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Rapid Antigen Tests use across Europe: the EU Commission’s Recommendation

On November 18, 2020, the European Commission (EC) published a Recommendation on the use of rapid antigen tests for the diagnosis of SARS-CoV-2 infection.

This was necessary because the number of SARS-CoV-2 infections continues to rise, and consequently, tests demand increases as well: as a result, Member States’ health systems and medical laboratories are under pressure and testing capacities are often exceeded.

Rapid antigen tests are not the most reliable methodology for COVID-19 diagnostic (they show a lower sensitivity compared to RP-PCR tests), but they can be a useful tool to face the ongoing pandemic because of their short turnaround times and reduced cost. Therefore, the EC’s Recommendation aims to provide Member States with criteria regarding the selection, use and mutual recognition of rapid antigen tests and their results, to ensure the EU functioning in times of limited testing capacities.

Selection Criteria

As for the selection criteria, the EU Commission has elaborated the following advices:

– Member States should use rapid antigen tests with acceptable test performance, which means sensitivity ≥ 80% and specificity ≥ 97%;

– Rapid antigen testing should be conducted by trained personnel (Member States should consider training additional operators);

– Rapid antigen tests should be used when the viral load is highest: within five days after the onset of symptoms, or within seven days after exposure to a confirmed COVID-19 Case. Asymptomatic persons are not the target of these tests;

– Rapid antigen tests should carry the CE mark and they must be validated against RT-PCR test standards, bearing in mind the target population and the intended use. Before affixing the CE marking, manufacturers of rapid test shall draw up a technical file demonstrating that the test is safe and performs as intended by the manufacturer, in accordance with the requirements laid down in Annex I of the Directive. Once the Regulation (IVDR) becomes applicable, these tests will need to be additionally assessed and certified by a Notified Body.

Use Criteria

Rapid antigen tests use should be encouraged when RT-PCR tests availability is limited and in order to depressurize healthcare and social-care systems. In light of this, they should be used for recurring testing of hospital and long-term care facilities’ staff and to allow the admission to healthcare infrastructures.

At the same time, they can be used for targeted population-wide testing approach, for individuals with COVID-19 signs in areas where the positivity rate is very high (≥10%) or for individuals without any symptoms in settings where the positivity rate is expected to be very high (e.g., in case of contact tracing).

Considering the actual reliability of rapid antigen tests, the administration of a confirmatory test (either a RT-PCR or a repeated antigen test) should be considered every time the first result is not in accordance with the expected one (e.g., a negative result within a population with high infection prevalence).

Validation and Mutual Recognition Criteria

Mutual recognition of test results among Member States (Council Recommendation 2020/1475point 18) is crucial in order to ensure the free movement of people and the functioning of the internal market; therefore, results performed with tests that meet the selection criteria of the EC Recommendation, should be recognised by all Member States.

Moreover, States should follow the European Centre for Disease Prevention and Control (ECDC) technical guidance on the use of rapid antigen tests for COVID-19 and work together with the EU Commission to align testing strategies and to share any relevant information or study.

Update On December 18, 2020, the EU Commission adopted a Proposal for a Council Recommendation on a common framework for the use, validation and mutual recognition of COVID-19 rapid antigen tests in the EU, in which the criteria explained above are stated once again, so to adopt a common approach across Europe on this matter.

On the same day the EU Commission signed “a framework contract with Abbott and Roche allowing the purchase of over 20 million rapid antigen tests for up to €100 million, financed by the Emergency Support Instrument (ESI). From early 2021, these tests will be made available to Member States, as part of the EU strategy to COVID-19 testing.” (European Commission, 2020)

Francesca Santacatterina

Regulatory Affairs Department

22/12/2020

If you want to keep updated on the latest existing COVID-19 diagnostic methods, consult the EU Commission’s COVID-19 In Vitro Diagnotic Devices and Test Methods Database.

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