World Health Organization, 2022. World Malaria Report 2022. Geneva, Switzerland: WHO.
Bhatt S et al., 2015. The effect of malaria control on Plasmodium falciparum in Africa between 2000 and 2015. Nature 526: 207–211.
Askling HH et al.; European Society for Clinical Microbiology and Infectious Diseases Study Group on Clinical Parasitology, 2012. Management of imported malaria in Europe. Malar J 11: 328.
Kang SY et al., 2018. Spatio-temporal mapping of Madagascar’s Malaria Indicator Survey results to assess Plasmodium falciparum endemicity trends between 2011 and 2016. BMC Med 16: 71.
Howes RE, Mioramalala SA, Ramiranirina B, Franchard T, Rakotorahalahy AJ, Bisanzio D, Gething PW, Zimmerman PA, Ratsimbasoa A, 2016. Contemporary epidemiological overview of malaria in Madagascar: Operational utility of reported routine case data for malaria control planning. Malar J 15: 502.
Beadle C, Long GW, McElroy PD, Hoffman SL, Weiss WR, Maret SM, Oloo AJ, 1994. Diagnosis of malaria by detection of Plasmodium falciparum HRP-2 antigen with a rapid dipstick antigen-capture assay. Lancet 343: 564–568.
Gwer S, Newton CRJC, Berkley JA, 2007. Over-diagnosis and co-morbidity of severe malaria in African children: A guide for clinicians. Am J Trop Med Hyg 77: 6–13.
Leslie T, Mikhail A, Mayan I, Anwar M, Bakhtash S, Nader M, Chandler C, Whitty CJ, Rowland M, 2012. Overdiagnosis and mistreatment of malaria among febrile patients at primary healthcare level in Afghanistan: Observational study. BMJ 345: e4389.
World Health Organization, 2014. Policy Brief on Malaria Diagnostics in Low-Transmission Settings. Geneva, Switzerland: WHO.
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. Geneva, Switzerland: WHO.
Dowling MAC, Shute GT, 1966. A comparative study of thick and thin blood films in the diagnosis of scanty malaria parasitaemia. Bull World Health Organ 34: 249–267.
World Health Organization, 2016. Malaria Microscopy Quality Assurance Manual, Version 2. Geneva, Switzerland: WHO.
Gillet P et al., 2011. Prozone in malaria rapid diagnostics tests: How many cases are missed? Malar J 10: 166.
Berhane A, Russom M, Bahta I, Hagos F, Ghirmai M, Uqubay S, 2017. Rapid diagnostic tests failing to detect Plasmodium falciparum infections in Eritrea: An investigation of reported false negative RDT results. Malar J 16: 105.
Berzosa P et al., 2018. Comparison of three diagnostic methods (microscopy, RDT, and PCR) for the detection of malaria parasites in representative samples from Equatorial Guinea. Malar J 17: 333.
Ugah UI, Alo MN, Owolabi JO, Okata-Nwali OD, Ekejindu IM, Ibeh N, Elom MO, 2017. Evaluation of the utility value of three diagnostic methods in the detection of malaria parasites in endemic area. Malar J 16: 189.
World Health Organization, 2016. Giemsa Staining of Malaria Blood Films. Geneva, Switzerland: WHO.
World Health Organization, 2016. Malaria Parasite Counting. Geneva, Switzerland: WHO.
Snounou G, Beck HP, 1998. The use of PCR genotyping in the assessment of recrudescence or reinfection after antimalarial drug treatment. Parasitol Today 14: 462–467.
Färnert A et al., 2014. Epidemiology of malaria in a village in the Rufiji River Delta, Tanzania: Declining transmission over 25 years revealed by different parasitological metrics. Malar J 13: 459.
Nkumama IN, O’Meara WP, Osier FHA, 2017. Changes in malaria epidemiology in Africa and new challenges for elimination. Trends Parasitol 33: 128–140.
