WHO PQT in collaboration with PATH and FIND will perform an independent performance evaluation to generate additional performance data for RDTs that are undergoing EUL assessment and for those that are already listed. The evaluation will use a SARS-CoV-2 antigen benchmarking panel developed by PATH and testing will be carried out by one of two independent laboratories familiar with RDT evaluation, using a standardized protocol.
The evaluation will include a verification of analytical performance (analytical specificity, analytical sensitivity including the detection of variants, high dose hook effect), which will provide comparable datasets using a common specimen panel. A summary of the results of the evaluation will be published on the WHO EUL webpage and/or included in the WHO Public Report of the listed product. Aggregated data for comparison across tests will be published on the PATH website.
Testing is planned to commence in the first quarter of 2023 and WHO PQT will notify all eligible manufacturers by email. Manufacturers are required to provide the requisite quantities/lots of the product for this performance evaluation at no charge to the designated laboratory upon request.
Funding support for this evaluation has been provided by FIND.