The Corona self-test has been available for free sale since March 2021: Aldi was the first discounter in Germany to give its customers access. Rossmann and dm, who offer corona self-tests in their branches as well as online, as well as Lidl and Tchibo and online pharmacies such as Pharmeo and Aponeo, provided even more supplies. Even Amazon is now conducting quick tests. But how exactly do they work? And which variants has the Federal Institute for Drugs approved? We have summarized the most important questions and answers for you below.
The Federal Institute for Drugs and Medical Devices (BfArM) has now released countless corona self-tests for home use. In this list of special approvals for tests for self-application by laypersons you will find all products that can now officially be carried out in your own four walls without medical personnel.
With the release of corona self-tests for private use, the risk increases that there will soon be many counterfeits on the market - in addition to the official special approvals. For this reason, new products such as respirators should have a CE mark. This is awarded by TÜV or Dekra, for example, and means that the protection and quality standards applicable in Europe have been complied with. The Federal Institute for Drugs and Medical Devices provides the following information: "The designation for self-use by laypersons requires a completed conformity assessment procedure in accordance with IVDD 98/79/EC Annex III point 6 involving a notified body (recognizable by the 4-digit identification number of the notified body involved). Place next to the CE mark, it must be specified both on the outer packaging and in the instructions for use) or a special approval of the BfArM according to § 11 paragraph 1 Medical Devices Act (MPG)". In other words, a corona self-test must either have CE certification or special approval.
It is important for you to know that a corona self-test is not as precise as a PCR test, which may only be carried out by trained personnel. The result is a snapshot and does not give you 100% certainty that you are not actually infected. The over-the-counter tests do not recognize the genetic material of the virus (RNA), but rather antigens – i.e. protein fragments (proteins) of the pathogen. Nevertheless, a self-test makes sense because it can significantly reduce the risk of unknowingly infecting other people. This is also shown by a study by the Berlin Charité on antigen tests carried out by laypersons last year. The result was that 33 out of 40 people infected with corona could be identified.
The self-tests were developed in such a way that they can be used by laypersons – i.e. people who have not been trained or medically trained. It should be so easy to use that even people with disabilities or children can understand how to carry it out. The tests can best detect an infection just before the onset of symptoms or with the onset of symptoms. A Corona self-test gives you and those around you more security - for example before a planned family visit. However, the distance and hygiene rules must continue to be observed even with a negative test result.
A corona self-test, which is now available in many online shops and pharmacies, is suitable for the so-called nasal swab. How exactly the test must be used is described in detail in the respective manufacturer's instructions for use. In any case, it is important that you follow the individual steps exactly - the more precise the implementation, the more accurate the test result. After you have done the rapid corona test, you usually have to wait 15 to 20 minutes before you see the result.
The following is an example of how to correctly use Aponeo's Hotgen Coronavirus 2019-nCoV antigen self-test:
By twisting the cap, you open the extraction buffer to pour the contents completely into the extraction tube.
Now insert the swab into the extraction tube with the liquid and rotate it several times - and let it rest for a minute. Then squeeze the tube to squeeze the remaining solution out of the swab. Now dispose of the swab and close the tube with the cap (incl. dropper).
Before using the test kit, it should be brought to room temperature. You can then open the pouch and take out the cassette. Place it on a flat surface and start the Corona self-test without hesitation.
Open the extraction tube and carefully add three drops to the sample well (S). Make sure that no air bubbles form on it. Now wait 20 minutes before taking the test result from the sample
The result: If two colored lines appear, one in the control area (C) and one in the test area (T), the test is valid and positive. If only one color line appears in the control area (C) and none in the test area (T), the test is valid and negative. If no color line appears in the control area (C), the test is invalid and invalid.
If the corona self-test shows you a positive result, you should first keep calm. In order to be sure that you have really been infected, a PCR test must be carried out. To do this, call the health department or your family doctor and make an appointment - please do not visit a public test station. After you have been tested, you must quarantine immediately pending the final test result. If you have tested positive for the corona virus again, the quarantine conditions apply to you. Here you will find an overview of how to behave in the event of a positive test result. If the result is negative, however, this is unfortunately still no guarantee that you have not become infected. However, the probability decreases. Nevertheless, it is important that you continue to pay attention to yourself and your environment.
Another important note: A corona self-test does not replace the AHA-L rules. In order to protect ourselves and our surroundings to the best of our knowledge and belief, we must continue to adhere to all applicable hygiene measures.
Sources: BfArM, Apotheken Umschau, Robert Koch Institute
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