The European Commission published on Wednesday 18 November a Recommendation on the selection and use of antigen tests to detect the presence of coronavirus, together with technical guidance from the European Centre for Disease Prevention and Control (ECDC).
However, it postponed sine die its Recommendation on quarantines, relying in the meantime on the ECDC opinion (see EUROPE 12589/2).
As a follow-up, the Commission announced that it has signed an agreement with the International Federation of Red Cross and Red Crescent Societies (IFRC) to mobilise 35.5 million euros from the Emergency Support Instrument (ESI) to increase the capacity for Covid-19 testing in the EU.
A cautious approach
The Recommendation complements those made regarding screening strategies, which invited Member States to agree on selection criteria for antigen tests and on a framework for mutual recognition (see EUROPE 12591/1).
It provides guidance, while taking care not to be overly prescriptive, given the divergent views among Member States. According to a document prepared by the rotating Presidency of the Council of the EU, dated 12 November, “a large number of Member States” believe that it is indeed premature to set minimum standards and common criteria in view of the lack of solid scientific data. In this context, the Recommendation invites Member States to finalise their studies and to share the results with the ECDC and the Commission, with a view to aligning them as much as possible with those of other Member States.
In the Commission’s view, such coordination is essential to remove existing obstacles to free movement by allowing the results of a test carried out in one Member State to be recognised in another Member State.
Common criteria
In concrete terms, the Recommendation stresses that the more accurate PCR tests are obviously the “gold standard”. However, compared to PCRs, antigen tests require simple equipment and fewer highly qualified personnel. They are also cheaper and faster.
In this context, the European Commission recommends the use of antigen tests in situations where PCR tests are lacking (or take more than 24 hours) and in areas where the number of infections is above 10% “within five days after the onset of symptoms or seven days after exposure to a confirmed case”. Antigen tests can also be used to regularly check health care staff.
For the devices to be used, the Recommendation recalls the existing legislative framework, namely the Directive on in vitro medical devices (98/79/EC), which will be replaced in 2022. It calls on Member States to only use tests that have received the “CE” marking in accordance with this Directive and to select the most effective tests, which have a minimum of 80% sensitivity and 97% specificity, as recommended by the World Health Organization (WHO).
At the time we went to press, the ECDC technical criteria had not yet been published.
Link to the recommendation: https://bit.ly/35H9dqc (Original version in French by Sophie Petitjean)