Ensuring quality and access for malaria diagnosis: how can it be achieved? (original) (raw)
Font, F. et al. Diagnostic accuracy and case management of clinical malaria in the primary health services of a rural area in south-eastern Tanzania. Trop. Med. Int. Health6, 423–428 (2001). ArticleCASPubMed Google Scholar
Chandramohan, D. et al. A clinical algorithm for the diagnosis of malaria: results of an evaluation in an area of low endemicity. Trop. Med. Int. Health6, 505–510 (2001). ArticleCASPubMed Google Scholar
Luxemburger, C. et al. 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 (1998). ArticleCASPubMed Google Scholar
Armstrong-Schellenberg, J. R. M., Smith, T., Alonso, P. L. & Hayes, R. J. What is clinical malaria? Finding case definitions for field research in highly endemic areas. Parasitol. Today10, 439–442 (1994). Illustrates the poor specificity of symptom-based diagnosis of malaria in endemic countries. Article Google Scholar
Smith, T., Hurt, N., Teuscher, T. & Tanner, M. Is fever a good sign for clinical malaria in surveys of endemic communities? Am. J. Trop. Med. Hyg.52, 306–310 (1995). ArticleCASPubMed Google Scholar
Chandramohan, D., Jaffar, S. & Greenwood, B. Use of clinical algorithms for diagnosing malaria. Trop. Med. Int. Health7, 45–52 (2002). ArticlePubMed Google Scholar
Reyburn, H. et al. Overdiagnosis of malaria in patients with severe febrile illness in Tanzania: a prospective study. BMJ329, 1212 (2004). ArticlePubMedPubMed Central Google Scholar
Bojang, K. A., Obaro, S., Morison, L. A. & Greenwood, B. M. A prospective evaluation of a clinical algorithm for the diagnosis of malaria in Gambian children. Trop. Med. Int. Health5, 231–236 (2000). ArticleCASPubMed Google Scholar
Kallander, K., Nsungwa-Sabiiti, J. & Peterson, S. Symptom overlap for malaria and pneumonia — policy implications for home management strategies. Acta Trop.90, 211–214 (2004). ArticlePubMed Google Scholar
Greenwood, B. M. et al. Mortality and morbidity from malaria among children in a rural area of The Gambia, West Africa. Trans. R. Soc. Trop. Med. Hyg.81, 478–486 (1987). ArticleCASPubMed Google Scholar
Berkley, J. A. et al. Use of clinical syndromes to target antibiotic prescribing in seriously ill children in malaria endemic area: observational study. BMJ330, 995 (2005). ArticlePubMedPubMed Central Google Scholar
Carcillo, J. A. Reducing the global burden of sepsis in infants and children: a clinical practice research agenda. Pediatr. Crit. Care Med.6, S157–S164 (2005). Describes the burden of febrile disease, including non-malarial febrile infections, and the potential benefit of rapid diagnosis in their management. ArticlePubMed Google Scholar
Peters, R. P. et al. A prospective study of bloodstream infections as cause of fever in Malawi: clinical predictors and implications for management. Trop. Med. Int. Health9, 928–934 (2004). ArticlePubMed Google Scholar
WHO. World Malaria Report 2005 (WHO and UNICEF, Geneva, 2005). The most comprehensive data set on currently reported malaria and case management. Greatly under-estimates the burden, but generally reflects cases within the current reach of organized government health services that might be readily accessible to rapid diagnosis.
Hay, S. I., Guerra, C. A., Tatem, A. J., Atkinson, P. M. & Snow, R. W. Urbanization, malaria transmission and disease burden in Africa. Nature Rev. Microbiol.3, 81–90 (2005). ArticleCAS Google Scholar
WHO. Strategic Orientation Paper on Prevention and Control of Malaria (WHO, Geneva, 2005).
WHO. Guidelines for the Treatment of Malaria (WHO, Geneva, 2006). Recently published treatment guidelines, intended to guide movement to effective, higher cost antimalarial therapies.
