Malaria Rapid Diagnostic Test Performance
Results of WHO product testing of malaria RDTs: Round 1 (2008)
April 2009
ISBN 978 92 4 159807 1
Special Programme for Research and Training in Tropical Diseases
This report, which presents the results of the first round of WHO product testing of malaria antigen-detecting RDTs, was completed in November 2008 in collaboration with FIND, the U.S. Centers for Disease Control and Prevention (CDC) and other partners.
All companies manufacturing under ISO-13485 Quality System Standard were invited to submit up to 3 tests for evaluation. In this first round of testing, 41 products from 21 manufacturers were evaluated against prepared blood panels of cultured Plasmodium falciparum parasites and patient-derived P. falciparum and P. vivax parasites, and a parasite-negative panel. Thermal stability was assessed after 2 months of storage at elevated temperature and humidity, and a descriptive ease of use assessment was recorded.