and accessibility: data were collected from at least five easily accessible sites in each country, within a 2 h drive of the collaborating institution. Private health facilities were defined as those that were not part of the government-managed healthcare sector and included both formal and informal private sector facilities. To simplify data analysis, several categories of private health facilities used in an ongoing project (ACTwatch 2008) were adapted to suit the needs of this study. Outlets were classified according to the following three categories: private clinical care providers, Part One pharmacies and private diagnostic laboratories.

Data were compiled based on a questionnaire already in use for collecting data on essential medicines, modified to determine RDT availability and pricing. After adequate training by the respective institutions, the data collectors recorded information about the facility itself (type of outlet, level of care) and the malaria RDT(s) available (product name, type, manufacturer, lot number and expiry date). Data collectors also collected information on the ‘price that the patient paid to be tested’ with an RDT, which may include a ‘service fee’ or ‘laboratory fee’ for performing the assay, but did not include a consultation fee. Where possible, data collectors were instructed to buy three RDTs of each product type available (to test one low positive malaria sample, one high positive malaria sample and one negative malaria sample) with the accompanying buffer. The RDTs were selected by the outlet vendors, simulating a routine patient purchase. Quality control testing was performed by the participating institution at each study site, using a standardized protocol (WHO, TDR & FIND 2008).

Rapid diagnostic test quality control

All quality control (QC) testing of malaria RDT samples was carried out by the laboratories of participating institutions using existing QC panels which had been established during the WHO/TDR/FIND/CDC project to create a global malaria specimen bank. QC panels consist of a series of patient samples of parasite-positive (diluted to specified parasite equivalent concentrations) and parasite-negative blood that are collected from the field in malaria-endemic zones. The methods were adapted from the Methods Manual for Laboratory Quality Control Testing of Malaria Rapid Diagnostic Tests, version 5 (WHO, TDR & FIND 2008). Using the QC panels, three RDTs from each purchase were tested: two were tested against samples containing Plasmodium falciparum taken from naturally infected humans, and, where appropriate, Plasmodium vivax, at dilutions of 2000 and 200 parasites per microlitre, respectively; and one RDT was tested against a parasite-negative blood sample.

Results

  1. Top of page
  2. Summary
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. References

Rapid diagnostic test distribution

Data were collected from 324 private health facilities across the six countries. The outlets visited fell into three different categories: 180 private clinical care providers (including clinics, hospitals, medical offices, non-governmental organizations [NGOs] and religious missions), 119 Part One pharmacies (selling prescription medicine at a commercial rate and staffed by pharmacists or qualified health practitioners) and 25 private diagnostic laboratories (all in Lagos, Nigeria).

The majority of RDTs (86%) were found in facilities operated by private clinical care providers. Of the diagnostic laboratories visited (all in Lagos), only one had RDTs available. Only four of the Part One pharmacies assessed supplied RDTs (two in Senegal and two in Tanzania).

Availability of RDTs in facilities visited in each country was as follows:

  •  Iquitos (Peru): no RDTs in any of the 24 private health facilities visited (23 Part One pharmacies and one clinic).
  •  Metro Manila and Palawan province (The Philippines): data were collected from 83 outlets, including 25 private clinics, 41 private hospitals and 17 Part One pharmacies. Of these, 18 private hospitals provided malaria RDTs, of which there were six different types available.
  •  Dakar (Senegal): 17 private clinical care providers and 53 Part One pharmacies were sampled. Of these, two Part One pharmacies had a stock of malaria RDTs.
  •  Lagos (Nigeria): data were collected from 85 private clinics, 25 private diagnostic laboratories and 10 Part One pharmacies. Five private outlets (four private clinics and one diagnostic laboratory) supplied malaria RDTs, of which four different brands were available. Five RDT samples were purchased for assessment at two private facilities in Lagos, Nigeria. One of these had neither packaging instructions nor the manufacturer’s contact details.
  •  Bangui (Central African Republic): 25 outlets were surveyed, including eight NGOs, three religious missions and 14 Part One pharmacies. Nine private facilities had malaria RDTs, including all eight NGOs. These outlets were unwilling to sell RDTs to the data collectors, so no quality control was possible.
  •  Dar es Salam (Tanzania): two outlets were surveyed, both Part One pharmacies. RDT samples were purchased in each facility.

