Here you will find information about the antigen rapid tests that are available in our online shop. The Hotgen self-test (home test) is only available in Germany.
Antigen tests are an ideal complement to PCR tests thanks to their rapid test results. PCR tests are not only more elaborate, but also require more time before a result can be delivered. This is why antigen tests offer a great advantage when it comes to visiting a nursing home or hospital, for example. By using the tests regularly, highly infectious individuals can be found more quickly, preventing further infections. Regular antigen testing is also useful for maintaining important businesses or schools. However, one should still be aware that a negative result does not always mean that one is not infected, as antigen tests do not have the same sensitivity as PCR tests. In this case, the viral load may still be too low, but this also means that the person is less infectious.
For the antigen test, as for the PCR test, sample material is first taken, e.g. from a nasal swab. The sample is then brought into contact with a test liquid. This test liquid is then applied to the sample well of the rapid test and the result can be read after approx. 15-20 minutes. If viral antigen was present in the sample taken, this is indicated by a colour reaction, similar to a pregnancy test.
Since the result of the rapid antigen test only provides a snapshot of the current infectivity, the test should be repeated regularly. The amount and frequency of contacts also depends on the individual. Depending on the situation, it may make sense to test twice a week or even daily.
The main difference between the two here lies mainly in the statement that you get from the test result. A rapid antibody test detects whether a person has already contracted Covid-19 and has subsequently formed antibodies against the virus. However, an antigen test directly detects viral proteins. This makes it possible to test whether a person has Covid-19 and is secreting virus particles at the moment of testing and is therefore infectious. This means that a current infection can be detected. This is not possible with an antibody test.
Yes, even with the two new virus variants B.1.1.7 and B.1.351, the rapid antigen tests can still provide reliable results. Recently, two new virus variants have been detected that have multiple mutations, making them more infectious than the original SARS-CoV-2 variant according to current data. Most of the mutations in these new variants affect the spike protein, which occurs on the surface of the viruses and is responsible for entry into the human cell. Unlike the currently used vaccines, the rapid antigen tests do not detect and identify the spike protein but the nucleocapsid protein. This nucleocapsid protein encloses the viral RNA inside the virus. Mutations can also occur here, but these occur very rarely compared to the spike protein. In the case of the new variants from the United Kingdom (B.1.1.7) and South Africa (B.1.351), the rapid tests can therefore still effectively detect the viral proteins.
Sensitivity: This indicates whether persons with the disease are actually detected as such. If the sensitivity of a test is given as 98%, this means that 98 out of 100 infected persons were detected, but the disease was not detected in 2 persons. These people therefore receive a negative test result, although they are infected. Such results are also called "false-negative".
Specificity: This describes the accuracy of a test. This means that uninfected persons are detected as healthy persons. If a test has a 97% specificity, this means that 97 out of 100 people got a correct negative test result. However, three people got a positive result although they are not infected and are healthy. Such results are also called "false positives". Most tests have a specificity of 99-100%, so positive results in "non-infected" patients are very rare.
You must immediately self-isolate and inform the responsible public health authorities. In Germany, you can also contact the on-call health service (116117). They can inform you about the steps you should take and can give you an appointment for a PCR test to confirm the antigen positive result.
A rapid antigen test is just a "snapshot". Even if the test is negative, you could be infected but your viral load is still too low to be detected. If this is the case, you could still become contagious shortly after taking the test. That is why you should carry out rapid antigen tests regularly and should continue to follow hygiene measures, such as social distancing, wearing a mask and using hand sanitizer.
This means that the test result is invalid. Please repeat the test with a new test kit according to its instructions leaflet.
You can dispose of the test components in the residual waste. As this is potentially infectious material, the test components should be securely packaged in an extra bag and placed with the rest of the waste in a well-sealed container.
Nasopharyngeal swab = The swab is inserted almost horizontally along the nasal septum into the nose until the resistance of the pharyngeal wall is felt. After a short rotation, the swab is then removed again.
Oral pharyngeal swab = First, the tongue is pressed down with a spatula. The swab is then swiped along the pharyngeal wall with a rotating movement.
As these two sampling procedures are quite uncomfortable and difficult to perform alone, home rapid tests will use non-invasive methods to collect the sample.
Non-invasive sample collection methods include:
Nasal swab (Nasal) = The swab is inserted into the nose parallel to the palate up to the turbinate about 1.5-2 cm. After a few rotating movements, the swab is removed and the same procedure is repeated for the second nostril.
Gargling, spitting and sucking tests = By gargling for 30 seconds or by clearing the throat, saliva is first released from the pharynx, which is then spat into the collection container. A longer accumulation of saliva material in the oral cavity is also possible with some test procedures as well as the use of so-called "lollipops", which absorb the saliva material directly in the oral cavity.
The sample collection for rapid antigen tests for professional users is usually done via a nasal or oral pharyngeal swab, which is quite unpleasant and can only be performed by a second person. Likewise, the instructions and product description are geared towards medical personnel, which makes it difficult to understand for people who have little or no knowledge in this area.
The amendment to the Medical Devices Dispensing Ordinance of 03.02.2021 now also allows the dispensing of rapid antigen tests for private individuals. However, these antigen tests require separate testing and approval in Germany. The sample collection for such antigen self-tests is non-invasive and takes place either via saliva as a spit test or via an anterior nasal swab. The main difference is therefore the simplified sample collection and the fact that no second person is necessary. Instructions and product descriptions are also checked during the approval process to ensure that they are easy to understand and easy to perform.
There are two kinds of antigen rapid tests: tests that can be performed by anyone and tests that have to be carried out by a healthcare professional.
Rapid antigen test for professional users:
According to the requirements of the Medical Devices Operator Ordinance, these may be carried out by persons who have the necessary training or knowledge and experience and have been instructed in the medical device to be used (§ 4 Paragraph 5 in conjunction with Paragraph 2 MPBetreibV).
Antigen self-tests (home tests):
The rapid antigen tests that have received special approval for self-testing may also be performed by private individuals at home.
It all depends on whether the respective test has been approved as a rapid antigen test to be performed by professionals or as an antigen self-test (which can be performed by anyone).
Rapid antigen tests for professional users may only be supplied to physicians, medical institutions, educational institutions, government agencies and companies, critical infrastructure and other institutions according to the Medical Devices Dispensing Ordinance to be dispensed. Since the 4th amendment to the Veordnung on 16.03.2021, these rapid antigen tests may also be dispensed to employers. The test may then be carried out by persons who have the necessary training or knowledge and experience and who have been instructed in the medical device to be used (§ 4 Paragraph 5 in conjunction with Paragraph 2 MPBetreibV).The Federal Ministry of Health has issued an exemplary list of persons and institutions to whom rapid antigen tests for professional users may be supplied, which you can find at here.
Antigen tests that have received special approval to be used at home (also known as antigen self-tests) can be purchased and performed by private individuals. Currently, 8 products have received this special approval (as of mid-March 2021).
The result of the antigen test depends on the viral load in the sample taken. Especially if the viral load is very high, i.e. a person is very infectious and the probability of infecting other people is very high, this is also indicated by a positive test result in the antigen test. Only in the early as well as the final phase of the infection, when not very many viruses are detectable, it is possible that they will not be detected by a rapid antigen test. However, in this phase the infected person is also no longer highly contagious.