Kachur, S. P. et al. Prevalence of malaria parasitemia and accuracy of microscopic diagnosis in Haiti, October 1995. Rev. Panam. Salud Publica3, 35–39 (1998). An example of the evidence of the poor quality of much of the current field-based malaria microscopy. CASPubMed Google Scholar
Durrheim, D. N., Becker, P. J. & Billinghurst, K. Diagnostic disagreement — the lessons learnt from malaria diagnosis in Mpumalanga. S. Afr. Med. J.87, 1016 (1997). CASPubMed Google Scholar
Kilian, A. H. et al. Reliability of malaria microscopy in epidemiological studies: results of quality control. Trop. Med. Int. Health5, 3–8 (2000). An example of the evidence of the poor quality of much of the current field-based malaria microscopy. ArticleCASPubMed Google Scholar
Kain, K. C., Harrington, M. A., Tennyson, S. & Keystone, J. S. Imported malaria: prospective analysis of problems in diagnosis and management. Clin. Infect. Dis.27, 142–149 (1998). ArticleCASPubMed Google Scholar
Coleman, R. E. et al. Comparison of field and expert laboratory microscopy for active surveillance for asymptomatic Plasmodium falciparum and Plasmodium vivax in western Thailand. Am. J. Trop. Med. Hyg.67, 141–144 (2002). ArticlePubMed Google Scholar
O'Meara, W. P. et al. Sources of variability in determining malaria parasite density by microscopy. Am. J. Trop. Med. Hyg.73, 593–598 (2005). ArticlePubMed Google Scholar
Premji, Z., Minjas, J. N. & Shiff, C. J. Laboratory diagnosis of malaria by village health workers using the rapid manual ParaSight-F test. Trans. R. Soc. Trop. Med. Hyg.88, 418 (1994). ArticleCASPubMed Google Scholar
Shiff, C. J., Minjas, J. & Premji, Z. The ParaSight(R)-F test: a simple rapid manual dipstick test to detect Plasmodium falciparum infection. Parasitol. Today10, 494–495 (1994). ArticleCASPubMed Google Scholar
Shiff, C. J., Premji, Z. & Minjas, J. N. The rapid manual ParaSight-F test. A new diagnostic tool for Plasmodium falciparum infection. Trans. R. Soc. Trop. Med. Hyg.87, 646–648 (1993). ArticleCASPubMed Google Scholar
Beadle, C. et al. Diagnosis of malaria by detection of Plasmodium falciparum HRP-2 antigen with a rapid dipstick antigen-capture assay. Lancet343, 564–568 (1994). ArticleCASPubMed Google Scholar
Whitty, C. J. M., Armstrong, M. & Behrens, R. H. Self-testing for falciparum malaria with antigen-capture cards by travelers with symptoms of malaria. Am. J. Trop. Med. Hyg.63, 295–297 (2000). ArticlePubMed Google Scholar
Hashizume, M. et al. Use of rapid diagnostic tests for malaria in an emergency situation after the flood disaster in Mozambique. Public Health120, 444–447 (2006). ArticleCASPubMed Google Scholar
WHO. The Use of Malaria Rapid Diagnostic Tests (WHO, Regional Office for the Western Pacific, Manila, 2004). Short guide on issues related to malaria RDT procurement and use.
WHO. Malaria Management in Complex Emergencies: an Inter-agency Field Handbook (WHO, Geneva, 2005).
D'Alessandro, U., Talisuna, A. & Boelaert, M. Editorial: should artemisinin-based combination treatment be used in the home-based management of malaria? Trop. Med. Int. Health10, 1–2 (2005). Discussion of community-based care for malaria, including a successful intervention programme based on low-cost drugs and symptom-based diagnosis. ArticleCASPubMed Google Scholar
Bell, D., Go, R., Miguel, C., Parks, W. & Bryan, J. Unequal treatment access and malaria risk in a community-based intervention program in the Philippines. Southeast Asian J. Trop. Med. Public Health36, 578–586 (2005). CASPubMed Google Scholar
Konradsen, F., Amerasinghe, P. H., Perera, D., Van der Hoek, W. & Amerasinghe, F. P. A village treatment center for malaria: community response in Sri Lanka. Soc. Sci. Med.50, 879–889 (2000). ArticleCASPubMed Google Scholar
Sirima, S. B. et al. Early treatment of childhood fevers with pre-packaged antimalarial drugs in the home reduces severe malaria morbidity in Burkina Faso. Trop. Med. Int. Health8, 133–139 (2003). ArticlePubMed Google Scholar
Kallander, K. et al. Community referral in home management of malaria in western Uganda: a case series study. BMC Int. Health Hum. Rights6, 2 (2006). ArticlePubMedPubMed Central Google Scholar
Kaseje, D. C., Spencer, H. C. & Sempebwa, E. K. Usage of community-based chloroquine treatment for malaria in Saradidi, Kenya. Ann. Trop. Med. Parasitol.81 (Suppl. 1), 111–115 (1987). ArticlePubMed Google Scholar
Ghebreyesus, T. A. et al. The community-based malaria control programme in Tigray, northern Ethiopia. A review of programme set-up, activities, outcomes and impact. Parassitologia42, 255–290 (2000). Describes a community-based programme for malaria care, including arguments for and against the introduction of ACT use at village level. CASPubMed Google Scholar
Okanurak, K. & Ruebush, T. K. Village-based diagnosis and treatment of malaria. Acta Trop.61, 157–167 (1996). ArticleCASPubMed Google Scholar
Goodman, C. A., Coleman, P. G. & Mills, A. J. Cost-effectiveness of malaria control in sub-Saharan Africa. Lancet354, 378–385 (1999). ArticleCASPubMed Google Scholar
Roll Back Malaria (RBM) Partnership. Sources and Prices for Selected Products for the Prevention, Diagnosis and Treatment of Malaria (RBM Partnership, Geneva, 2004).
