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EC-antigens-tests

The European Commission stresses the safety provided by medical laboratories accreditation in conducting rapid SARS-CoV-2 antigens tests

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21 April 2021 International

On 23 November last year, the (EU) Recommendation 2020/1743 of the Commission (18 November 2020) on the use of rapid antigen tests for the diagnosis of SARS-CoV-2 infection was published.

The Recommendation sets out guidance for Member States for the use of rapid antigen tests to detect SARS-CoV-2 infection and defines "environments in which implementing antigen tests is appropriate, in order to contain the spread of the coronavirus, and which detect SARS-CoV-2 infections and limit isolation and quarantine measures". In turn, the Recommendation also helps to ensure people’s free movement and the internal market to work properly, at a time when there are limited diagnostic capacities. In particular, it lays down criteria to be used for, among other things, validation and mutual recognition of tests and their results.

As far as laboratories are concerned, the Commission, when talking about 'Diagnostic capabilities and resources', emphasizes the importance of medical laboratories, highlighting in particular those that are accredited and that 'form part of the network of EU laboratories accredited by national bodies of the Member States (ENAC in Spain) in accordance with the harmonized EN ISO 15189 standard'. It concludes by stating that "Accreditation also ensures that these laboratories are regularly monitored and meet the necessary quality and competence requirements."

By recommending the medical laboratories accreditation, the Commission not only seeks to ensure high levels of technical competence in medical laboratories, but also to strengthen the basis for facilitating the mutual recognition of tests in EU countries in line with point 26 and point 18 of the Recommendation: Council Recommendation (EU) 2020/1475 of 13 October 2020 on a coordinated approach to the restriction of free movement in response to the Covid-19 pandemic.


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