Performance of the Bioline™ Malaria Ag Pf/Pan and Bioline™ Malaria Ag Pf/Pv for Malaria Diagnostics: Madagascar In-Country Evaluation

Financial support: This study was supported by Abbott Rapid Dx Galway D10058520.

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.