Redd, S. C. et al. Usefulness of clinical case-definitions in guiding therapy for African children with malaria or pneumonia. Lancet340, 1140–1143 (1992). ArticleCASPubMed Google Scholar
Duong, S., Lim, P., Fandeur, T., Tsuyuoka, R. & Wongsrichanalai, C. Importance of protection of antimalarial combination therapies. Lancet364, 1754–1755 (2004). ArticlePubMed Google Scholar
Towie, N. Malaria breakthrough raises spectre of drug resistance. Nature440, 852–853 (2006). ArticleCASPubMed Google Scholar
Duffy, P. E. & Sibley, C. H. Are we losing artemisinin combination therapy already? Lancet366, 1908–1909 (2005). ArticlePubMed Google Scholar
Malaria R&D Alliance. Malaria Research & Development — An Assessment of Global Investment (PATH, Seattle, 2005).
Roll Back Malaria (RBM) — A Global Partnership. Roll Back Malaria Partnership. http://www.rbm.who.int (2006).
Rifkin, S. B. Paradigms lost: toward a new understanding of community participation in health programmes. Acta Trop.61, 79–92 (1996). Discusses community-based care for malaria, including a review of reasons for the failure and success of such programmes. ArticleCASPubMed Google Scholar
Tarimo, D. S., Minjas, J. N. & Bygbjerg, I. C. 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. Ann. Trop. Med. Parasitol.95, 437–444 (2001). ArticleCASPubMed Google Scholar
Gove, S. Integrated management of childhood illness by outpatient health workers: technical basis and overview. The WHO working group on guidelines for integrated management of the sick child. Bull. World Health Organ.75, (Suppl. 1), 7–24 (1997). PubMedPubMed Central Google Scholar
Cunha, M. L., Piovesan-Alves, F. & Pang, L. W. Community-based program for malaria case management in the Brazilian Amazon. Am. J. Trop. Med. Hyg.65, 872–876 (2001). ArticleCASPubMed Google Scholar
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 J. Trop. Med. Public Health28, 243–246 (1997). CASPubMed Google Scholar
Mayxay, M. et al. Short communication: an assessment of the use of malaria rapid tests by village health volunteers in rural Laos. Trop. Med. Int. Health9, 325–329 (2004). ArticlePubMed Google Scholar
Tavrow, P., Knebel, E. & Cogswell, L. Using Quality Design to Improve Malaria Rapid Diagnostic Tests in Malawi (Quality Assurance Project (QAP) for the United States Agency for International Development, Bethesda USA, 2000). Google Scholar
Funk, M., Schlagenhauf, P., Tschopp, A. & Steffen, R. MalaQuick versus ParaSight-F as a diagnostic aid in travellers' malaria. Trans. R. Soc. Trop. Med. Hyg.93, 268–272 (1999). ArticleCASPubMed Google Scholar
Trachsler, M., Schlagenhauf, P. & Steffen, R. Feasibility of a rapid dipstick antigen-capture assay for self-testing of travellers' malaria. Trop. Med. Int. Health4, 442–447 (1999). ArticleCASPubMed Google Scholar
Fryauff, D. J. et al. Performance of the OptiMAL assay for detection and identification of malaria infections in asymptomatic residents of Irian Jaya, Indonesia. Am. J. Trop. Med. Hyg.63, 139–145 (2000). ArticleCASPubMed Google Scholar
Jelinek, T., Grobusch, M. P. & Nothdurft, H. D. Use of dipstick tests for the rapid diagnosis of malaria in nonimmune travelers. J. Travel. Med.7, 175–179 (2000). ArticleCASPubMed Google Scholar
Kilian, A. H. et al. Application of the ParaSight-F dipstick test for malaria diagnosis in a district control program. Acta Trop.72, 281–293 (1999). ArticleCASPubMed Google Scholar
Mharakurwa, S., Manyame, B. & Shiff, C. J. Trial of the ParaSight-F test for malaria diagnosis in the primary health care system, Zimbabwe. Trop. Med. Int. Health2, 544–550 (1997). ArticleCASPubMed Google Scholar
Harvey, S. et al. Minimizing human error in malaria rapid diagnosis: clarity of written instructions and health worker performance. Trans. R.l Soc. Trop. Med. Hyg. (in the press).
