On 30 January 2020, the Director-General declared that the outbreak of COVID-19 caused by SARS-CoV2 constitutes a Public Health Emergency of International Concern (PHEIC) and on 11 March 2020 it was characterized as a pandemic. In vitro diagnostics (IVDs) of assured quality, safety and performance are a critical component of an overall strategy to control the pandemic.

COVID-19 no longer constitutes a public health emergency of international concern (PHEIC) therefore, WHO is no longer accepting any new applications (or resubmissions) under the EUL procedure.

Please refer to the below Q&A for more information.  These questions and answers are intended to provide clarity on the transition plan and the way forward to manufacturers and procurement stakeholders.

• Transitioning Emergency Use Listing for in vitro diagnostics to prequalification assessment - Questions and Answers - Version 2 (Updated 10 July 2023)

Independent evaluation

As of the first quarter of 2023, all SARS-CoV-2 antigen RDTs (listed products and products in assessment) will undergo an independent evaluation of analytical performance. The evaluation will use a SARS-CoV-2 antigen panel developed by PATH and testing will be carried out by independent laboratories, using a standardized protocol to assess analytical performance (analytical specificity, analytical sensitivity including the detection of variants, high dose hook effect). 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.

This project was conceptualized, designed, and implemented by PATH with funding from FIND, and a key partnership with the WHO PQT-IVD.

For further information on the project, including the composition of the benchmarking panel and its use, please refer to link here.