Support for the development of the next generation of highly sensitive combo rapid diagnostic tests to detect all malaria species
The overall goal of this project is to enable the establishment of reference material and clinical specimen bank to support the development of the next generation of highly-sensitive combo rapid diagnostic tests to detect all malaria species.
The detection and treatment of symptomatic and asymptomatic infections is considered as one of the key strategies to stop transmission and accelerate malaria elimination. However, an important proportion of the malaria reservoir cannot be detected with current available rapid diagnostic tests (RDTs), therefore more sensitive, easy-to-use and affordable tests are needed.
Having access to standardized reference materials and to a well characterized specimen bank is critical in order to design, develop, and validate test prototypes. The scope of this project is to extend FIND’s previous work on P. falciparum to other Plasmodium species infecting humans with the generation of reference materials to improve pLDH-detecting RDTs. pLDH recombinant proteins will be produced. Samples from patients infected with all Plasmodium species, as well as negative samples, will be collected and characterized to establish a specimen bank for evaluation of next generation RDTs. A P. vivax reference sample will be prepared and evaluated in partner laboratories in order to establish the first WHO endorsed international biological standard for assays detecting pLDH. Furthermore, FIND will support the development of a business case to guide development of non-invasive diagnostic tests for malaria.