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At the end of September, Federal Health Minister Jens Spahn (CDU) still sounded optimistic.
There will be a home test against Covid-19 "foreseeable", he announced.
We'll see whether that will be in four or 16 weeks, says Spahn.
"But I'm very sure we will see."
18 weeks have now passed - and the rapid tests for home use are a long time coming.
Just like a self-test strategy in general.
After all, the Federal Institute for Drugs and Medical Devices (BfArM) has now announced that it is assuming that it will be able to issue “the first special approvals” at the beginning of March.
There are applications for 30 different products with which everyone can test themselves within 15 minutes.
In addition, the approval of further rapid tests for lay use by certification bodies is expected.
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But what does that mean for the population - and the existing lockdown?
The most important questions and answers at a glance.
Why is Germany so late?
In the USA, the FDA, the authority for food and drugs, approved rapid corona tests for private use in mid-December.
In some EU countries, too, the group of those who can carry out the test was expanded significantly earlier than in Germany.
In France, for example, pharmacists have been allowed to take the test since November, even on people without symptoms.
In Germany this has only been possible for almost four weeks.
Corona self-tests for schoolchildren have been used in Austria since mid-January - here a nine-year-old with his father from Vienna
Source: pa / ANJA OBERKOFL / ANJA OBERKOFLER
Basically, the rapid antigen tests in this country have so far only been allowed to be carried out by medical specialists, mostly in hospitals and nursing homes.
A first exception was made at the beginning of December for educators and teachers, provided they had previously participated in a training course.
With a recent change in the law, everyone is now allowed to test themselves.
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But before that happens, the tests need a separate approval or certification as a medical product so that - as the federal government emphasizes - quality and usability are ensured.
The background to this is the concern of politicians that citizens could carry out the tests incorrectly and that infections remain undetected.
And, according to the Association of the Diagnostics Industry (VDGH), manufacturers have only been able to submit their self-tests for certification since the change in the law made it clear that they could also be used by laypeople.
What kind of rapid tests are they?
A number of test options are in prospect - the manufacturers do not disclose details during the certification process in order not to give competitors an advantage.
But the procedures are usually supposed to be simpler than the tests performed by medical personnel.
The classic is the nasopharynx swab, which is also taken with the usual PCR test.
This is not self-explanatory in its implementation and is usually uncomfortable for those affected.
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For this reason, tests are being prepared that only require a smear in the anterior nasal area in order to provide reliable results.
But even with gargle, spit and saliva tests, antigens can probably be detected quickly.
This would be an alternative especially for children.
However, experts point out that the spit tests require a secretion deep from the airways.
Where should the rapid tests be used?
Since there is no test strategy, there will be no uniform procedure.
For now, at least.
But members of the Bundestag urge to concentrate on certain groups and use cases - if only because the number of test kits is not unlimited.
“Basically, after the lockdown is relaxed, it should be mandatory for institutions to offer approved self-tests when they reopen.
This applies to trade, cultural institutions, especially schools, but also to companies, ”says the SPD parliamentary group vice-president in the Bundestag, Bärbel Bas.
"It should be compulsory and part of the respective hygiene concept that such self-tests are carried out before a large number of people are allowed access again."
"Rapid tests are the most suitable means of all"
The doctor Dr.
Lisa Federle is the pandemic officer for the Tübingen district.
Federle believes that there is no alternative to the consistent and regular use of rapid tests, even for schoolchildren before class, in the fight against the virus.
Source: WELT / Thomas Klug
The Green health politician Janosch Dahmen names three groups that should be tested regularly and with priority: “Risk groups that need special protection, including in nursing homes and hospitals.
Second, people in high-risk professions who have a lot of contact with other people, for example in delivery services.
The third focus is daycare centers and schools - and there staff, children and young people and parents, ”says Dahmen, who is himself an emergency doctor.
Are there sufficient production capacities available?
The authorities do not record all manufacturers who produce corona tests.
Because they can also have their products certified by independent testing companies such as TÜV or Dekra.
Therefore there is no complete overview of producers and production capacities.
A large number of providers are active in the business of corresponding tests.
