Status: 09.01.2022 10:57 a.m.
Many quick and self-tests are not independently checked or do not do particularly well in checks, warn virologists and consumer advocates. It is difficult for laypeople to see through which tests are suitable.
A common morning at the Bilk test center in Düsseldorf. A queue forms in front of the former pharmacy shortly before 9 a.m., then it starts. Medically disguised with FFP2 masks and visors, the employees routinely take the swabs. Some need the test for work, many are here because they have to show a negative test result for exercising in the gym or gym or want to secure a meeting with family and friends.
There are currently around 700 tests per day, says Aris Kelz. The psychology student comes from a family of pharmacists and opened the test center last year. At the moment, the hit rate is going in the direction of one percent. That is a lot, says Kelz, “when you consider that we are encouraged to do so and knowingly only test asymptomatic patients”.
Great confidence in rapid tests
Most of those who get tested that morning have great faith in the rapid antigen tests. Both for the citizen tests in the test center and for self-tests that can be bought in pharmacies, drugstores, supermarkets or online.
This is probably also due to the fact that the political leaders in Germany rely heavily on the rapid tests – also in view of Omikron. 2G-Plus is the new measure of all things and the earlier free testing from quarantine or domestic isolation should not only be possible with a PCR test, but also with a rapid test. This is what the Chancellor and the federal states have just decided. However, it has not yet been scientifically clarified how well the tests really work with the new variant.
How well do the tests recognize Omikron?
In any case, Oliver Keppler is concerned. Not just because of Omikron – the virologist from the Ludwig Maximilians University in Munich has been warning of the poor quality of many rapid tests for months. “We currently have around 600 different rapid antigen tests on the German market” – many of them have not yet “been tested by independent bodies or scientists”. Basically, there are big qualitative differences, “in this respect the informative value of the self-tests and rapid tests is very limited”.
The tests only offered a false sense of security and led one to no longer behave with sufficient caution. “If a person tests themselves and has a negative result, I think they are right to assume that a test available in Germany also delivers a reasonable result that I can largely rely on. And that is not the case.”
Approval is often based on manufacturer information
The problem: Currently, the test approvals are mainly based on manufacturer information. The European approval procedure is not due to change until May, but questionable tests can potentially remain on the market until 2025 due to a transition period – and they are also up-to-date, such as research by monitor and “Business Insider” have shown.
Arne Weinberg from the consumer advice center in North Rhine-Westphalia calls for a comprehensive, independent evaluation of all available tests. Even with self-tests, users should have clarity. Like virologist Keppler, the health market expert sees a large information and transparency deficit with regard to the quality of the rapid tests that can be sold in Germany.
PEI evaluates rapid tests
The Paul Ehrlich Institute (PEI) is part of the Federal Ministry of Health and tests rapid tests – so far, however, only some of the tests available have been evaluated.
Scientific accuracy comes before speed, emphasizes Klaus Cichutek, President of the PEI in an interview with the ARD capital studio. “One hundred percent security” does not exist with the antigen rapid tests, they are a first indication and are there to prevent “so-called superspreading events”. “That means attacking people who still have a high viral load in the nasopharynx and who are also at high risk of the virus being transmitted in contact with others. That is the function of these tests and not absolute accuracy.” The PEI has currently evaluated 245 tests and classified 46 of them as unsatisfactory.
Unclear standards, difficult to understand
For laypeople with no prior scientific knowledge the corresponding list, which is available as a PDF on the Internet, but difficult to understand, criticizes Weinberg, a consumer advocate. “The test results are not so understandable that the consumer can immediately see what the test that I have in hand is good for.” Some tests are also on the market under a different name and then not on the list.
In addition, it is not understandable why a test does not fail in the PEI evaluation if it works reliably with “very high viral load”, but only works poorly with only “high viral load”: “Tests have passed this check, those with very have a high viral load of around 100 percent, i.e. are very good, but are less than ten percent with a high viral load. ” Such tests should then still be used for citizen tests that the state pays for.
Virologist Keppler is also not satisfied with the PEI evaluation. It is an “important beginning”, but from a scientific point of view “does not correspond to international standards, neither in the implementation nor in the interpretation of the data”. That needs to be improved. In addition, the results must also have consequences – and bad tests actually disappear from the market.
What is the Ministry of Health doing?
PEI boss Cichutek defends the evaluations of his authority that they have “applied high scientific standards” and the criterion that “75 percent of the samples have to be recognized”. “We’re talking about a certain continuum of sensitivity and test sensitivity. But of course there are a number of tests that are better or worse within this continuum.” The user-friendliness of the listing has also been “greatly improved” – for example through alphabetical sorting. “But that could be made even easier for the layman.”
According to Weinberg and Keppler, but also the Federal Ministry of Health would have to provide more effective public awareness of the quality of rapid tests. It is unclear why the ministry does not issue a clear warning about inferior testing. A request from the ARD capital studios the ministry has so far left unanswered.