Pricing

Information on pricing was obtained for 24 different samples of RDTs from 22 private outlets in four of the countries involved in this study (Table 1). Overall, RDT prices across the four countries ranged from US$1.00 (at a Part One pharmacy in Dar Es Salam, Tanzania) to $16.81 (at a private hospital in Lagos, Nigeria). Mean and median RDT prices were US$ 7.51 and $7.38, respectively. No further statistic analysis was performed because the sample size was too small to produce any meaningful results.

Table 1.   Malaria RDTs stock availability, prices and quality in sampled private outlets of the six study countries
Country/noPrivate facilities visited/noPrivate facilities with RDTs in stock/noRDT price per test (USD) (Median)RDT products type collected/no% RDT samples that passed quality control (Total purchases /no)
  1. NA: Not applicable.

Central African Republic (Bangui)259NA2NA
Nigeria (Lagos)12042.52–16.81 (5.88)440 (5)
Senegal (Dakar)7022.75–4.00 (3.37)250 (2)
Tanzania (Dar Es Salam)221–2.31 (1.66)250 (2)
Philippines (Metro Manila and Palawan, Puerto Princesa)83183.80–12.00 (7.43)6100 (5)
Peru (Iquitos)240NANANA
TOTAL324351.00–16.81 (7.38)1064 (14)

Quality control

As detailed in Table 1, a total of 14 RDTs that were available for purchase were collected and quality control tested. Nine RDTs passed the quality control testing at both 200 and 2000 Plasmodium falciparum parasites per microlitre. One RDT (malaria RDT Pf Pan type) failed quality control testing at both 200 and 2000 P. falciparum parasites per microlitre, and four RDTs (malaria Pf RDT types) failed to detect a dilution of 200 P. falciparum parasites per microlitre.

Discussion

  1. Top of page
  2. Summary
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. References

In the six endemic countries covered by this study, and within the designated sampling areas, the availability of malaria RDTs in the private sector outlets surveyed was very limited. In Peru, no RDTs were found in any of the private facilities sampled, despite malaria being endemic to the Iquitos region. Even a basic awareness of the role and availability of RDTs seems lacking: in Nigeria, most of the private facilities visited did not know about RDTs for malaria diagnosis.

At the time of the survey, the public sectors of five of the countries (Senegal, Tanzania, Peru, Central African Republic and the Philippines) involved in this study were providing RDTs free of charge, and the sixth (Nigeria) has since commenced implementation, as shown in Table 2. This may add to the challenges of implementing RDTs in the private sector. Furthermore, in the 35 private outlets that were found to stock RDTs, a variety of different brands were available. This is not the case in the public sector, where a single RDT brand is generally selected for country-wide implementation. Only in one country (Tanzania) was there an overlap between the brand of RDT chosen by the National Malaria Control Programme for distribution in the public sector and the products available in the private sector. This will compound the challenges associated with training and quality control.

Table 2.   Malaria RDTs products stocked in sampled private outlets and available in the public sector of the six study countries
CountriesMalaria RDTs available in 2009 (manufacturer)
Public sectorPrivate sector
  1. *These RDTs products were purchased in 2006 and 2007 but were still being distributed in the public sector in 2009. Since then no malaria RDTs have been procured by the Ministry of Heath in Peru.

  2. NA: Not applicable.

Central African Re-publicParacheck (Orchid Biomedical)ICT combo (ICT diagnostics) Hexagon Malaria (Human GMBH)
NigeriaNA (not yet implemented)Diaspot Rapid Test (not indicated) Binax Now malaria (Inverness) One step rapid test (Global devices) Pf Check-1(Lanpharm)
PeruParascreen (Zephyr Biomedical)* Optimal IT (Diamed)*NA
PhilippinesParacheck Pf (Orchid Biomedical System) ICT Malaria Combo Test (ICT Diagnostics)Panbio (Panbio Diagnostics) Parascreen (Zephyr Biomedical) Parabank (Zephyr Biomedical) Paraview (Unimed Inc.) SD Ag P.f/Pan (Standard Diagnostics) Dima Malaria P.f/Pan (MK Bio GmbH)
SenegalSD Malaria Antigen Pf (Standard Diagnostic)Parahit (Span diagnostics) Optimal IT (Diamed)
TanzaniaParaHit (Span Diagnostics) Pilot study in three regionsICT combo (ICT diagnostics) Parahit (Span diagnostics)

The evaluations of RDT quality and performance indicated that some RDTs found in private outlets had inadequate sensitivity. Although limited by sample size, this suggests that the quality of RDTs available in the private sector should be regulated and monitored more closely. Reduced RDT sensitivity may be due to poor manufacture, or inadequate precautions taken during transportation and storage (Jorgensen et al. 2006), issues currently being addressed by many National Malaria Control Programmes but probably not extending beyond the public sector. The survey also highlights a wide range in pricing for malaria RDTs, even across a small sample of private healthcare facilities, and observed deficiencies in packaging and labelling, an issue noted elsewhere (Gillet et al. 2011).

