Field and laboratory evaluation of Abbott-Bioline™ Malaria Ag Pf/Pv RDT performance in a high-transmission setting: contrasting results with a low-endemic area

Despite using identical lots that showed 18% sensitivity at the Thailand-Myanmar border, Abbott-Bioline™ Malaria Ag Pf/Pv RDTs achieved 99.1% sensitivity in Madagascar. This difference likely reflects higher parasite densities in the Malagasy high-transmission setting (geometric mean 10,006 parasites/µL) compared to low-transmission elimination contexts. Both RDTs met WHO performance thresholds against microscopy but missed approximately 25% of PCR-positive infections. These findings demonstrate that RDT performance is highly context-dependent and underscore the need for enhanced post-deployment surveillance.