The independent laboratory performance evaluation of in vitro diagnostics (IVDs) submitted for prequalification enables WHO to verify the performance characteristics that are considered essential for their use in resource-limited settings. In order to further streamline the prequalification assessment, WHO has developed an alternative performance evaluation mechanism providing the manufacturers with two options to fulfil the performance evaluation requirement of the prequalification assessment.
A first meeting of WHO Prequalification Evaluating Laboratories was organized in June 2018. During this meeting, a number of challenges faced by PELs in the organization of performance evaluations and possible solutions were discussed, which led to a list of action points . The aim of this second meeting of PELs is to follow up on these action points, continue the discussion on challenges faced by PELs and review revised protocols for performance evaluations of serology/antigen and molecular assays.
the Objective of the meeting:
1.To discuss WHO Performance evaluation processes and labs’ experience with the alternative performance evaluation mechanism, including communication strategies with WHO and manufacturers.
2.To review revised protocols, result templates, report templates and other operating procedures.
3.To discuss about the next steps to allow sample sharing between WHO Prequalification Evaluating Laboratories.
