Malaria rapid diagnostic test performance. Results of WHO product testing of malaria RDTs: round 7 (2015-2016)
This report, published in conjunction with a summary overview of results of rounds 1–7, is the seventh 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.
These results constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs and form the basis for current WHO procurement recommendations. In round 7, 46 RDTs from 27 manufacturers were assessed. For the first time the evaluation included an assessment of product compliance with best practices for malaria RDT labelling and instructions for use.
The evaluation reported here was a joint project of WHO, the Foundation for Innovative New Diagnostics (FIND) and the United States Centers for Disease Control and Prevention (CDC) within the WHO-FIND Malaria RDT Evaluation Programme. The project was financed by FIND through a grant from UNITAID.
Supplementary document 1 – checklist on labelling and instructions for use
Supplementary document 2 – annex on labelling and instructions for use