Sensitive near point-of-care detection of asymptomatic and submicroscopic Plasmodium falciparum infections in African endemic countries.

Abstract

Limited diagnostic capacity for detecting asymptomatic malaria infections with low parasite densities hinders elimination efforts in Africa. Here, we adapt a near point-of-care, LAMP-based diagnostic platform for malaria diagnosis using capillary blood. This Pan/Pf detection method meets the Malaria Eradication Research Agenda (malERA) criteria for community-level screening, with a limit of detection of 0.6 parasites/μL and a sample-to-result time under 45 minutes. We evaluate its performance on 672 capillary blood samples collected at the community level in The Gambia and Burkina Faso, including 146 Plasmodium falciparum positives confirmed by qPCR. The diagnostic platform achieved 95.2% sensitivity (95% CI: 90.4-98.1) and 96.8% specificity (95% CI: 94.9-98.0). It also detected 94.9% (130/137) of asymptomatic infections and 95.3% (41/43) of submicroscopic cases (<16 parasites/μL), outperforming expert microscopy (70.1% and 0%) and rapid diagnostic tests (49.6% and 4.7%). This field-deployable molecular diagnostic method offers a sensitive, scalable solution to support test-and-treat strategies for malaria elimination across Africa.