Advances in Rapid Diagnostic Tests for Malaria: A Landscape Review and Analysis.

Each year, Plasmodium-infected mosquitoes cause approximately 250 million cases of malaria within 85 countries containing half of the world's population. Rapid diagnostic tests (RDTs) for blood-based biomarkers of the parasite can accelerate and expand access to diagnostic testing. Malaria RDTs have been endorsed by the WHO for first-line malaria testing, and next-generation assays are being developed to detect multiple Plasmodium antigens. If drug resistance continues to expand, then future RDTs to detect drug resistance will be beneficial. Because malaria RDTs will be an essential diagnostic tool for malaria elimination, particularly in high-burden malaria-endemic countries, we conducted a landscape review and analysis by gathering current information on the advancements in malaria RDTs that are either commercially available or in late-stage development. Overall, we identified 67 malaria RDTs from 27 different international manufacturers. Among these RDTs, most are simple to use on a whole blood specimen, provide test results within 30 minutes, and have reported high (≥98%) diagnostic sensitivity and specificity. Although many malaria RDTs have received WHO approval, clinical and implementation science studies will be needed to determine optimal and efficient delivery and care strategies for malaria RDTs in malaria-endemic settings.