Project Title

Phase 3 evaluation of an innovative simple molecular test for the diagnostic of malaria in different endemic and health settings in sub-Saharan Africa

(Acronyme : DIAGMAL)

François KIEMDE, MSc, PhD

This is a Phase 3 diagnostic evaluation, aimed to evaluate the performance of the mini-dbPCR-NALFIA test for malaria compared to the available diagnostic practice in place at the selecting settings (microscopy and/or RDT) and quantitative PCR as the reference test. Alongside this, we undertake to determine the cost effectiveness of implementing the new diagnostic test in health systems in the participating countries. Furthermore, we will compile a draft registration dossier for the diagnostic platform and explore a potential route to market.

Five African countries will participate in this clinical trial: Burkina Faso, Ethiopia, Kenya, Namibia and Sudan.

December 2019