Results for malaria RDT lot testing
The demand for testing malaria RDT lots has been increasing since its start in 2007 (see graph). The apparent decrease in 2014 was due to an increase in lot sizes and actually corresponds to an increase in demand when considering the number of individual RDTs. Lot testing has been mandatory for all recipients of grants from the Global Fund since 2011 and has been adopted by all major procurers since then.
The primary requesters of malaria RDT lot testing are manufacturers, NGOs, international organizations,, and procurement agencies. According to data collected from lot testing requesters, the RDT lots submitted in 2014 represented about 210 million RDTs for 48 countries, of which 88% were distributed in sub-Saharan Africa.
Results provided to lot testing requesters support decisions for accepting or rejecting RDT lots, provide information on the long-term stability of products and provide comments on observations made during interpretations of results, such as a red background, test line intensity, invalid results and other anomalies. Buffer evaporation has been observed in some RDT single kits, which led to the publication of a notice of concern by the WHO Prequalification of Diagnostics department.
Since the start of the programme in 2007, there has been a clear increase in the quality of tests being procured. Among malaria RDTs submitted to lot testing, 99.5% met WHO procurement and quality standards in 2014 compared to 71.2% in 2007.