Malaria rapid diagnostic test performance. Results of WHO product testing of malaria RDTs: Round 5 (2013)
This report, published in conjunction with a summary overview of results of rounds 1–5, is the fifth 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. It can be used by malaria control programmes and guide WHO procurement recommendations for these diagnostic tools.
In round 5, 42 products were evaluated, including 19 new products and 23 resubmissions of products assessed in previous rounds. Of these 10 were compulsory resubmissions of products previously assessed but not submitted since Round 1. The overall range of results were similar to those reported in rounds 1–4. The results for most of the compulsorily retested products were within 10% of the initial test.
New in this report is: i) the overview of malaria antigen concentrations in the wild-type P. falciparum and P.vivax evaluation panels used in rounds 1-5; ii) the inclusion of data on observed RDT anomalies, based on a pictorial guide, that can potentially affect test interpretation; and iii) the simplified presentation of results with colour-coding based on the current WHO recommended procurement criteria.
The evaluation programme is funded by WHO and the Foundation for Innovative New Diagnostics (FIND), through a grant from UNITAID. Testing is performed at the Centers for Disease Control and Prevention (CDC) in Atlanta, USA.