SARS-CoV-2 Test Systems
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and the Paul-Ehrlich-Institut are the authorities that provide information on SARS-CoV-2 test systems. The information materials complement each other. The legal framework for this, among other things, is the Coronavirus Test Regulation (Coronavirus-Testverordnung, TestV).
The BfArM provides a list of antigen tests for the direct detection of the pathogen Coronavirus SARS-CoV-2. This list contains those tests which, according to the manufacturer, are legally marketed in Europe or Germany (as applicable) pursuant to the conditions laid down in the Medical Devices Act (Medizinproduktegesetz, MPG), and fulfil all the minimum criteria for antigen tests laid down by the Paul-Ehrlich-Institut in consultation with the Robert Koch-Institut (RKI).
The list from the BfArM thus provides an overview of the antigen tests which, according to the specifications from the manufacturers, fulfil the minimum criteria, and which are eligible for refunding pursuant to the CoronavirusTestV.
In addition, the Paul-Ehrlich-Institut performs a comparative evaluation of rapid antigen tests in the laboratory. If a test passes this evaluation, it will be included in the list “Comparative evaluation of the sensitivity of rapid SARS-CoV-2 antigen tests” of the Paul-Ehrlich-Institut. If the test does not fulfil the criteria for the evaluation, it will be removed from the BfArM list.
The comparative evaluation performed by the Paul-Ehrlich-Institut takes into account a random sample of the tests listed at the BfArM. Thus, the list of evaluated tests is continuously extended.