Njau, J. D. et al. Fever treatment and household wealth: the challenge posed for rolling out combination therapy for malaria. Trop. Med. Int. Health11, 299–313 (2006). ArticleCASPubMed Google Scholar
WHO. Malaria Rapid Diagnosis: Making it Work. Meeting report 20–23 January 2003 (WHO, Manila, 2003).
Amexo, M., Tolhurst, R., Barnish, G. & Bates, I. Malaria misdiagnosis: effects on the poor and vulnerable. Lancet364, 1896–1898 (2004). ArticlePubMed Google Scholar
Wongsrichanalai, C. et al. Comparison of a rapid field immunochromatographic test to expert microscopy for the detection of Plasmodium falciparum asexual parasitemia in Thailand. Acta Trop.73, 263–273 (1999). ArticleCASPubMed Google Scholar
Gaye, O., Diouf, M., Dansokho, E. F., McLaughlin, G. & Diallo, S. Diagnosis of Plasmodium falciparum malaria using ParaSight-F, ICT malaria PF and malaria IgG CELISA assays. Parasite5, 189–192 (1998). ArticleCASPubMed Google Scholar
Quintana, M. et al. Malaria diagnosis by dipstick assay in a Honduran population with coendemic Plasmodium falciparum and Plasmodium vivax. Am. J. Trop. Med. Hyg.59, 868–871 (1998). ArticleCASPubMed Google Scholar
Forney, J. R. et al. Malaria rapid diagnostic devices: performance characteristics of the ParaSight-F device determined in a multisite field study. J. Clin. Microbiol.39, 2884–2890 (2001). ArticleCASPubMedPubMed Central Google Scholar
Iqbal, J., Khalid, N. & Hira, P. R. Comparison of two commercial assays with expert microscopy for confirmation of symptomatically diagnosed malaria. J. Clin. Microbiol.40, 4675–4678 (2002). ArticlePubMedPubMed Central Google Scholar
Wolday, D., Balcha, F., Fessehaye, G., Birku, Y. & Shepherd, A. Field trial of the RTM dipstick method for the rapid diagnosis of malaria based on the detection of Plasmodium falciparum HRP-2 antigen in whole blood. Trop. Doct.31, 19–21 (2001). ArticleCASPubMed Google Scholar
Happi, C. T. et al. Malaria diagnosis: false negative parasight-F tests in falciparum malaria patients in Nigeria. Afr. J. Med. Sci.33, 15–18 (2004). CAS Google Scholar
Baker, J. et al. Genetic diversity of Plasmodium falciparum histidine-rich protein 2 (PfHRP2) and its effect on the performance of PfHRP2-based rapid diagnostic tests. J. Infect. Dis.192, 870–877 (2005). ArticleCASPubMed Google Scholar
O'Dempsey, T. J. et al. Overlap in the clinical features of pneumonia and malaria in African children. Trans. R. Soc. Trop. Med. Hyg.87, 662–665 (1993). ArticleCASPubMed Google Scholar
WHO. Informal Consultation on Testing Methods for Malaria Rapid Diagnostic Tests, Geneva, Switzerland, 28 February–2 March, 2006 (WHO-Regional Office for the Western Pacific & Special Programme for Research and Training in Tropical Diseases (TDR), Manila, 2006). Outline of current plans by WHO and partners for malaria RDT product testing and laboratory-based quality control testing.
