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Corona rapid tests at home: Ministry of Health clears the way

2021-02-04T15:43:05.412Z


Corona rapid tests for domestic use have been allowed in Germany since Wednesday. When can you buy them? And what role could the self-tests play in the pandemic? An overview.


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Photo: Christopher Hopefitch / Getty Images

A simple corona rapid test at home - that would make a lot of things easier and could possibly help to get out of the pandemic faster.

Up until now, rapid tests for the coronavirus were only allowed to be carried out officially in Germany by medically trained staff.

Now the Federal Ministry of Health has paved the way for self-tests at home with an amendment to the medical device dispensing regulation.

As soon as the manufacturers have the appropriate approval, they can sell their tests to laypeople.

What does this mean for the development of the pandemic?

What tests are you talking about?

And how safe are you?

Answers to the most important questions.

Which tests are you talking about?

So-called antigen rapid tests should be available.

These do not detect Sars-CoV-2 itself, but proteins associated with the virus.

So far, these tests have only been approved for professional use by trained personnel, as a nasopharynx smear usually has to be taken.

Firstly, this is uncomfortable and, secondly, it is not very easy to implement for the layperson.

But tests that only require nasal secretions are now also being developed.

Antigens can also be detected quickly using gargle or saliva tests, previously known as PCR tests.

How good are the lay tests?

That depends on the handling.

Where and how must the sample be taken?

How good are the instructions?

In autumn, the Berlin Charité and the Heidelberg University Hospital examined how around 150 suspected corona patients fared when dealing with a self-test and instructions that were not yet on the market.

In this procedure, the swab in the anterior nasal area had to be guided along the inner walls of the nose at a depth of two to three centimeters for 15 seconds in circular movements.

The result: According to the study, 29 out of 39 infected people were detected during the self-test, and 31 when using specialist staff. The self-tests had a sensitivity of 74.4 percent and the professionally approved tests of 79.5 percent.

Do all quick tests have such a high error rate?

The Paul Ehrlich Institute (PEI) and the Robert Koch Institute (RKI) have defined minimum criteria according to which antigen tests must have at least a sensitivity of more than 80 percent and a specificity of more than 97 percent in order to be used in Germany come.

What does that mean?

A test with a sensitivity of around 80 percent does not recognize 20 out of 100 corona positives.

So you believe you are not infected, but you carry the virus within you and can therefore pass it on.

The specificity indicates how many uninfected people are actually recognized as not infected.

The Federal Institute for Drugs and Medical Devices (BfArM) maintains a checked list of all manufacturers whose tests meet the criteria.

What role could rapid tests play in the pandemic?

Most experts agree: Rapid tests cannot replace PCR tests, but they can complement them.

The most important difference is that PCR tests are very sensitive and can show a positive result even with a low concentration of viruses.

Antigen tests, on the other hand, require a large amount of virus.

It is therefore conceivable that the tests close a gap that exists in the current test strategy: If someone develops symptoms - and therefore probably has a relatively high virus concentration - he sometimes has to spend some time on the PCR test and, above all, on the result waiting.

An antigen test would provide a result within a very short time.

If it is positive, it would be clear to the person concerned that he must first go into quarantine and contact his family doctor and the health department.

The Federal Association of German Pharmacists' Associations (Abda) says that only a PCR test from the laboratory can "reliably confirm the result of the rapid test and thus precisely map the infection process".

The SPD health expert Karl Lauterbach also called for regular tests in companies: »Studies show very clearly: If you were to test the workforce of the companies twice a week with an antigen test, so to speak at the start of work - those who are not in the home office - then would you can massively reduce the number of new infections, «he said in an interview with RTL / n-tv.

Are there any quick tests to buy at home?

"So far, there are no lay-compatible rapid antibody tests on the market," says Ursula Sellerberg from Abda.

"There is a lot of demand, but we still have to put the customers off." The reason: Although rapid antigen tests for the coronavirus are already available, these are only approved for use by trained staff.

Self-tests - such as blood sugar tests for diabetics - have to go through a special test procedure in Germany in order to receive a CE mark.

At the request of the dpa, the Association of the Diagnostics Industry announced: "It is also the case, as far as we know, that - at least in Germany - no test for self-use has yet been CE-marked." It is assumed that it will probably be a few more weeks will take until the first manufacturers bring such tests on the market.

With the CE mark, manufacturers ensure compliance with European protection and quality standards.

A four-digit number after the CE mark also indicates that the product has been certified by an independent testing agency such as TÜV or Dekra.

Alternatively, it is also possible to apply for a special permit from the BfArM.

Incoming applications would be treated with the highest priority, BfArM press spokesman Maik Pommer assured SPIEGEL.

"Of course, we have to ensure that a test is not only feasible, robust and safe for laypeople, but that laypeople can also come to a reliable result."

The companies are working “at high pressure” on the approval of such tests, said the managing director of the Association of the Diagnostics Industry, Martin Walger.

According to him, it is conceivable that, in addition to gargle tests, the current rapid tests with the long chopsticks will also be approved for private use.

What does such a test cost?

Regarding the possible prices of the self-tests, the pharmacists' associations said that these would be individually calculated and reported by each manufacturer and also by each pharmacy, especially since the tests also differ in their quality and handling.

Anyone who is currently having an official rapid test also pays the staff.

For example, the cost of this at Hamburg Airport is 39.90 euros, while at Munich Airport it is 73.27 euros.

The prices of tests from various manufacturers that can be ordered online and carried out by medically trained people also vary widely.

There are bulk packs with 25 tests at one dealer for 214 euros, the next they cost 260 euros.

Icon: The mirror

With material from dpa

Source: spiegel

All tech articles on 2021-02-04

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