On February 2nd, 2021 the Third Regulation to amend the delivery regulation for medical products (MPAV) became effective. In this regulation, in-vitro diagnostics were exempt from the limitation to the medical profession and thus qualified for the use by non-medical personnel.
End of February, The federal institute for pharmaceutical products (BfArM) has issued the first special permits, including the Technomed rapid antigen test manufactured by Xiamen Boson Biotech Co., Ltd. According to §11 paragraph 1 medical products law (MPG), rapid antigen tests with this special permit can be used by the layperson to detect an infection with SARS-CoV-2. Further special permits will follow in the next days.
The majority of rapid antigen tests, however, must be conducted by medical professionals – and industrial safety measures must be adhered with.
Especially a correct execution of the swabbing phase, when the infected tissue is taken with the swab from the throat or nose. In case the swabbing sample is not gathered in the correct way, the test result can be false.