Rapid Diagnostic Test for Malaria Antigen

Rapigen has developed a rapid diagnostic test (RDT) for malaria that accurately detects both Plasmodium falciparum and Plasmodium vivax targeting a protein distinct from the Histidine-rich protein 2 (HRP2). This can address the critical of false-negative results associated with HRP2 deletion in existing RDTs. The project includes clinical validations and a usability study, gathering clinical data that meets WHO PQ criteria through collaborative efforts in Ethiopia and Brazil. The ultimate goal is to submit a WHO PQ dossier for RDTs that detect combined antigens of HRP2 and parasite lactate dehydrogenase (pLDH). Achieving WHO PQ would enable distribution of reliable, high-performance RDTs to LMICs at affordable prices, significantly enhancing malaria detection and treatment, leading to improved health outcomes in endemic regions.