This preliminary enquiry has a number of limitations, many of which are inherent its design and methodology. Most of the data were collected in urban centres. The availability and range of malaria diagnostics are likely to be even worse in rural areas. Without adequate baseline data on the number and location of private sector outlets, a many of discretion was left to the study coordinators at participating institutions, and a variable number of outlets were visited across countries. Future studies should use a larger sampling frame based on a census of private sector outlets to obtain statistically robust data, as well as data on the use and availability of microscopy services. Although the data collected on RDT price included a laboratory or service fee for carrying out the assay, they did not include any consultation fee, which may vary widely between healthcare providers and between countries. Future studies should collect disaggregated data on the following: procurement price, retail price, service or laboratory fee, consultation fee and any other additional charges. These limitations have a direct impact on the strength of our conclusions; however, even this small study highlights the wide variation in availability, price, and quality of RDTs in the private healthcare sector.

The WHO today recommends that ACTs should be provided only when malaria is confirmed with parasite-based diagnosis. Recent initiatives to increase access to ACTs in the private sector, such as the Affordable Medicines Facility for Malaria (The Global Fund 2010), highlight the need to address parasite-based diagnosis in this sector. Lack of RDT use and the resultant over prescription of ACTs increase the risk of developing parasite-resistance to these valuable drugs and can delay appropriate management of non-malarial fevers, also a major cause of child mortality (Black et al. 2010). However, if RDTs are widely used, the lack of quality control of RDTs in the private sector can also present a potential risk to patients, through incorrect diagnosis and inappropriate withholding of antimalarial treatment. Poor quality RDTs in the private sector may also reduce confidence in public sector programmes thus hindering the improvements in public sector management of febrile disease.

The introduction of routine parasite-based diagnosis into the private sector will be essential to effectively implement the WHO recommendations on parasite-based diagnosis, as this sector is vital to ensuring adequate access to ACTs in many countries (Moon et al. 2009; Sabot et al. 2009). However, the use of RDTs in the private sector will require considerable regulation and quality control of these products, together with appropriate management of transport and storage (WHO-Western Pacific Regional Office (WHO-WPRO), USAID | DELIVER PROJECT, Foundation for Innovative New Diagnostics (FIND), Roll Back Malaria Partnership & President’s Malaria Initiative (PMI) (2009) to ensure adequate performance of RDTs. A further requirement is training of private healthcare providers in test preparation, correct interpretation of results and case management of both positive and negative results. Despite many challenges, experience with RDT implementation at the community level shows that this is possible (Rennie et al. 2007; Harvey et al. 2008). Other measures to ensure adherence to RDT results and sufficient motivation to private providers to comply with good practice must also be addressed (Mbonye et al. 2010).

Strong public sector engagement will be needed throughout the process to ensure product quality and adherence to guidelines. Enabling the use of public sector resources to expand quality control and training to benefit malaria case management in the private sector presents potential political and legal challenges. A review of regulatory processes governing private health sector activities may be required in addition to ensure harmonization between the two sectors.

In conclusion, this preliminary enquiry provides a snapshot of RDT availability in privately run healthcare facilities in selected countries. Far more extensive studies are required to delineate private sector needs, inform public policy and ensure appropriate malaria diagnosis and treatment in the private sector. The results of such studies are likely to be very country-specific. Nevertheless, the challenges associated with establishing the routine use of RDTs in settings outside of the public sector must be tackled, as the distribution of RDTs and ACTs must occur hand in hand to ensure effective case management of febrile disease.

Acknowledgements

  1. Top of page
  2. Summary
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. References

We thank the data collection teams in Nigeria, The Philippines, Senegal, Tanzania, Peru and the Central African Republic for their participation in this study. We also thank Iveth Gonzalez for review of the results, Beatrice Gordis and Heidi Hopkins for comments on the manuscript. The study was funded by FIND (Foundation for Innovative New Diagnostics), an independent non-profit foundation with headquarters in Geneva, Switzerland, and with field offices in Uganda and India, through a grant from the Bill and Melinda Gates Foundation.

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  1. Top of page
  2. Summary
  3. Introduction
  4. Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. References
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