Nsungwa-Sabiiti, J., Tomson, G., Pariyo, G., Ogwal-Okeng, J. & Peterson, S. Community effectiveness of malaria treatment in Uganda — a long way to Abuja targets. Ann. Trop. Paediatr.25, 91–100 (2005). ArticlePubMed Google Scholar
Unger, J. P., d'Alessandro, U., De Paepe, P. & Green, A. Can malaria be controlled where basic health services are not used? Trop. Med. Int. Health11, 314–322 (2006). ArticlePubMed Google Scholar
Foster, S. Treatment of malaria outside the formal health services. J. Trop. Med. Hyg.98, 29–34 (1995). CASPubMed Google Scholar
Hamel, M. J., Odhacha, A., Roberts, J. M. & Deming, M. S. Malaria control in Bungoma District, Kenya: a survey of home treatment of children with fever, bednet use and attendance at antenatal clinics. Bull. World Health Organ.79, 1014–1023 (2001). CASPubMedPubMed Central Google Scholar
Fawole, O. I. & Onadeko, M. O. Knowledge and home management of malaria fever by mothers and care givers of under five children. West Afr. J. Med.20, 152–157 (2001). CASPubMed Google Scholar
Ibeh, C. C., Ekejindu, I. M., Ibeh, N. C., Shu, E. N. & Chukwuka, J. O. The pattern of home treatment of malaria in under-fives in south eastern Nigeria. Afr. J. Med. Sci.34, 71–75 (2005). CAS Google Scholar
Mwenesi, H., Harpham, T. & Snow, R. W. Child malaria treatment practices among mothers in Kenya. Soc. Sci. Med.40, 1271–1277 (1995). ArticleCASPubMed Google Scholar
Snow, R. W., Peshu, N., Forster, D., Mwenesi, H. & Marsh, K. The role of shops in the treatment and prevention of childhood malaria on the coast of Kenya. Trans. R. Soc. Trop. Med. Hyg.86, 237–239 (1992). ArticleCASPubMed Google Scholar
Pagnoni, F. et al. Artemisinin-based combination treatment in home-based management of malaria. Trop. Med. Int. Health10, 621–622 (2005). ArticlePubMed Google Scholar
Dondorp, A. M. et al. Fake antimalarials in Southeast Asia are a major impediment to malaria control: multinational cross-sectional survey on the prevalence of fake antimalarials. Trop. Med. Int. Health9, 1241–1246 (2004). ArticleCASPubMed Google Scholar
Amin, A. A., Snow, R. W. & Kokwaro, G. O. The quality of sulphadoxine-pyrimethamine and amodiaquine products in the Kenyan retail sector. J. Clin. Pharm. Ther.30, 559–565 (2005). ArticleCASPubMedPubMed Central Google Scholar
WHO. New Perspectives: Malaria Diagnosis. Report of a Joint WHO/USAID Informal Consultation 25–27 October 1999 (WHO, Geneva, 2000).
Mankhambo, L., Kanjala, M., Rudman, S., Lema, V. M. & Rogerson, S. J. Evaluation of the OptiMAL rapid antigen test and species-specific PCR to detect placental Plasmodium falciparum infection at delivery. J. Clin. Microbiol.40, 155–158 (2002). ArticleCASPubMedPubMed Central Google Scholar
Singh, N., Saxena, A., Awadhia, S. B., Shrivastava, R. & Singh, M. P. Evaluation of a rapid diagnostic test for assessing the burden of malaria at delivery in India. Am. J. Trop. Med. Hyg.73, 855–858 (2005). ArticlePubMed Google Scholar
Vanderjagt, T. A. et al. Short communication: comparison of the OptiMAL rapid test and microscopy for detection of malaria in pregnant women in Nigeria. Trop. Med. Int. Health10, 39–41 (2005). ArticleCASPubMed Google Scholar
Rogers, W. O., Atuguba, F., Oduro, A. R., Hodgson, A. & Koram, K. A. Clinical case definitions and malaria vaccine efficacy. J. Infect. Dis.193, 467–473 (2006). ArticlePubMed Google Scholar
Chirenda, J., Siziya, S. & Tshimanga, M. Association of HIV infection with the development of severe and complicated malaria cases at a rural hospital in Zimbabwe. Cent. Afr. J. Med.46, 5–9 (2000). CASPubMed Google Scholar
Grimwade, K. et al. Childhood malaria in a region of unstable transmission and high human immunodeficiency virus prevalence. Pediatr. Infect. Dis. J.22, 1057–1063 (2003). ArticlePubMed Google Scholar
Cohen, C. et al. Increased prevalence of severe malaria in HIV-infected adults in South Africa. Clin. Infect. Dis.41, 1631–1637 (2005). ArticlePubMed Google Scholar
WHO. WHO Technical Consultation To Review The Role Of Parasitological Diagnosis To Support Malaria Disease Management: Focus On The Use Of RDTs In Areas Of High Transmission Deploying ACT Treatments (WHO, Geneva, 2005).