Gendrot M, Madamet M, Fonta I, Benoit N, Amalvict R, Mosnier J, Pradines B; French National Reference Centre for Imported Malaria Study Group, 2022. Comparative assessment of the sensitivity of ten commercial rapid diagnostic test kits for the detection of Plasmodium. Diagnostics 12: 2240.
World Health Organization, 2017. Malaria Rapid Diagnostic Test Performance: Results of WHO Product Testing of Malaria RDTS: Round 7 (2016–2017). Geneva, Switzerland: WHO.
Mayxay M, Pukrittayakamee S, Chotivanich K, Looareesuwan S, White NJ, 2001. Persistence of Plasmodium falciparum HRP-2 in successfully treated acute falciparum malaria. Trans R Soc Trop Med Hyg 95: 179–182.
Grandesso F, Nabasumba C, Nyehangane D, Page A-L, Bastard M, De Smet M, Boum Y, Etard J-F, 2016. Performance and time to become negative after treatment of three malaria rapid diagnostic tests in low and high malaria transmission settings. Malar J 15: 496.
Kiemde F, Bonko MDA, Tahita MC, Lompo P, Rouamba T, Tinto H, Van Hensbroek MB, Mens PF, Schallig HDFH, 2017. Accuracy of a Plasmodium falciparum specific histidine-rich protein 2 rapid diagnostic test in the context of the presence of non-malaria fevers, prior anti-malarial use and seasonal malaria transmission. Malar J 16: 294.
Shankar H, Singh MP, Phookan S, Singh K, Mishra N, 2021. Diagnostic performance of rapid diagnostic test, light microscopy and polymerase chain reaction during mass survey conducted in low and high malaria-endemic areas from two North-Eastern states of India. Parasitol Res 120: 2251–2261.
Bwire GM, Ngasala B, Kilonzi M, Mikomangwa WP, Felician FF, Kamuhabwa AAR, 2019. Diagnostic performance of CareStartTM malaria HRP2/pLDH test in comparison with standard microscopy for detection of uncomplicated malaria infection among symptomatic patients, Eastern Coast of Tanzania. Malar J 18: 354.
Past two years | Past Year | Past 30 Days | |
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Abstract Views | 1243 | 1243 | 528 |
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Malaria remains a significant public health concern in Madagascar. The WHO recommends using parasitological methods to confirm Plasmodium infection before treatment. This study evaluated the performance of two rapid diagnostic tests (RDTs), Bioline™ Malaria Ag Pf/Pan (Abbott Point of Care, Princeton, NJ) and Bioline™ Malaria Ag Pf/Pv (Abbott Point of Care, Princeton, NJ), compared with microscopy and polymerase chain reaction (PCR) as reference methods. A prospective, diagnostic performance study was conducted in two malaria-endemic districts with different epidemiological contexts: Ifanadiana (Plasmodium falciparum [P. falciparum] transmission) and Mandoto (Plasmodium vivax transmission). Symptomatic patients and asymptomatic individuals aged 3–81 years were enrolled between April and July 2023. Finger prick blood samples were used for RDTs, Giemsa-stained blood films, and molecular analysis. Among 675 participants (401 symptomatic, 274 asymptomatic), the performance for detecting P. falciparum and non-falciparum/vivax malaria in symptomatic patients for Bioline™ Malaria Ag Pf/Pan was 96.5% (95% CI: 93.4–98.4%) and 91.5% (95% CI: 82.5–96.8%) sensitivity and 76.0% (95% CI: 64.7–85.1%) specificity, and the performance for Bioline™ Malaria Ag Pf/Pv was 95.0% and 91.5% sensitivity and 76.0% specificity. In asymptomatic individuals, the performance was 90.3% (95% CI: 83.4–95.0%) and 33.3% (95% CI: 4.3–77.7%) sensitivity and 85.4% (95% CI: 78.9–90.6%) specificity for Bioline™ Malaria Ag Pf/Pan and 80.6% (95% CI: 80.1–93.1%) and 0% (95% CI: 0–84.2%) sensitivity and 86.0% (95% CI: 79.7–91.0%) and 86.1% (95% CI: 79.7–91.0%) specificity for Bioline™ Malaria Ag Pf/Pv. Rapid diagnostic test performance varies with local epidemiology in symptomatic patients. The results emphasize the need for careful consideration of RDT use based on local epidemiology and clinical context. Both RDTs could be used when microscopy and PCR are unavailable.
