Following up on the Council conclusions of 11 December, the Commission has today adopted a proposal for a Council recommendation on a common framework for the use, validation and mutual recognition of rapid antigen tests. Since the outbreak of the COVID-19 pandemic, diagnostic testing has been rapidly evolving, demonstrating its central role in outbreak control. The recommendations put forward by the Commission will ensure the uniform use, validation and recognition of rapid antigen tests in the EU.
The Commission has also today 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.
Stella Kyriakides, Commissioner for Health and Food Safety, said: “Rapid antigen tests offer us speed, reliability and quick responses to isolate COVID cases. This is crucial to slow down the spread of the pandemic. 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. To help in these efforts, we have today signed a contract to support Member States with over 20 million rapid tests.”
Currently, the most reliable methodology for COVID-19 testing is the RT-PCR test. However, due to their increased use, resulting in shortages, and to their relatively high cost and long time required to produce a test result, the complementary use of rapid antigen tests in specific settings is increasingly advisable.
Concerning the use of rapid antigen tests, Member States are recommended to:
- Use rapid antigen tests to further strengthen countries’ overall testing capacity, particularly as testing remains a key pillar in controlling and mitigating the ongoing COVID-19 pandemic;
- Ensure that rapid antigen testing is conducted by trained healthcare personnel or other trained operators where appropriate, and in line with national specifications, and in strict accordance with manufacturer’s instructions and subject to quality control.
- Invest in training and, if appropriate, certification of healthcare personnel and other operators to carry out sampling and testing, thereby ensuring adequate capacities as well as safeguarding the collection of good quality samples.
- Consider in particular the use of rapid antigen tests in the following situations and settings: COVID-19 diagnosis among symptomatic cases, contacts of confirmed cases, outbreak clusters, screening in high-risk areas and closed settings.
- Use rapid antigen tests for population-wide screening in epidemiological situations or areas where the proportion of test positivity is high or very high;
- Ensure that strategies are put in place that clarify when confirmatory testing by RT-PCR or a second rapid antigen test is required,
- Continue to monitor and asses testing needs in line with epidemiological developments.
Concerning the validation and mutual recognition of rapid antigen tests, Member States are recommended to:
- Agree on, maintain and share with the Commission a common list of rapid antigen tests that are in line with countries’ testing strategies and appropriate for the situations described above; that carry CE marking, meet the minimum sensitivity and specificity requirements as defined by the Commission and the ECDC, and that have been validated by at least one Member State;
- Agree that this common list of rapid antigen tests is updated on a regular basis, particularly as new results from independent validation studies will become available and new tests will enter the market;
- Agree to mutually recognise the test results of a selection of tests included in this common list;
- Explore the need and possibility for a digital platform to validate the authenticity of COVID-19 test certificates.
At the European Council at its meeting on 10-11 December, EU leaders adopted conclusions on COVID-19 in which they called on the Commission to present a proposal for a Council Recommendation on a common framework for rapid antigen tests and for the mutual recognition of test results.
Today’s proposal builds on the previous Commission recommendation on the use of rapid antigen tests for the diagnosis of SARS-CoV-2 infection of 18 November. This follows the Commission’s recommendation on 28 October to ensure a common approach and more efficient testing strategies across the EU.
Adopted by the Council in April 2020, the Emergency Support Instrument (ESI) allows the EU budget to step in to provide emergency support to allow the Union as a whole to address the human and economic consequences of a crisis such as the ongoing pandemic.
The Emergency Support Instrument has already been used for the advance purchase of vaccines and PPE masks earlier this year.
Source: Rapid antigen tests (europa.eu)
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