E.A way out of the pandemic can only succeed with a well thought-out test strategy. In addition to the classic PCR test, which is evaluated in the laboratory, there are rapid antigen tests. They no longer need a laboratory, but the tests must be carried out by trained personnel. In addition to the rapid antigen tests, there should be self-tests, which the federal and state governments are also hoping for. “As soon as manufacturers of corresponding self-tests, which are intended for use without prior training, apply for approval, the federal government will examine them quickly and, if the test is successful, approve them,” says the draft resolution for the federal and state video conference this Wednesday.
Editor in the features section, responsible for the “Nature and Science” section.
Political correspondent in Berlin, responsible for “Bildungswelten”.
Both rapid tests have in common that a positive result must be confirmed by a PCR test. Even a negative test result is no guarantee that the person is not infected. Too large a number of false-negative test results in the self-test could “have fatal consequences,” it says in the draft resolution.
Can you already buy self-tests in the pharmacy now?
So far this has only been possible in theory. According to the Federal Ministry of Health, according to the latest Medical Device Ordinance, it is possible for pharmacies to offer self-tests. However, these rapid tests must first be certified for use as a self-test, i.e. have a CE mark, and be listed by the Federal Institute for Drugs and Medical Devices. An essential criterion for such a certification is that the tests can be carried out reliably by laypeople. From the Ministry’s point of view, the quality of implementation is not yet high enough. Therefore, no available rapid test is currently approved as a self-test, although the question of sale has already been settled.
How meaningful are rapid tests now?
In the opinion of many experts, the reliability of many rapid antigen tests has recently been increased – especially with regard to the sensitivity of the tests in people who are infected with the coronavirus and are highly contagious. Manufacturers have also improved manageability. With most rapid tests, the result can be read just as easily as with a pregnancy test. In addition, the industry has made advances in sampling. The test can only determine a correct result if the smear in the throat or nose is correct – this point is particularly important for self-tests. Most recently, however, it was shown that even laypeople can reliably use the swabs with which the sample material is obtained from the nasal cavity. Advancing through the nose into the nasopharynx is no longer necessary for the most comfortable self-tests. In highly contagious infected people, there is enough viral material in the upper nasal septum for a rapid antigen test to work.
How many rapid tests are there on the market?
The availability of rapid antigen tests has multiplied since last summer, and many tests have now been evaluated independently of the manufacturers. The “Diagnostics Global Health” website, founded by Heidelberg doctors, lists the tested tests. The much longer rapid test list maintained by the Federal Office for Drugs and Medical Devices only lists the manufacturer’s specifications that meet some minimum standards. Most of these rapid tests are designed for use by trained personnel only. However, practical self-tests have been validated around the turn of the year. The large manufacturers of rapid tests in Europe had so far held back with their own studies because of the restricted use.