Financial support: This study was supported by
Disclosures: All data used to draw the conclusions of the study are provided in the manuscript. The data are available from the National Center for Pharmaceutical Research and Applications and NMCP. This study is part of the quality control monitoring of the RDT at the NMCP. Clear consent was systematically collected from the participating participants. This study received ethical approval from the ethics committee (reference: CERBM IORG0000851 N120 MSANP/SG/AMM/CERBM). Participation in the study was voluntary. For children, written informed consent was obtained from the tutor, school director, or village chief, ensuring proper authorization from the relevant authorities. Data collected from the participants were kept strictly confidential and used only for research purposes. All positive malaria cases identified by RDTs received immediate attention and treatment in full compliance with the established national malaria treatment guidelines. This study was conducted as part of the periodic evaluations of malaria RDTs by the NMCP in Madagascar.
Authors’ contributions: This study was conceived and designed by A. Ratsimbasoa, M. A. Rakotoarisoa, T. A. Rakotomanga, and R. Rakotosaona, who also wrote the study protocol. A. Razanatsila, A. Rakotondrandriana, and H. Rabarisoa participated in data collection. A. Ratsimbasoa and O. Raobela were the country’s principal investigators of the study and supported project implementation. Laboratory analyses were performed by M. A. Rakotoarisoa, J. Fenomanana, M. Kialozafy, A. M. Andrianarivelo and T. A. Rakotomanga. Data analysis was performed by A. Ratsimbasoa, R. Rakotosaona, F.C. Andrianaivoniaina, D. Menard, and M. A. Rakotoarisoa All authors had full access to all data in the study. A. Ratsimbasoa, R. Rakotosaona, J. Salava, D. Menard, and M. A. Rakotoarisoa interpreted the results. R. Rakotosaona, M. A. Rakotoarisoa, D. Menard, and A. Ratsimbasoa drafted the manuscript, and all authors participated in the critical revision of the manuscript for important intellectual content. All the authors have agreed to the submission of this manuscript for publication.
Current contact information: Malalanandrianina A. Rakotoarisoa, National Center for Pharmaceutical Research and Applications, Antananarivo, Madagascar, and Faculty of Medicine, University of Antananarivo, Antananarivo, Madagascar, E-mail: arimalala11@gmail.com. Tovo A. Rakotomanga and Andry M. Andrianarivelo, Malagasy Medical Analysis Laboratory, Antananarivo, Madagascar, E-mails: tovoangelo@yahoo.fr and andrimaharo@gmail.com. Jocia Fenomanana, Faculty of Medicine, University of Fianarantsoa, Fianarantsoa, Madagascar, E-mail: jfenomanana@yahoo.fr. Laurent Musango, World Health Organization, Antananarivo, Madagascar, E-mail: musangol@who.int. Oméga Raobela, National Malaria Control Program, Antananarivo, Madagascar, E-mail: oraobela@gmail.com. Julien Salava, Faculty of Economics, Management and Sociology, University of Antananarivo, Antananarivo, Madagascar, E-mail: razily.s@gmail.com. Maximilienne Kialozafy, Fanambinantsoa C. Andrianaivoniaina, and Antsa Rakotondrandriana, National Center for Pharmaceutical Research and Applications, Antananarivo, Madagascar, E-mails: kialozienne@gmail.com, fanambinantsoaclaude@gmail.com, and antsainao@gmail.com. Fanirisoa Rasolozakandrainibe, Faculty