COVID antigen testing framework laid out by EC

Regulatory NewsRegulatory News | 21 December 2020 |  By 

The European Commission is purchasing more than 20 million rapid antigen tests for SARS-CoV-2, the virus that causes COVID-19, and making them available to member states. At the same time, EC is also proposing a framework for a common approach for use, validation and mutual recognition of the tests across the European Union’s member states.
Rapid antigen tests are a tool “to further strengthen countries’ overall testing capacity, particularly as testing remains a key pillar in controlling and mitigating the ongoing COVID-19 pandemic,” said the EC in an 18 December press release announcing its antigen test rules and increased test availability.
The additional tests are being acquired from Abbott and Roche through up to €100 million in financing from the Emergency Support Instrument. This instrument was used earlier in the pandemic to purchase masks for use during the pandemic by health care workers; vaccine purchases have also been made with funds from the instrument.
The announcement came just days before the European Union is likely to begin administering vaccinations against COVID-19. Stella Kyriakides, EC commissioner for health and food safety, said that testing will still be necessary during the period when individuals are being vaccinated, and rapid antigen tests afford “speed, reliability, and quick responses to isolate COVID cases.”
Added Kyriakides, “Testing will remain fundamental in the coming months, even as we aim to start rolling out our vaccines in the EU from 27 December. We need to scale up testing capacity in parallel to keep the virus under control.”
Under the proposed common framework for antigen testing, member states are encouraged to use rapid antigen tests to bolster testing capacity. Testing should be conducted by trainer operators and manufacturers’ instructions should be followed strictly. Member states are also advised to invest in training and certification as necessary to achieve enhanced testing.
Rapid antigen tests may be particularly useful for diagnosing COVID-19 in symptomatic individuals and their contacts; these rapid tests may also be useful when outbreak clusters are identified or in areas or among populations assessed as being at higher risk of contracting COVID-19.
Population-wide screening for COVID-19 with rapid antigen tests is appropriate “in epidemiological situations or areas where the proportion of test positivity is high or very high,” according to the EC proposal. In any case, member states should have a plan for confirmatory testing by reverse transcriptase-polymerase chain reaction testing, or an alternate rapid antigen test.
The framework calls for members states to develop a common list of rapid antigen tests. Tests that make the list – which should be shared with EC – should be “in line with countries’ testing strategies” and be appropriate for use in the circumstances described by EC in the framework. Additionally, rapid antigen tests should carry the CE mark and meet minimum requirements for sensivitiy and specificity. They should be validated by “at least one” member state.
Since new tests are entering the market and tests are being newly validated, the list should be updated regularly, said EC. Potentially, a digital platform could be used for validation of COVID-19 test certificates.
Importantly, member states should agree on mutual recognition of results of “a selection of tests included in this common list.”
European Commission


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Tags: coronavirus, EMA, EU

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