The Federal Institute for Drugs and Medical Devices has registered 179 manufacturers of corona tests alone, which are carried out by trained personnel.
These are companies from all over the world.
Not all of them will develop self-tests, but there will probably be no shortage of providers.
But there could be bottlenecks for other reasons.
Since many manufacturers apply for approval at the same time following the latest change in the law, the auditing companies are apparently overburdened.
This conclusion arises at least from the fact that so far 30 providers have switched to the Federal Institute - which is not the usual way.
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The authority also issues approvals and, according to its own information, even faster than the private authorities.
But only for a limited time and not for the whole EU, but only for Germany.
Companies only choose this route in exceptional cases - or when things have to go very quickly.
How much do rapid tests cost and where can they be bought?
Health Minister Spahn is just as cautious about the price of self-tests - and who bears the costs.
The pricing is open - as is the extent to which the federal government may support the purchase, said Spahn.
It has not been said whether the federal government will intervene in pricing at all.
Self-tests are currently available in bulk packs from five euros each.
The question is whether the manufacturers are not using the rapidly increasing demand to raise prices.
There is no legal regulation where the tests are sold.
The providers can do this via pharmacies, the Internet and, for example, drugstores.
What happens after a positive test result?
As part of the national test strategy, around 1.5 million PCR tests are currently carried out every week.
This test, known as the "gold standard", only tests people with symptoms and their close contacts.
In October, the test strategy was expanded to include the use of antigen tests.
However, their sensitivity and specificity are lower.
A positive result in the antigen test must therefore always be confirmed by means of PCR.
This also applies to the new self-tests.
For the Robert Koch Institute (RKI), the test results are an important point of reference for assessing the epidemiological development.
It is therefore important to collect data on the use of rapid antigen tests in Germany, says a spokeswoman.
For this purpose, the query in laboratories has been expanded.
The problem: Since very few rapid tests are carried out directly in laboratories, the information transmitted here is only of limited relevance.
With regard to the evaluation of the test strategy as well as the epidemiological situation, the recording of rapid test results is important, for example in care facilities, medical practices or emergency services, explains the RKI.
"The diversity of these areas of application, however, poses a challenge for establishing contact to transfer the data." Since the end of 2020, the RKI has therefore carried out a weekly online query in the facilities.
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At present, however, only around 95 institutions nationwide are participating in the survey, the RKI announced.
A representative statement on the use of the rapid antigen tests is therefore “currently not possible”.
The majority of the tests carried out at private test stations are therefore not included in the statistics.
This dark field is likely to expand when self-tests for home use are added from March.
How can rapid tests ensure safety in daycare centers and schools?
Federal Family Minister Franziska Giffey (SPD) has high hopes for the use of self-tests in daycare centers and schools.
This is a good way to bridge the time to vaccination.
The self-tests are a “real game changer” to bring more children back into regular operations and still ensure the greatest possible safety for the staff, said the minister on Monday during a visit to a daycare center in Potsdam.
People spit before work - day care centers on self-tests
In order to further limit the risk of infection, a day-care center in Potsdam uses so-called "spit rapid tests".
Every employee uses it to test himself for Corona - at home before starting work.
Source: WELT / Dagmar Böhning
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In the Brandenburg state capital, a model project has been running for two weeks with spitting tests that produce a result within 15 minutes.
The city's 2500 educators test themselves twice a week. So far, seven self-tests have been positive, but six of them were negative in the confirmatory PCR tests;
a result is still pending.
Giffey has high hopes for the lay tests, especially since the long day-care center and school closings could lead to loneliness, a depressed mood and a lack of exercise in the children.
With the lay tests, schoolchildren could also be tested across the board.
The mass tests are already being prepared in Berlin.
"We will procure ten million rapid tests for schools and day-care centers," announced Health Senator Dilek Kalayci (SPD).
"The self-tests help to get an even more precise overview of the infection process and to contain the spread."
It is planned that all teachers and students and all daycare workers at Berlin daycare centers will test themselves twice a week.
According to the health administration, 32 million euros are initially planned for this in the coming months.
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