of Medicine, University of Fianarantsoa, Fianarantsoa, Madagascar, E-mail: rasolozakandrainibefanirisoa@gmail.com. Vatsiharizandry Mandrosovololona, World Health Organization, Antananarivo, Madagascar, E-mail: vatsyarija@yahoo.fr. Armel Razanatsila and Hajalalaina Rabarisoa, Faculty of Medicine, University of Antananarivo, Antananarivo, Madagascar, E-mails: razanatsilaarmel@gmail.com and hajarabarisoa@gmail.com. Didier Menard, Pathogens Host Arthropods Vectors Interactions Unit, University of Strasbourg, Strasbourg, France; Laboratory of Parasitology and Medical Mycology, Centre Hospitalier Universitaire Strasbourg, Strasbourg, France; Malaria Parasite Biology and Vaccines Unit, Institut Pasteur, Université Paris Cité, Paris, France; and Institut Universitaire de France, Paris, France; E-mails: dmenard@unistra.fr or dmenard@pasteur.fr. Rianasoambolanoro Rakotosaona, National Center for Pharmaceutical Research and Applications, Ambodivoanjo, Antananarivo, Madagascar, and Laboratory of Food Science and Health Research, École Supérieure Polytechnique, University of Antananarivo, Antananarivo, Madagascar, E-mail: riana54r@gmail.com. Arsène Ratsimbasoa, National Center for Pharmaceutical Research and Applications, Antananarivo, Madagascar, and Faculty of Medicine, University of Fianarantsoa, Fianarantsoa, Madagascar, E-mail: aratsimbasoa@gmail.com.
World Health Organization, 2022. World Malaria Report 2022. Geneva, Switzerland: WHO.
Bhatt S et al., 2015. The effect of malaria control on Plasmodium falciparum in Africa between 2000 and 2015. Nature 526: 207–211.
Askling HH et al.; European Society for Clinical Microbiology and Infectious Diseases Study Group on Clinical Parasitology, 2012. Management of imported malaria in Europe. Malar J 11: 328.
Kang SY et al., 2018. Spatio-temporal mapping of Madagascar’s Malaria Indicator Survey results to assess Plasmodium falciparum endemicity trends between 2011 and 2016. BMC Med 16: 71.
Howes RE, Mioramalala SA, Ramiranirina B, Franchard T, Rakotorahalahy AJ, Bisanzio D, Gething PW, Zimmerman PA, Ratsimbasoa A, 2016. Contemporary epidemiological overview of malaria in Madagascar: Operational utility of reported routine case data for malaria control planning. Malar J 15: 502.
Beadle C, Long GW, McElroy PD, Hoffman SL, Weiss WR, Maret SM, Oloo AJ, 1994. Diagnosis of malaria by detection of Plasmodium falciparum HRP-2 antigen with a rapid dipstick antigen-capture assay. Lancet 343: 564–568.
Gwer S, Newton CRJC, Berkley JA, 2007. Over-diagnosis and co-morbidity of severe malaria in African children: A guide for clinicians. Am J Trop Med Hyg 77: 6–13.
Leslie T, Mikhail A, Mayan I, Anwar M, Bakhtash S, Nader M, Chandler C, Whitty CJ, Rowland M, 2012. Overdiagnosis and mistreatment of malaria among febrile patients at primary healthcare level in Afghanistan: Observational study. BMJ 345: e4389.
World Health Organization, 2014. Policy Brief on Malaria Diagnostics in Low-Transmission Settings. Geneva, Switzerland: WHO.
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. Geneva, Switzerland: WHO.
Dowling MAC, Shute GT, 1966. A comparative study of thick and thin blood films in the diagnosis of scanty malaria parasitaemia. Bull World Health Organ 34: 249–267.
World Health Organization, 2016. Malaria Microscopy Quality Assurance Manual, Version 2. Geneva, Switzerland: WHO.
