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Corona rapid tests are intended to increase the number of testing options. Since mid-October 2020, rapid tests for professionals have been allowed, and since February 2021, rapid tests for amateurs at home. What you should know about different types and reliability of rapid tests.
Corona rapid test: First tests approved for everyone
They have been on the market since mid-October 2020: Corona rapid tests. There are different variants: the self-nasal swab, the self-throat swab, the gargle test and also the spit test. All of them are supposed to detect the novel coronavirus in a short time in order to cope with the corona pandemic more quickly. But: There are limitations and discussions about the safety level of these tests.
- The rapid antigen test reacts to the so-called spike protein, which adheres to the surface of the coronavirus. The rapid antigen test offers the possibility to test more and faster. Initially, such tests were only carried out by medical personnel. Not only virologist Christian Drosten called for rapid tests early on, also for home use.
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In the beginning, the tests were mainly available for medical facilities. Visitors as well as employees, residents and patients of hospitals, doctors’ offices or nursing homes could have the rapid test performed.
- Private individuals can get tested at their doctor’s office or at rapid testing centres – if enough tests are available.
- 07 January 2021: The use of a rapid antigen test at home has so far been prohibited by the Infection Protection Act. The reason: Covid-19 is a notifiable disease. But: NanoRepro AG has now submitted a Corona antigen rapid test to the Federal Institute for Drugs and Medical Devices for approval for end customers.
- Compared to previously used corona antigen rapid tests, the NanoRepro home test is to be commercially available and can be performed at home. The saliva test is said to show a result after only 15 to 20 minutes.
- In addition, the handling of the advanced rapid tests is easier. It will not be necessary to insert the stick deep into the throat or nose. Only two centimetres deep must the swab be inserted into the nose. According to studies, the “hit rate” for private individuals is almost identical to that of medically trained personnel.
- Gurgling tests are also an option in this country, and in Austria they are already being used (as of the end of January) in day-care centres and the like. A liquid is gargled for up to one minute, spat into a tube and then examined. The results are very similar to the test via throat swab. There is also the option of a spit test.
- 25 January 2021: Rapid corona tests could soon be available at home in Germany. The Federal Ministry of Health is planning an amendment to the “Medical Devices Dispensing Ordinance”, which will allow easy-to-use tests to be sold to private individuals.
- The USA is a pioneer in the field of rapid corona testing at home. Citizens there have been able to buy such antigen tests in drugstores since December 2020.
- 03 February 2021: Consumers are now allowed to buy Corona rapid tests and perform them themselves. The Federal Ministry of Health has amended the Medical Devices Dispensing Ordinance accordingly. This is reported by the industry service APOTHEKE ADHOC.
- In vitro diagnostics for the pathogen detection of Sars-CoV-2 can be dispensed for self-testing since 03 February. Normally, such products may only be used by specialised personnel in order to exclude false results due to application errors. So far, only HIV self-tests have been approved for free sale. The exemption for Corona antigen tests is limited in time.
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They must be “sufficiently suitable for use by lay persons in terms of safety and performance” so that “the quality of the results can be ensured under these conditions of use”. The information for use and labelling must also be geared towards laypersons.
- Manufacturers have already submitted applications for approval for spit tests, for example. The rapid tests available so far, which involve swabbing, may still only be used by professionals.
- 03 February 2021: Hamburg-based Viromed is the first German company to supply a rapid corona virus test from LYHER that is said to be less unpleasant for patients. In the new Novel Coronavirus Antigen Test, the sample is taken from the front of the nose (2-3 cm) instead of the back of the nasopharynx.
- This new smear method is designed to prevent discomfort, especially in sensitive individuals such as children and the elderly. According to the manufacturer, this makes it suitable for everyday use and for schools and daycare centres, for example.
- 24 February 2021: The Federal Institute for Drugs and Medical Devices has granted the first three special approvals for Corona tests for self-testing by lay people. For all three tests, samples are taken by swabbing the front of the nose. The lay tests will be available in supermarkets and discount stores.
- The following three antigen tests have received approval: CLINITEST Rapid COVID-19 Self-Test (manufacturer: Healgen Scientific), Rapid SARS-CoV-2 Antigen Test Card (manufacturer: Xiamen Boson Biotech) and LYHER® Covid-19 Antigen Rapid Test (manufacturer: Hangzhou Laihe Biotech), according to the Federal Institute for Drugs and Medical Devices.
- Beginning of March 2021: In the meantime, six Corona self-tests have received special approval. Even lay people can use them to test themselves at home.
- 03 March 2021: Corona testing opportunities are to be significantly expanded by early April. Everyone is to be able to take a free rapid test at least once a week. Those who test positive must isolate themselves and take a more reliable PCR test. Both tests should be free of charge.
- 20 January 2022: This tool shows how good your Corona rapid test really is
Controversial: The reliability of the Corona rapid test
The degree of reliability of rapid tests is controversial. Karl Lauterbach initially even believed in an accuracy of 95 per cent, as he told ZDFheute. But: According to scientific findings, one cannot rely on the quick tests and self-tests. Scientists of the National Research Network of University Medicine on COVID-19 are also sceptical.
- In a recent position paper, they warn against the widely used Corona rapid tests (as of 13 January 2021). According to the scientists, the sensitivity of these tests is considerably lower than stated by the manufacturers.
- The Stiftung Patientenschutz (Patient Protection Foundation) takes a similar view, calling for the rapid antigen tests to be checked by independent laboratories. According to this, only tested antigen tests should be used.
- When we talk about rapid tests, we usually mean antigen tests. In the classic rapid test, a swab is taken from the nasopharynx, just as in conventional coronary tests. The sample is put on a test strip. This contains antibodies to which the spike proteins bind.
- But even a negative test is only a snapshot; infection cannot be ruled out with rapid tests. Antigen tests have the advantage of producing a result more quickly and cheaply, but they are also much less reliable.
- The rapid test can therefore not replace the PCR test, as it offers greater reliability. When to use PCR testing and when to use the rapid antigen test is prescribed by the national testing strategy.
- br.de came to the rapid test conclusion that mass testing for the entire population is not useful. Only in individual areas or for people with symptoms could rapid tests help (as of mid-December 2020).
- “Self-tests are not a magic bullet,” said the president of the Robert Koch Institute (RKI), Lothar Wieler. After all, a negative result is merely a snapshot and does not fundamentally rule out an infection. Even if the tests are used correctly, it is “merely less likely” to be infectious to others at that time, according to the RKI.
- Aparticularly in the case of infected people who do not show any symptoms, such as fever or cough, there is definitely a risk that they will receive false results. A team from the international Cochrane Network found that in two rapid test products studied, an average of 72 percent of patients with symptoms were correctly detected, but only 58 percent of those without symptoms. What no one knows for sure, however, is whether or not those with false-negative results would have been infectious to others at all.
- 14 April 2021: Drosten warns of deceptive certainty: ‘Rapid tests less reliable than thought’, between 40 per cent and 60 per cent of infections are missed in rapid tests, says Drosten.
- 30 April 2021: Bill shows: Rapid antigen tests detect only 56.3 per cent of infections
- 07 July 2021: No second line despite infection: rapid antigen tests detect only 42 per cent
- 12 January 2022: Due to rapidly increasing case numbers caused by the Omikron variant, the testing strategy in Germany is now once again coming into focus. For example, the federal government wants to allow early free testing from quarantine not only with PCR tests, but also with “high-quality” antigen tests. However, many experts consider this idea bad and point to the limits of antigen tests. Findings to date show: Particularly at lower viral loads, antigen tests, which include rapid and self-tests, often do not work.