Jorgensen, P., Chanthap, L., Rebueno, A., Tsuyuoka, R. & Bell, A. D. Malaria rapid diagnostic tests in tropical climates: the need for a cool chain. Am. J. Trop. Med. Hyg.74, 750–754 (2006). ArticlePubMed Google Scholar
WHO. Interim Notes on Selection of Type of Malaria Rapid Diagnostic Test in Relation to the Occurrence of Different Parasite Species: Guidance for National Malaria Control Programmes (Roll Back Malaria Department, WHO, Geneva, 2005).
Fernando, S. D., Karunaweera, N. D. & Fernando, W. P. Evaluation of a rapid whole blood immunochromatographic assay for the diagnosis of Plasmodium falciparum and Plasmodium vivax malaria. Ceylon Med. J.49, 7–11 (2004). ArticleCASPubMed Google Scholar
Kolaczinski, J. 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. Ann. Trop. Med. Parasitol.98, 15–20 (2004). ArticleCASPubMed Google Scholar
Coleman, R. E. 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. Am. J. Trop. Med. Hyg.66, 379–383 (2002). ArticlePubMed Google Scholar
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-chromographic-malaria dipstick (ICT) as a potential semi-quantitative marker of high Plasmodium falciparum parasitaemia. Parasitol. Res.94, 384–385 (2004). ArticlePubMed Google Scholar
Hernandez, E. et al. Evaluation of the OptiMal test in the diagnosis of imported malarial outbreak. Med. Trop. (Mars)61, 153–157 (2001). CAS Google Scholar
Iqbal, J., Hira, P. R., Sher, A. & Al-Enezi, A. A. Diagnosis of imported malaria by Plasmodium lactate dehydrogenase (pLDH) and histidine-rich protein 2 (PfHRP-2)-based immunocapture assays. Am. J. Trop. Med. Hyg.64, 20–23 (2001). ArticleCASPubMed Google Scholar
Ricci, L. et al. Evaluation of OptiMAL Assay test to detect imported malaria in Italy. New Microbiol.23, 391–398 (2000). CASPubMed Google Scholar
Huong, N. M. et al. Comparison of three antigen detection methods for diagnosis and therapeutic monitoring of malaria: a field study from southern Vietnam. Trop. Med. Int. Health7, 304–308 (2002). ArticlePubMed Google Scholar
Stow, N. W., Torrens, J. K. & 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. Trans. R. Soc. Trop. Med. Hyg.93, 519–520 (1999). ArticleCASPubMed Google Scholar
Mason, D. P., 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 Trop.82, 51–59 (2002). ArticlePubMed Google Scholar
Rubio, J. M. et al. Limited level of accuracy provided by available rapid diagnosis tests for malaria enhances the need for PCR-based reference laboratories. J. Clin. Microbiol.39, 2736–2737 (2001). ArticleCASPubMedPubMed Central Google Scholar
Genton, B., Hii, J., Paget, S. & Alpers, M. P. Rapid manual diagnosis of Plasmodium falciparum malaria using parasight-F dipsticks applied to human blood and urine. J. Travel Med.3, 172–173 (1996). ArticleCASPubMed Google Scholar
Coleman, R. E. et al. Short report: failure of the OptiMAL rapid malaria test as a tool for the detection of asymptomatic malaria in an area of Thailand endemic for Plasmodium falciparum and P. vivax. Am. J. Trop. Med. Hyg.67, 563–565 (2002). ArticlePubMed Google Scholar
Pattanasin, S. et al. Evaluation of a new Plasmodium lactate dehydrogenase assay (OptiMAL-IT) for the detection of malaria. Trans. R. Soc. Trop. Med. Hyg.97, 672–674 (2003). ArticleCASPubMed Google Scholar
Bossuyt, P. M. et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. BMJ326, 41–44 (2003). Outline of recommendations of STARD for diagnostic trials. ArticlePubMedPubMed Central Google Scholar
WHO. Informal Consultation On Laboratory Methods For Quality Assurance Of Malaria Rapid Diagnostic Tests; Manila, 20–22 July 2004 (WHO, Regional Office for the Western Pacific, Manila, 2004).
