Malaria Rapid Diagnostic Test Performance: Results of WHO Product Testing of RDT's

The largest-ever independent, laboratory-based evaluation of rapid diagnostic tests (RDTs) for malaria has shown that some tests on the market perform exceptionally well in tropical temperatures and can detect even low parasite densities in blood samples, while other tests were only able to detect the parasite at high parasite densities.

This document reports on evaluations co-sponsored by the WHO Regional Office for the Western Pacific (WPRO), WHO-based Special Programme for Research and Training in Tropical Diseases (TDR) and the Foundation for Innovative New Diagnostics (FIND). Testing was performed at the US Centers for Disease Control and Prevention (CDC). Forty-one commercially available RDTs went through a blinded laboratory evaluation.

The findings will serve as a tool for countries to make informed choices, from among the dozens of tests commercially available, on the purchase and use of rapid diagnostics that are best suited to local conditions.

This performance evaluation will also inform procurement and prioritization for diagnostic test entry into WHO Prequalification Diagnostics Programme and WHO Procurement Schemes. Donor agencies also regularly refer to WHO recommendations on diagnostics when making their own purchases.