How science supported EU policy making in ensuring safe and reliable COVID-19 antigen testing : lessons learnt and recommendations in case of future serious crossborder health threats

In response to the challenges posed by the COVID-19 pandemic and the needs of EU Member States and policy makers related to antigen testing, DG SANTE and the JRC set up a structured targeted approach, which also facilitated the implementation of the EU Digital COVID Certificate (EUDCC). The EU Health Security Committee established in May 2021 a technical working group (TWG) on COVID-19 diagnostic tests. The TWG, consisting of technical experts from 27 EU Member States and Norway, as well as DG SANTE, JRC and ECDC, reviewed proposals put forward by manufacturers for devices to be included in the EU common list of COVID-19 antigen tests. The COVID-19 In Vitro Diagnostic Devices and Test Methods Database, a broadly publicly accessible repository of information on the performance of testing devices and methods for the detection of COVID-19, was created and used by the manufacturers to provide the TWG with the data necessary for their assessment of the proposals against a set of agreed criteria. Devices meeting the criteria were included in the EU common list of COVID-19 antigen tests, upon agreement by the EU Health Security Committee. An automated extraction of data from the JRC database was the basis for the retrieval of information used for the issuing of EUDCC certificates based on COVID-19 antigen testing. This report presents the scientific process put in place to support policy making in the EU's response to the COVID-19 pandemic as regards antigen testing. It highlights critical steps, lessons learnt and concrete recommendations, which may be crucial for the implementation of similar systems in the unfortunate event of a future outbreak of a serious cross-border health threat.