Following the EU Commission’s proposal of December 18, 2020, the Council of the European Union adopted on January 21, 2021 a Recommendation on a common framework for the use and validation of rapid antigen tests and the mutual recognition of COVID-19 test results in the EU.
The Recommendation is not legally binding, but it provides Member States the best practices they are encouraged to follow.
The document underlines, once again, that testing is a fundamental part of the EU strategy to face the COVID-19 pandemic: in fact, it allows to take targeted actions, such as isolation and quarantine. Therefore, rapid antigen tests should be used in the following situations:
- Symptomatic people;
- Contacts of confirmed cases;
- Outbreak clusters;
- Screening in high-risk areas and closed setting – like hospitals, retirement facilities, schools and prisons.
Moreover, EU Member States shall monitor the development of new rapid tests to detect SARS-CoV-2 infection (as, for example, self-sampling) in order to be able to modify testing strategies.
Concerning validation and mutual recognition of rapid antigen tests, Member States should create a common list, updated on a regularly basis, of tests that meet the following criteria:
- Carry the CE marking;
- Meet minimum performance requirements (sensitivity ≥90% and specificity ≥97%);
- Have been validated by at least one Member State.
Furthermore, EU Countries should agree on a common standardized set of data to be included in the form for test result certificates, in order to facilitate the test results’ mutual recognition among Member States. The creation of a digital platform allowing validation of the standardized COVID-19 test certificates must be discussed by the Council along with the EU Commission.
Lastly, Member States shall keep investing in independent validation studies of rapid antigen tests, in order to evaluate their performances against RT-PCR tests.
Francesca Santacatterina
Regulatory Affairs Department
27/01/2021
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