Many rapid antigen tests are not reliable enough. Next year, they will have to be inspected by independent authorities. So far, manufacturers can certify their tests themselves in accordance with the current EU directive. Currently, independent verification is not required. According to information from the Paul Ehrlich Institute (IPE), this will change as of May 2022: The tests will be examined and independently verified.
The Paul Ehrlich Institute and other institutions examined a total of 122 rapid tests for the Covid 19 antigen.Their sensitivity, i.e. their ability to detect the SARS-CoV-2 virus, was tested. “The result: the quality of the tests varied widely,” IPE reports. Twenty-six tests did not provide the required sensitivity of 75 percent. Nonetheless, the Institute says rapid tests can help stop a pandemic. “With adequate quality, rapid antigen tests allow rapid identification of acutely infected and potentially infectious individuals and allow immediate action to be taken to limit the spread of the virus.”
source: www.ndr.de