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)

Replacement of the FAMHP list of recommended SARS-CoV-2 antigen tests for professional use by the common list from the Health Security Committee
 

The FAMHP replaced its list of recommended SARS-CoV-2 antigen tests for professional use, as published on the FAMHP website, by the common European list of the Health Security Committee (HSC).

The FAMHP list included antigen tests with a sensitivity ≥ 90% and a specificity ≥ 99%. When this list was initially made, very few independent validation studies were available for antigen tests. Hence, the displayed sensitivity and specificity values were based on data from studies performed by the manufacturers themselves.

Later, the common European list of the HSC was published. At this moment, this list contains more than 170 tests. The selection criteria are the following: sensitivity ≥ 80% (or ≥ 90% for samples with a Ct-value ≤ 25) and specificity ≥ 98%. These values need to be confirmed by a European, independent (by preference prospective) study using a minimum of 100 RT-PCR positive and 300 RT-PCR negative samples. The validation data are subsequently verified by a technical working group of the HSC. The list is updated regularly. Only results from tests that appear on this list can be used for a EU Digital COVID Certificate.

Please note that as of 1 June 2022, the common European list of the HSC has been split up in two categories:

  • A-category: consisting of rapid antigen tests for which their performance has been evaluated through prospective studies;
  • B-category: consisting of rapid antigen tests for which their performance has been evaluated through retrospective studies.

While all rapid antigen tests included in the A- and B-category lists are eligible for issuing EU Digital COVID test and recovery certificates, Member States are strongly encouraged to use those devices listed under the A-category. Manufacturers will be able to continue submitting data and information on new evaluation studies, which may change the categorization of their test in the EU common list.

The original FAMHP list has been replaced by the HSC list. This means that from 01/04/2022 onwards, no new applications will be accepted for the FAMPH list. Instead, manufacturers must apply for registration in the list from the HSC. You can find the application procedure for the HSC list here. This procedure is independent of the FAMHP.

A transition period was foreseen until 01/07/2022, meaning that both lists coexisted during this period. 

We would like to remind you that in accordance with Article 5 of the law of 22 December 2020, only tests from the FAMHP list can be used by healthcare professionals. From 01/07/2022 onwards, only tests from the HSC list can be used by healthcare professionals.

Last updated on 14/12/2022