A review by the Paul Ehrlich Institute (PEI) has shown that every fifth rapid corona test on the market is useless. But there was no reaction from the authorities – and the tests are still available.
Langen – The omicron wave is rolling and the corona virus is spreading more and more in Germany. Regular quick tests are an integral part of everyday life. The goal: to identify infections early and break the chain of infection. Precisely because rapid tests play such a central role in fighting and containing the pandemic, a lot depends on their reliability. The renowned Paul Ehrlich Institute (PEI), in cooperation with scientists from the Robert Koch Institute (RKI), the Berlin Charité and independent laboratories, has now put 245 antigen rapid and self-tests to the test – with shocking results.
Corona quick tests: Every fifth test on the market is useless
As bild.de reported, 46 of the 245 tests reviewed failed. In order to provide reliable results and to be able to detect an infection with the highest viral load, a rapid test should normally have a sensitivity of at least 75 percent. In eleven rapid tests, this value was zero. According to the Federal Institute for Drugs and Medical Devices (BfArM). bild.de has already responded and removed the affected tests from its list of eligible tests.
Paul-Ehrlich-Institut is not responsible for the banning of rapid antigen tests from the market
What is explosive, however, is that the useless tests remain in circulation because neither the PEI nor the BfArM are officially responsible for taking the tests off the market. That’s loud bild.de is the responsibility of the market surveillance authorities of the federal states and ultimately takes place on the basis of individual case decisions. The best example from the past: The FFP2 mask scandal, when defective masks that provided insufficient protection were in circulation several times last year. The market supervisory authorities intervened quickly and vehemently and banned many masks from the market. In the case of the rapid tests, however, this has not happened so far.
These tests identify the Omikron variant particularly reliably
CE marking of the tests: Manufacturers give their products the mark themselves
But how is it possible for a test that is not even able to detect a corona infection to receive market approval? This is quickly explained: the so-called CE marking is decisive. Depending on the risk assessment of a product, every company can give itself this seal and print it on the packaging of the product offered. The manufacturer thus declares the marketability of his product according to European and international guidelines. There is no independent test center that confirms the actual suitability of the respective products. In this specific case, this means that the useless tests may mean that many corona infections were not detected or were detected too late because the tests were not able to record the viral load at all.
The regulation will only change from May 26, 2022. Then the rapid corona tests will be classified in the highest risk class and an independent review must be carried out by an additional body before a product can be launched on the market.