Gillet P et al., 2011. Prozone in malaria rapid diagnostics tests: How many cases are missed? Malar J 10: 166.
Berhane A, Russom M, Bahta I, Hagos F, Ghirmai M, Uqubay S, 2017. Rapid diagnostic tests failing to detect Plasmodium falciparum infections in Eritrea: An investigation of reported false negative RDT results. Malar J 16: 105.
Berzosa P et al., 2018. Comparison of three diagnostic methods (microscopy, RDT, and PCR) for the detection of malaria parasites in representative samples from Equatorial Guinea. Malar J 17: 333.
Ugah UI, Alo MN, Owolabi JO, Okata-Nwali OD, Ekejindu IM, Ibeh N, Elom MO, 2017. Evaluation of the utility value of three diagnostic methods in the detection of malaria parasites in endemic area. Malar J 16: 189.
World Health Organization, 2016. Giemsa Staining of Malaria Blood Films. Geneva, Switzerland: WHO.
World Health Organization, 2016. Malaria Parasite Counting. Geneva, Switzerland: WHO.
Snounou G, Beck HP, 1998. The use of PCR genotyping in the assessment of recrudescence or reinfection after antimalarial drug treatment. Parasitol Today 14: 462–467.
Färnert A et al., 2014. Epidemiology of malaria in a village in the Rufiji River Delta, Tanzania: Declining transmission over 25 years revealed by different parasitological metrics. Malar J 13: 459.
Nkumama IN, O’Meara WP, Osier FHA, 2017. Changes in malaria epidemiology in Africa and new challenges for elimination. Trends Parasitol 33: 128–140.
Gendrot M, Madamet M, Fonta I, Benoit N, Amalvict R, Mosnier J, Pradines B; French National Reference Centre for Imported Malaria Study Group, 2022. Comparative assessment of the sensitivity of ten commercial rapid diagnostic test kits for the detection of Plasmodium. Diagnostics 12: 2240.
World Health Organization, 2017. Malaria Rapid Diagnostic Test Performance: Results of WHO Product Testing of Malaria RDTS: Round 7 (2016–2017). Geneva, Switzerland: WHO.
Mayxay M, Pukrittayakamee S, Chotivanich K, Looareesuwan S, White NJ, 2001. Persistence of Plasmodium falciparum HRP-2 in successfully treated acute falciparum malaria. Trans R Soc Trop Med Hyg 95: 179–182.
Grandesso F, Nabasumba C, Nyehangane D, Page A-L, Bastard M, De Smet M, Boum Y, Etard J-F, 2016. Performance and time to become negative after treatment of three malaria rapid diagnostic tests in low and high malaria transmission settings. Malar J 15: 496.
Kiemde F, Bonko MDA, Tahita MC, Lompo P, Rouamba T, Tinto H, Van Hensbroek MB, Mens PF, Schallig HDFH, 2017. Accuracy of a Plasmodium falciparum specific histidine-rich protein 2 rapid diagnostic test in the context of the presence of non-malaria fevers, prior anti-malarial use and seasonal malaria transmission. Malar J 16: 294.
Shankar H, Singh MP, Phookan S, Singh K, Mishra N, 2021. Diagnostic performance of rapid diagnostic test, light microscopy and polymerase chain reaction during mass survey conducted in low and high malaria-endemic areas from two North-Eastern states of India. Parasitol Res 120: 2251–2261.
Bwire GM, Ngasala B, Kilonzi M, Mikomangwa WP, Felician FF, Kamuhabwa AAR, 2019. Diagnostic performance of CareStartTM malaria HRP2/pLDH test in comparison with standard microscopy for detection of uncomplicated malaria infection among symptomatic patients, Eastern Coast of Tanzania. Malar J 18: 354.
Past two years | Past Year | Past 30 Days | |
---|---|---|---|
Abstract Views | 1243 | 1243 | 528 |
Full Text Views | 40 | 40 | 18 |
PDF Downloads | 55 | 55 | 24 |