Results for malaria RDT lot testing
The malaria RDT lot testing programme has experienced a steady increase in workload since it was first implemented in 2007. In 2011, the Global Fund’s Diagnostics Quality Assurance Policy recommended malaria RDT lot testing to all of its grant recipients. As a result, demand has been increasing rapidly. The primary requestors of lot testing are RDT manufacturers, NGOs/IOs, and procurement agencies.
In 2013, 1083 lots were tested, which is a twofold increase from the previous year. 99% of the RDTs submitted for lot testing had a PDS*>75%, as opposed to only 70% in 2007. This means that major procurers are now submitting “good quality RDTs” (according to the Product Testing results) for lot testing before dissemination to the field. RDT lots that were submitted to lot testing in 2013 were disseminated to more than 50 countries (according to information provided by requesters).
In 2014, the trend is decreasing slightly for the first time in seven years. Assuming that last year we reached the highest level of rdt lots tested, we conclude that we may have reached a plateau. The end of the year results will either nullify or confirm this assumption.
*PDS: Panel Detection Score according to WHO performance criteria
Important note: The WHO-FIND lot testing programme currently tests only a proportion of RDT lots procured in the public sector. The RDTs submitted for evaluation are commonly from agencies with strict procurement criteria, so the ‘pass’ rate of these RDTs may not reflect the quality of all RDTs used globally. Similarly, when viewing a failure rate, it is important to consider the number of lots of this product that have been tested.
Lot testing is designed to prevent very poorly performing lots from reaching the field. The sample size is insufficient to make fine distinctions in RDT performance: this is the role of the RDT Product Testing Programme.