NCT03960632

Performance Evaluation of Malaria Plus RDTs

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 6,546 (estimated)
• Sponsor: Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Malaria

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Abbott SD Bioline Malaria Pf Plus (05FK150) and Abbott SD Bioline Malaria Pf/Pv Plus (05FK160))	Qualitative in vitro tests for the detection of Plasmodium antigens

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2019-05-23
• Last updated: 2020-09-16