Bigaillon, C., Fontan, E., Cavallo, J. D., Hernandez, E. & Spiegel, A. Ineffectiveness of the Binax NOW malaria test for diagnosis of Plasmodium ovale malaria. J. Clin. Microbiol.43, 1011 (2005). ArticlePubMedPubMed Central Google Scholar
Marx, A. et al. Meta-analysis: accuracy of rapid tests for malaria in travelers returning from endemic areas. Ann. Intern. Med.142, 836–846 (2005). ArticlePubMed Google Scholar
Desakorn, V. et al. Stage-dependent production and release of histidine-rich protein 2 by Plasmodium falciparum. Trans. R. Soc. Trop. Med. Hyg.99, 517–524 (2005). ArticleCASPubMed Google Scholar
Miller, R. S., McDaniel, P. & Wongsrichanalai, C. Following the course of malaria treatment by detecting parasite lactate dehydrogenase enzyme. Br. J. Haematol.113, 558–559 (2001). ArticleCASPubMed Google Scholar
Moody, A., Hunt-Cooke, A., Gabbett, E. & Chiodini, P. Performance of the OptiMAL malaria antigen capture dipstick for malaria diagnosis and treatment monitoring at the Hospital for Tropical Diseases, London. Br. J. Haematol.109, 891–894 (2000). ArticleCASPubMed Google Scholar
Oduola, A. M. et al. Plasmodium falciparum: evaluation of lactate dehydrogenase in monitoring therapeutic responses to standard antimalarial drugs in Nigeria. Exp. Parasitol.87, 283–289 (1997). ArticleCASPubMed Google Scholar
Palmer, C. J. et al. Field evaluation of the OptiMAL rapid malaria diagnostic test during antimalarial therapy in Guyana. Trans. R. Soc. Trop. Med. Hyg.93, 517–518 (1999). ArticleCASPubMed Google Scholar
Eisen, D. P. & Saul, A. Disappearance of pan-malarial antigen reactivity using the ICT Malaria P.f/P.v kit parallels decline of patent parasitaemia as shown by microscopy. Trans. R. Soc. Trop. Med. Hyg.94, 169–170 (2000). ArticleCASPubMed Google Scholar
Mayxay, M., Pukrittayakamee, S., Chotivanich, K., Looareesuwan, S. & White, N. J. Persistence of Plasmodium falciparum HRP-2 in successfully treated acute falciparum malaria. Trans. R. Soc. Trop. Med. Hyg.95, 179–182 (2001). ArticleCASPubMed Google Scholar
Tjitra, E., Suprianto, S., McBroom, J., Currie, B. J. & Anstey, N. M. 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. J. Clin. Microbiol.39, 1025–1031 (2001). ArticleCASPubMedPubMed Central Google Scholar
Humar, A., Ohrt, C., Harrington, M. A., Pillai, D. & Kain, K. C. Parasight F test compared with the polymerase chain reaction and microscopy for the diagnosis of Plasmodium falciparum malaria in travelers. Am. J. Trop. Med. Hyg.56, 44–48 (1997). ArticleCASPubMed Google Scholar
WHO. Rapid Diagnostic Tests for Malaria: Methods Manual for Laboratory Quality Control Testing. Version 3 (WHO, Regional Office for the Western Pacific, Manila, 2006).
