The European Commission’s Health Safety Committee has established a list of COVID 19 rapid antigen tests as well as a standardized data set to be included in COVID-19 test result certificates.
EU Member States have unanimously agreed on a Council Recommendation establishing a common framework for the use of rapid antigen testing and mutual recognition of COVID-19 test results across the EU, as follows:
1. The common list of rapid COVID 19 antigen tests, which are considered suitable for use and are in accordance with testing strategies, must meet the criteria agreed at EU level – Annex I;
2. A common set of standardized data to be included in COVID-19 test certificates, further facilitating the mutual recognition of COVID-19 test results – Annex II
3. Joint list of COVID-19 laboratory antigen tests – Annex III – adopted on 20 October 2021
The first update of the Joint List of COVID 19 Rapid Antigen Tests was approved by the Health Security Committee on 10 May 2021, a second update on 16 June 2021, a third update on 7 July 2021, a fourth update on 14 July 2021, a fifth update on July 23, 2021, a sixth update on October 20, 2021, a seventh update on November 10, 2021, and a new update on December 8, 2021.
Rapid antigen tests, which are based exclusively on sampling materials other than nasal, oropharyngeal and / or nasopharyngeal samples (eg saliva, sputum, blood and / or faeces), are not included in the EU Common List of Antigenic Tests.
There are currently 173 rapid antigen tests on the common list that currently meet the criteria proposed by the EU, but there are also tests that have been removed from the list such as:
NOVA Test ® SARS-CoV-2 Rapid Antigen Test Kit (Colloidal Gold Immunochromatography Manufacturer: Atlas Link Technology Co. Ltd., removed from the list on December 10, 2021 with the grace period until February 2, 2022;
Wantai SARS-CoV-2 Ag Rapid Test (FIA). Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd; removed from the list on October 20, 2021 with the grace period until December 15, 2021;
DIAQUICK COVID -19 Ag Cassette. Manufacturer DIALAB GmbH; removed from the list on December 8, 2021 with the grace period until February 2, 2022.
Genbody COVID-19 Ag Test. Manufacturer: GenBody Inc. removed from the list on October 20, 2021 with the grace period until December 15, 2021;
VivaDiag Pro SARS-CoV-2 Ag Rapid Test. Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd .. Removed from the list on November 10, 2021 with the grace period until January 5, 2022.
Only test results based on nasal, oropharyngeal and / or nasopharyngeal specimens should be valid for the issuance of test certificates for the EU COVID digital certificate.
Based on the definitions and interim criteria agreed by the experts on 29 June 2021, the Technical Working Group agreed on 21 September 2021 on additional definitions, scope, considerations and criteria to be applied to independent validation studies evaluating rapid antigen clinical performance. tests for the diagnosis of COVID-19. These additional definitions, scope, considerations and criteria are used by the Technical Working Group in addition to those set out in Council Recommendation 2021/24/01 when evaluating proposals for new rapid antigen tests to be included in the list. common position of the EU. These were applied to all proposals received after 12 July 2021. For rapid antigen tests that were included in the EU Common List of Rapid Antigen Tests before that date, the criteria will apply from May 2022.
EU-wide criteria for the common list of rapid antigen tests:
are used in practice in at least one EU Member State and have been validated by at least one EU Member State;
Rapid antigen tests using a mixture of different sample materials (nasal, oropharyngeal and / or nasopharyngeal swabs as well as other types of specimens such as saliva) could be included in the EU Common List. However, validation studies of these tests should present the results and information for each type of specimen. Only validation results based on nasal, oropharyngeal and / or nasopharyngeal swabs of such devices will be reviewed by the Technical Working Group and evaluated on the basis of the specified criteria.
Only test results based on nasal, oropharyngeal and / or nasopharyngeal specimens should be valid for the issuance of test certificates for the EU Digital Certificate on COVID.
The EU’s common list of antigen tests does not include rapid antigen self-tests. This includes only those rapid antigenic tests performed by trained medical personnel or trained operators where appropriate (in accordance with Commission Recommendation (EU) 2020/1743 of 18 November 2020).
The EU common list of antigen tests does not include combined rapid antigen tests, which consist of mixing multiple samples into a combined batch or sample for testing.
Only rapid antigen tests bearing the CE marking are included in the EU common list of antigen tests.
“We are going through a difficult period and we have to be careful where and what we buy when it comes to COVID-19 tests. . By improper use of these devices, we risk endangering our own health and the health of those around us. Together we take an attitude – an attitude ”, Sorin Mierlea – President of InfoCons