Malaria Clinical Trial
Official title:
Clinical Performance Evaluation of Malaria Pf Plus RDT and Malaria Pf/Pv Plus RDT for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria
Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have dramatically
improved our ability to control malaria, but proved insufficient to support elimination
efforts because of their limited sensitivity, especially for P. vivax. In addition, the
spread of P. falciparum parasites lacking hrp2 gene jeopardizes the long-term use of P.
falciparum-specific HRP2-based RDTs. An existing partnership between Standard Diagnostics
(SD), FIND, PATH, and Bill and Melinda Gates Foundation (BMGF) is addressing these
limitations by developing two novel malaria RDTs with an analytical sensitivity ten times
higher than the currently available malaria RDTs: a P. falciparum-specific test targeting
both the HRP2 and PfLDH antigens (Pf Plus), and a P. falciparum/P. vivax combo test
additionally targeting the PvLDH antigen (Pf/Pv Plus).
These new combo tests with improved sensitivity may become promising diagnostic tools for the
detection of malaria, especially in settings where current tests prove to be insufficient due
to hrp2 deletion or high burden of P. vivax malaria.
In this study, the investigators will perform a prospective evaluation of Pf Plus and Pf/Pv
Plus tests in malaria-endemic countries to assess their clinical performance for detection of
malaria in their intended-use settings.
n/a
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