Lon, C. T., Alcantara, S., Luchavez, J., Tsuyuoka, R. & Bell, D. Positive control wells: a potential answer to remote-area quality assurance of malaria rapid diagnostic tests. Trans. R. Soc. Trop. Med. Hyg.99, 493–498 (2005). ArticleCASPubMed Google Scholar
Forney, J. R. 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. J. Clin. Microbiol.41, 2358–2366 (2003). ArticleCASPubMedPubMed Central Google Scholar
Kilian, A. H., Mughusu, E. B., Kabagambe, G. & von Sonnenburg, F. Comparison of two rapid, HRP2-based diagnostic tests for Plasmodium falciparum. Trans. R. Soc. Trop. Med. Hyg.91, 666–667 (1997). ArticleCASPubMed Google Scholar
Cho-Min-Naing & Gatton, M. L. Performance appraisal of rapid on-site malaria diagnosis (ICT malaria P.f/P.v test) in relation to human resources at village level in Myanmar. Acta Trop.81, 13–19 (2002). ArticleCASPubMed Google Scholar
Guthmann, J. P. et al. Validity, reliability and ease of use in the field of five rapid tests for the diagnosis of Plasmodium falciparum malaria in Uganda. Trans. R. Soc. Trop. Med Hyg.96, 254–257 (2002). ArticleCASPubMed Google Scholar
Cropley, I. M., Lockwood, D. N., 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. BMJ321, 484–485 (2000). ArticleCASPubMedPubMed Central Google Scholar
Richardson, D. C., Ciach, M., Zhong, K. J., Crandall, I. & Kain, K. C. Evaluation of the Makromed dipstick assay versus PCR for diagnosis of Plasmodium falciparum malaria in returned travelers. J. Clin. Microbiol.40, 4528–4530 (2002). ArticleCASPubMedPubMed Central Google Scholar
Leke, R. F. et al. Detection of the Plasmodium falciparum antigen histidine-rich protein 2 in blood of pregnant women: implications for diagnosing placental malaria. J. Clin. Microbiol.37, 2992–2996 (1999). CASPubMedPubMed Central Google Scholar
Singer, L. M. et al. Evaluation of a malaria rapid diagnostic test for assessing the burden of malaria during pregnancy. Am. J. Trop. Med. Hyg.70, 481–485 (2004). ArticlePubMed Google Scholar
Bell, D. R., Wilson, D. W. & Martin, L. B. 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. Am. J. Trop. Med. Hyg.73, 199–203 (2005). ArticleCASPubMed Google Scholar
Mishra, B., Samantaray, J. C., Kumar, A. & Mirdha, B. R. Study of false positivity of two rapid antigen detection tests for diagnosis of Plasmodium falciparum malaria. J. Clin. Microbiol.37, 1233 (1999). CASPubMedPubMed Central Google Scholar
Moody, A. H. & Chiodini, P. L. Non-microscopic method for malaria diagnosis using OptiMAL IT, a second-generation dipstick for malaria pLDH antigen detection. Br. J. Biomed. Sci.59, 228–231 (2002). ArticleCASPubMed Google Scholar
McKenzie, F. E., Sirichaisinthop, J., Miller, R. S., Gasser, R. A., Jr. & Wongsrichanalai, C. Dependence of malaria detection and species diagnosis by microscopy on parasite density. Am. J. Trop. Med. Hyg.69, 372–376 (2003). ArticlePubMed Google Scholar
Raghavan, K. Statistical considerations in the microscopical diagnosis of Malaria, with special reference to the role of cross-checking. Bull. World Health Organ.34, 788–791 (1966). CASPubMedPubMed Central Google Scholar
Uguen, C. et al. ParaSight-F rapid manual diagnostic test of Plasmodium falciparum infection. Bull. World Health Organ.73, 643–649 (1995). CASPubMedPubMed Central Google Scholar
Lema, O. E. et al. Comparison of five methods of malaria detection in the outpatient setting. Am. J. Trop. Med. Hyg.60, 177–182 (1999). ArticleCASPubMed Google Scholar
Craig, M. H. et al. Field and laboratory comparative evaluation of ten rapid malaria diagnostic tests. Trans. R. Soc. Trop. Med. Hyg.96, 258–265 (2002). ArticleCASPubMed Google Scholar
Tham, J. M., Lee, S. H., Tan, T. M., Ting, R. C. & Kara, U. A. 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. J. Clin. Microbiol.37, 1269–1273 (1999). CASPubMedPubMed Central Google Scholar
Bechem, N. N., Leke, R. F., Tietche, F. & Taylor, D. W. Evaluation of a rapid test for histidine rich protein 2 for diagnosis of Plasmodium falciparum infection in Cameroonian children. Trans. R. Soc. Trop. Med. Hyg.93, 46 (1999). ArticleCASPubMed Google Scholar
Erhart, L. M. et al. Hematologic and clinical indices of malaria in a semi-immune population of western Thailand. Am. J. Trop. Med. Hyg.70, 8–14 (2004). ArticlePubMed Google Scholar
Whiting, P. et al. Sources of variation and bias in studies of diagnostic accuracy: a systematic review. Ann. Intern. Med.140, 189–202 (2004). ArticlePubMed Google Scholar
Kooij, T. W. A., Janse, C. W. & Waters, A. P. Plasmodium post genomics: better the bug you know? Nature Rev. Microbiol.4, 344–357 (2006). ArticleCAS Google Scholar