Testing is fundamental to face the COVID-19 pandemic. In particular, antigen tests are widely used in the European Union, both among professionals and the general public. Antigen tests are IVDs (In Vitro Diagnostic medical devices) of class D under the IVDR. This means that they will fall under the highest-risk category of IVDs, needing a Notified Body involvement.
The list of recommended tests
When the Belgian Federal Agency for Medicines and Health Products (FAMHP) published the list of recommended antigen tests for professional use, there were very few independent validation studies. The majority of them were performed by the manufacturers themselves. The initial list includes antigen tests with a sensitivity of ≥ 90% and a specificity ≥ 99%. As more independent studies are currently available, at the beginning of April 2022, the FAMHP replaced the list of recommended tests with the common European list.
The requirements of the common EU list
As of today, the common European list of the Health Security Committee (HSC) includes more than 170 tests. The selection criteria are:
· sensitivity ≥ 80% (or ≥ 90% for samples with a Ct-value ≤ 25);
· specificity ≥ 98%;
· a European independent study using a minimum of 100 RT-PCR positive and 300 RT-PCR negative samples has to confirm the values;
· a technical working group of the HSC has to verify the validation data.
Additionally, the common European list will have two categories as of June 2022: antigen tests evaluated through prospective studies (category A) and antigen tests evaluated through retrospective studies (category B). Both categories meet the requirements to issue EU Digital COVID test and recovery certificates. However, the EU encourages Member States to use those of category A.
Timeline and transition period
The replacement of the FAMHP list with the common European list of the HSC implies that manufacturers cannot apply anymore for the FAMHP list from April 1, 2022. Instead, they have to apply for the HSC list. There is going to be a transition period until July 1, 2022. Until that date, both the HSC list and the FAMHP list will remain in use. Afterwards, professionals can only use antigen tests from the HSC list.
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Expert Consultant, Publications Department
FAMHP. (2022). Replacement of the FAMHP list of recommended SARS-CoV-2 antigen tests for professional use by the common list from the Health Security Committee (HSC). Retrieved on 14/04/2022 from: https://www.famhp.be/en/human_use/health_products/medical_devices_accessories/covid_19/tests/Replacement%20of%20the%20FAMHP%20list