Madagascar In-Country Evaluation for Bioline™ Malaria Ag Pf/Pan and Bioline™ Malaria Ag

Abstract

Abstract Background: Malaria remains a significant public health challenge in Madagascar. The World Health Organization (WHO) recommends confirming the presence of parasites through parasitological methods before initiating malaria treatment. Microscopy and rapid diagnostic tests (RDTs) are primary diagnostic methods. This study aimed to evaluate the diagnostic performance of two RDTs: Bioline™ Malaria Ag Pf/Pan and Bioline™ Malaria Ag Pf/Pv by comparing them to microscopic diagnosis, with polymerase chain reaction (PCR) serving as the designated reference standard. Methods: Madagascar-based, from two malaria-endemic districts: Ifanadiana and Mandoto , prospective, diagnostic performance study. Included: anyone, symptomatic and symptomatic, between 3 - 81 years from local primary schools and health canters between 05/2023 and 07/2023. Excluded: patients with severe malaria. Diagnosis: Bioline™ Malaria Ag Pf/Pan and Bioline™ Malaria Ag Pf/Pv RDTs and PCR. Results: The kappa species index was computed using 442 PCR-confirmed positive samples. The sensitivity for P. falciparum detection was 98% (95% CI: 96-99) with Pf/Pan RDTs, yielding a kappa species index of 0.9. Similarly, the sensitivity for P. falciparum detection was 97% (95% CI: 95-99) with Pf/Pv RDTs, accompanied by a kappa species index of 0.9. Pf/PvRDTs demonstrated a sensitivity of 100% (95% CI: 99-100) for P. vivaxdetection, with a kappa species index of 1, indicating strong agreement. Pf/Pan RDTs identified a proportion of 36% of mixed infections. Conclusions: Our findings emphasize the need for careful consideration of the appropriate use of RDTs based on local epidemiology and clinical context. both Ag Pf/Pan and Bioline™ Malaria Ag Pf/Pv RDTs could be used at the peripheral levels where Microscopy and PCR are not possible (CSB1 and CSB 2) and using them according to their availability. At the district level, we could initiate an assessment of geographical cartography which will guide the policy of the use of Ag Pf/Pan and Bioline™ Malaria Ag Pf/PvRDTs according to Plasmodium species identified in different districts. Trial registration: This study is part of the monitoring of quality control of Rapid Diagnostic Test at the National Malaria control Program (NMCP). The clear consent from participating was systematically collected.