Malaria rapid diagnostic test performance. Results of WHO product testing of malaria RDTs: Round 4 (2012)
This report is the fourth in a series of laboratory-based evaluations of rapid diagnostic tests (RDTs) for malaria. It provides a comparative measure of their performance in a standardized way to distinguish between well and poorly performing tests. This information can be used by malaria control programmes and to guide UN procurement policy for these diagnostic tools.
In Round 4, 48 products were evaluated, including 13 resubmissions from earlier rounds of product testing. Overall, the majority of resubmitted products either maintained or improved their performance in Round 4, indicating product improvement by the manufacturers. Also included in the report is an algorithm to assist in the RDT selection process, a field tool to assess RDT packaging, safety and ease-of-use, and a pictorial guide to common anomalies seen in production lots.
The evaluation programme is co-sponsored by the Foundation for Innovative New Diagnostics (FIND), the Special Programme for Research and Training in Tropical Diseases (TDR) and WHO/GMP. Testing is performed at the Centers for Disease Control and Prevention (CDC).