Results for malaria RDT lot testing
Since the start of routine lot testing in 2003, the WHO-FIND lot testing programme has experienced a steady increase in workload. The Global Fund’s new diagnostics quality assurance policy now recommends lot testing to all of its grant recipients and as a result, it is expected that demand will increase even further and FIND is preparing to meet this growth. In 2010 alone, 236 lots underwent initial routine testing for a range of procurement agencies and national malaria programmes. This number had risen to 365 lots in 2011, a 50% increase from the previous year, and by 2012, 567 lots were tested, which was a 55% increase from the previous year.
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.