Coronavirus disease (COVID-19) Pandemic — Emergency Use Listing Procedure (EUL) for IVDs
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.
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.