Importance of quality assurance testing of malaria rapid diagnostic test in the case management of malaria
Keywords:
Quality assurance, Quality control panels, Malaria, Rapid diagnostic testsAbstract
Prompt and rapid diagnosis of malaria has gained importance in health programmes in endemic countries, and recognition of the importance of early, correct treatment to the reduction in malaria morbidity and mortality. Blood-based diagnosis using lateral-flow immunochromatographic tests, commonly called rapid diagnostics tests (RDTs), offer great promise in extending rapid diagnosis to areas where traditional microscopy is not accessible. Large-scale operational use has raised questions about the accuracy of current RDT technology in tropical conditions. As utilization of RDTs has increased rapidly in the last few years, there is a clear and urgent need to address issues on quality performance and appropriateness of use, particularly in remote endemic areas. The need for Quality Assurance (QA) systems to maintain the quality of microscopy diagnosis of malaria is well established but the extent of implementation varies widely. Quality assurance process must become an integral part of RDT budgets, procurement and implementation plans. Responsibility for overseeing QA processes, extending from post purchase testing of RDTs to training and supervision of users and control of storage and transport, should be clearly defined and coordinated from a central level. A system of regional and referral laboratories, based on standard operating procedures would test RDTs after purchase and for the duration of shelf-life using quality control (QC) panels prepared from wild-type parasites. The use of positive control wells (PCW) containing recombinant antigens would assist in assuring the performance of RDTs in the field and this would assist in the parasite-base confirmation and in the case management of malaria. Quality assurance processes must be transparent, and good communication with manufacturers and end-users during QA development is necessary.
References
Baker, J., McCarthy, J., Gatton, M., Kyle, D.E., Belizario, V., Luchavez, J., Bell, D., Cheng, Q., 2005. Genetic diversity of Plasmodium falciparum histidine-rich protein-2 (PfHRP2) and its effects on the performance of PfHRP-2 based rapid diagnostic tests. J. Infect. Dis., 192, 870-877.
Bell, D., Wongsrichanalai, C., Barnwell, J.W., 2006. Ensuring quality and access for malaria diagnosis; how can it be achieved? Nat. Rev. Microbiol., 4, S7-S20.
Bossuyt, P.M., Van Esbroeck, M., Jacobs, J., 2003. Towards complete and reporting of studies of diagnostic accuracy the STARD initiative. BMJ, 326, 41-44.
Chanthap, R.E., Gils, A.S., Cheng, A., Bell, D., 2010. What is the precision of rapid diagnostic teste for malaria. International Child Health Review Collaboration. http://www.ichrc.int/
Chiodini, P.L., Katherine, B., Pernille, J., John, W.B., Katherine, K.G., Jenny, L., Anthony, H.M., Audie, C., David, B., 2007. The heat stability of Plasmodium lactate dehydrogenase-based and histidine-rich protein 2-based malaria rapid diagnostic tests. Transaction of the Royal Society of Tropical Medicine and Hygiene, 101, 331-337.
Coleman, R.E., Sattabongkot, J., Promstaporm, S., Maneechai, N., Khuntirat, B., 2006. Comparison of PCR and microscopy for the detection of asymptomatic malaria in a plasmodium falciparum/vivax endemic area in Thailand. Malaria J., 5, 121.
Eisen, M.E., David, R.C., Thor, G.T., Kojo, K., Spencer, P., 2000. A longitudinal study of type-specific antibody responses to Plasmodium falciparum Merozoite Surface Protein1 in an area of unstable Malaria in Sudan. J. Immunol., 161, 347-359.
Gamboa, R.O., Forney, J.R., Wongscrichanalai, C., Magill, A.J., 2003. Devices for rapid diagnosis of malaria: Evaluation of prototype assays that detect Plasmodium falciparum histidine – rich protein 2 and a Plasmodium vivax - specific antigen. J. Clin. Microbiol., 41, 2358-2366.
Gersti, G.A., Zhong, K.J., Loregrove, F.E., Graham, C.M., Jain, K.C., 2010. Evaluation of the Binax NOW ICT Test versus polymerase chain reaction and microscopy for the detection of malaria in returning travelers. Am. J. Trop. Med. Hyg., 69, 598-592.
Huong, N.M., Davis, T.M., Hewitt, S., 2002. Comparison of three antigen detection methods for diagnosis and therapeutic monitoring of malaria: A field study from Southern Vietnam. Trop. Med. Int. Health, 7, 304-308.
Jorgenson, P., Chantap, L., Rebueno, A., Tsuyuoka, R., Bell, D., 2006. Malaria rapid diagnostic tests in tropical climates: The need for cool chain. Am. J. Trop. Med. Hyg., 74, 750-754.
Lon, C., Mark, E.R., Shelley, A.E., 2005. Clinical features cannot predict a diagnosis of malaria or differentiate the infecting species in children living in an area of low transmission. Trans. R. Soc. Trop. Med. Hyg., 92, 45-49.
Luchavez, J., Lintag, M.E., Coll-Back, M., Baik, F., Bell, D., 2007. An assessment of various blood collection and transfer methods used for malaria rapid diagnostic test. Malaria J., 6, 149.
Mayxay, M., Newton, P.N., Yeung, S., Pongvongsa, T., White, N.J., 2004. Short communication: An assessment of the use of malaria rapid test by village health volunteers in rural Laos. Trop. Med. Int. Health, 9, 325-329.
