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On this page, the BfArM provides information on the following rapid antigen tests (so-called Point of Care Tests (PoC)) for direct pathogen detection of the coronavirus SARS-CoV-2:

  • Antigen tests for professional application, the Subject of the claim according to § 1 sentence 1 Coronavirus Test Ordinance (TestV) are ("rapid tests") and
  • Antigen tests for Own application (“Self-tests”) whose placing on the market without CE marking is currently authorized for a limited period by the BfArM in accordance with Section 11 (1) MPG (special authorization by the BfArM).

In the following you will find further information on the corresponding tests as well as a link to the respective list of the BfArM.

Antigen tests for SARS-CoV-2 for professional application, the Subject of the claim according to § 1 sentence 1 Coronavirus Test Ordinance (TestV) are ("rapid tests")

The BfArM provides a list of the antigen tests for the direct detection of pathogens of the coronavirus SARS-CoV-2, which are the subject of the claim according to § 1 sentence 1 of the "Ordinance on the right to testing in relation to a direct pathogen detection of the coronavirus SARS-CoV-2 (Coronavirus Test Ordinance - TestV) "are.

The list is continuously updated and contains the corresponding tests that, according to the current knowledge of the BfArM, are on the market in Germany and, according to the manufacturer's information, the current ones carried out by the Paul Ehrlich Institute (PEI) in coordination with the Robert Koch Institute (RKI ) meet the specified minimum criteria for antigen tests.

In this context, we would like to point out the minimum criteria for antigen tests.

It should be noted that this list only includes antigen tests that have been reported to the BfArM by the respective manufacturer or distributor with a view to inclusion in the list. Since the BfArM is not involved in questions of market access and the conformity assessment of medical devices (see below for the exception for temporary special approvals for Germany), the list does not provide a comprehensive overview of all the corresponding antigen tests available on the market in Europe and thus also in Germany. The BfArM only compares the manufacturer's information with the minimum criteria set by the PEI in coordination with the RKI.

List of antigen tests for direct pathogen detection of the coronavirus SARS-CoV-2, which are the subject of the claim according to § 1 sentence 1 of the "Ordinance on the right to testing in relation to a direct pathogen detection of the coronavirus SARS-CoV-2 (Coronavirus Test Ordinance - TestV) "are.

Antigen tests for Own application ("Self-tests") whose placing on the market without CE marking is currently temporarily approved by the BfArM in accordance with Section 11 (1) MPG (special approval by the BfArM)

The BfArM provides a list of the antigen tests for the direct detection of pathogens of the coronavirus SARS-CoV-2, which are intended by the manufacturer for self-use ("self-tests") and which are currently being marketed by the BfArM without CE marking in accordance with Section 11 (1) MPG is approved for a limited period (special approval by the BfArM).

The list is continuously updated as soon as the BfArM has issued further corresponding special approvals or these no longer exist, e.g. due to the expiry of the time limit or completion of the regular conformity assessment and CE marking.

The basis for the assessment of the BfArM are the procedures and criteria mentioned further down on this page under the menu item “Notes on the special approval of antigen tests by the BfArM”. In the case of a special approval of antigen tests for self-use, the BfArM assesses not only the clinical quality of evidence (including a positive evaluation by the Paul Ehrlich Institute) but also the usability of the sampling and test handling, including the instructions for use specifically geared towards lay use.

List of antigen tests for in-house use ("self-tests") whose placing on the market without CE marking is currently temporarily approved by the BfArM in accordance with Section 11 (1) MPG (special approval by the BfArM)

Minimum criteria for antigen tests defined by the Paul Ehrlich Institute (PEI) in coordination with the Robert Koch Institute (RKI)

In coordination with the RKI, the PEI has defined the minimum criteria for antigen tests for the direct detection of pathogens of the coronavirus SARS-CoV-2, which the BfArM applies with regard to a possible inclusion of corresponding tests in the list according to § 1 sentence 1 of the Coronavirus Test Ordinance - TestV .

A listing by the BfArM within the meaning of Section 1 Paragraph 1 Clause 1 TestV is therefore only possible if, according to the manufacturer, according to the specifications of the Medical Devices Act (MPG), corresponding tests are lawfully on the market in Europe or Germany and all by Paul-Ehrlich -Institut (PEI) in coordination with the Robert Koch Institute (RKI), the following minimum criteria for antigen tests are met:

Current minimum criteria of the PEI in coordination with the RKI for SARS-CoV-2 antigen tests within the meaning of Section 1 (1) sentence 1 TestVO (as of January 15, 2021)

Further information on the minimum criteria for antigen tests established by the PEI in coordination with the RKI can also be found under the following link.

Notes on the special approval of antigen tests by the BfArM

The BfArM has the option of allowing medical products that have not undergone a regular conformity assessment procedure for CE marking to be placed on the market for a limited period in Germany if this is in the interests of health protection. This can be the case if there is no alternative requirement situation, i.e. the corresponding urgent medical need is not covered otherwise and insofar, from the point of view of health protection, the conclusion of a regular conformity assessment procedure for the medical device cannot be waited for.

Notes on the special approval of antigen tests by the BfArM

Unlawful use of the BfArM logo for advertising purposes

Given the occasion, we would like to point out that the use of the BfArM logo, the official lettering "Federal Institute for Drugs and Medical Devices", the federal official flag, the federal eagle, the federal coat of arms or other state symbols in connection with advertising statements is not permitted and only federal authorities is reserved.

The unauthorized use of the federal eagle, the federal coat of arms, the official flag of the federal government or, in this regard, images that are likely to be confused, constitutes an administrative offense according to Section 124 of the Administrative Offenses Act (OWiG), which as such can be prosecuted and punished with a fine.

Note from the RKI: What should be considered for antigen tests for self-use (self-tests) for the detection of SARS-CoV-2?

In connection with the use of antigen tests for self-application (self-tests) to detect SARS-CoV-2, we would like to refer to the relevant recommendations of the Robert Koch Institute (RKI).

What should you watch out for in antigen tests for self-use (self-tests) to detect SARS-CoV-2?