First special approval for Corona self-tests

style="float: right; margin-bottom: 10px; font-weight: 600;"Wed 24th Feb, 2021

The Federal Institute for Drugs and Medical Devices has granted the first three special approvals for Corona tests for self-administration by laypersons. A spokesman made the announcement on Wednesday. In all three tests, samples would be taken by swabbing the front of the nose. This can be carried out safely by laypersons according to the studies presented by the manufacturers, the Federal Institute further explained.

Before granting a special approval, the Federal Institute not only checks the technical functioning of the test, it also looks at whether the test can be used safely by laypersons. This includes, among other things, comprehensible operating instructions. Since February 2nd, the previously available Corona rapid tests have also been approved for use by non-medical personnel following training.

The federal institute had received nearly 30 applications for special approval of corresponding rapid tests for laypersons by Feb. 12th. The applications were to be reviewed with the highest priority in order to make the rapid tests available as soon as possible.

To ensure that the tests can be used safely by laypeople and make an effective contribution to pandemic control, diligence is the overriding principle in the testing procedures, the federal institute explained. Federal Health Minister Jens Spahn (CDU) told ZDF television on Wednesday morning, "I expect that we will be able to issue further special approvals as early as next week."

When new medical devices are approved in the regular procedure, certification bodies issue the CE marking. Irrespective of the special approvals, the Federal Institute also expects further applications for approval of antigen tests for lay use to be submitted via the regular route.

Alongside vaccinations, rapid tests are considered to be an important component in containing the pandemic. The issue has gained further importance due to the rapid spread of the British Corona variant, which is considered to be even more contagious and was first discovered in the UK, as well as the steps taken to open daycare centers and schools.

Health Minister Spahn, in turn, is now recommending a combination of more rapid tests as well as self-tests for everyone. "There are now significantly more rapid tests and now additionally self-tests available," he said. Therein lies an opportunity at this stage of the pandemic - even with more contagious viral mutations, he said. "With more testing, we can find previously undetected infections."

On rapid tests, which must be taken by trained personnel, Spahn explained, "More rapid tests can help us get more security in everyday life. If we want to visit grandmother, for people in need of care in the home or when traveling." These tests by trained third parties would make sense where there is a need for confirmed proof of the result. To this end, they should be available at low cost and free of charge.

Self-tests, on the other hand, could provide security in specific situations, Spahn said: "Before you attend an event, get a haircut or go to the theater."

Photo by Guido Hofmann


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