McMorrow, D.P., Kawamoto, F., Lin, K., Laoboonchai, A., Wongsrichanalai, C., 2008. A comparism of two rapid immunochromatographic tests to expert microscopy in the diagnosis of malaria. Acta Trop., 82, 51-59.
Mengistu, C.D., Burges, D.C., Taylor, H.J., Kain, K.C., 2003. Evaluation of a rapid and inexpensive dipstick assay for the diagnosis of Plasmodium falciparum malaria. Bull world Health Oragan, 77, 553-9.
Moody, A., 2002. Rapid diagnostic tests for malaria parasite. Clin. Microbiol. Rev., 15(1), 66-78.
Moody, A., Hunt-Cooke, A., Gabbett, E., Chiodini, P., 2000. Performance of the OptiMAL malaria antigen capture dipstick for malaria diagnosis and treatment monitoring at the hospital for Tropical Diseases, London. Br. J. Haematol., 109, 891-894.
Nicastri, O.W., Andrew, A.A., Winston, A., Stella, B., Jonathan, K.S., 2009. Short report: Detection of Plasmodium falciparum Histidine-rich protein II in saliva of a malaria patients. Am. J. Trop. Med. Hyg., 78(5), 733-735.
Oduola, A.M., Fawole, O.I., Onadeko, M.O., 2005. Plasmodium falciparum evaluation of lactate dehyrodegenase in monitoring therapeutic responses to standard antimalaria drugs in Nigeria. Exp. Parasitol., 87, 283-289.
Palmer, C.J., Lindo, J.F., Klaskala, W.I., 1999. Evaluation of the OptiMAL test for rapid diagnosis of Plasmodium vivax and Plasmodium falciparum malaria. J. Clin. Microbiol., 36(1), 203-206.
Perkin and Bells, 2008. Evaluation of the ICT malaria p.f/p.v and the Optimal rapid diagnostic test for malaria in febrile returned travelers. J. Clin. Microbiol., 40, 4166-4171.
Pologe, L.G., Ravetch, J.V., 1988. Large deletions result from breakage and healing of P. falciparum chromosomes. Cell, 55, 869-874.
Rennie, W., Phetsouvanh, R., Lupisan, S., Vanisaveth, V., Hongvanthong, B., Phompida, S., Alday, P., Fulache, M., Lumagui, R., Jorgensen, P., Bell, D., Harvey, S., 2007. Minimising human error in malaria rapid diagnosis: Clarity of written instructions and health worker performance. Trans. R. Soc. Trop. Med. Hyg., 101, 9-18.
Richter, Y.A., Rwegoshora, R.T., Tenu, F., Massaga, J.J., Mboera, L.E., Magesa, S.M., 2004. The performance of health laboratories and the quality of malaria diagnosis in six districts of Tanzania. Ann. Trop. Med. Parasitol., 104, 123-135.
Tavrow, P., Knebel, E., Cogswell, L., 2000. Using quality design to improve malaria rapid diagnostic tests in Malawi. Operations Research Results, 1, 4.
Wanji, A.L., Iqbal, J., Sher, A., Rab, A., 2008. Plasmodium falciparum histidine-rich protein 2- based immunocapture diagnostic assay for malaria: Cross-reactivity with rheumatoid factors. J. Clin. Microbiol., 38, 1184-1186.
Wongsrichalani, A.S., Whitty, C.J.M., Amstrong, M., Behrens, R.H., 2000. Self-testing for falciparum malaria with antigen-capture cards by travelers with Symptoms of malaria. Am. J. Trop. Med. Hyg., 63, 295-297.
Wongsrichanalai, C., Barcus, M.J., Muth, S., Sutamihardja, A., Wernsdorfer, W.H., 2007. A review of malaria diagnostic tools: microscopy and rapid diagnostic test (RDT). Am. J. Trop. Med. Hyg., 77, 119-127.
World Health Organization, 2000. New perspective: Malaria diagnosis. Report of a joint WHO/USAID informal consultation 25-27 October 1999. World Organization.
World Health Organization, 2000a. Approaches to the diagnosis of malaria. In: Malaria diagnosis. Report of a joint WHO/USAID informal consultation, 10-18.
World Health Organization, 2003. Malaria rapid diagnosis, Making it Work. RS/2003/GE/05(PHL).
World Health Organization, 2004. Rapid diagnostic tests for malaria: Methods manual for laboratory quality control testing. Version 2. World Health Organization, Manila.
World Health Organization, 2005. Interim notes on selection of types of malaria rapid diagnostic tests in relation to the occurrence of different parasite species. Regional office for Africa and Western Pacific.
World Health Organization, 2006. The role of laboratory diagnosis to support malaria disease management. Focus on the use of rapid diagnostic tests in areas of high transmission. Report of a WHO technical consultation. Geneva, Switzerland.
World Health Organization, 2008. Methods manual for laboratory quality control testing of malaria rapid diagnostic tests. UNICEF/UNDP/World Bank/WHO. Special Programme for research and training in tropical disease (TDR). Foundation for Innovative Diagnosis (FIND) 1216 Geneva, Switzerland.
World Health Organization: Malaria Rapid Diagnostic Test Performance; Results of WHO product testing of malaria RDTs: Round 2 (2009). 2010. http://www.finddiagnostics.org/resource-centre/reports_brochures/malaria diagnostic-test-report-round2.html
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