Rapid Antigen Tests for Laypersons
An amendment to the Medical Devices Dispensing Ordinance regarding in vitro diagnostics for the detection of SARS-CoV-2 paved the way for non-professional self-tests at the beginning of 2021. At the end of February 2021, the BfArM (German Federal Institute for Drugs and Medical Devices) issued the first special approvals for SARS-CoV-2 rapid tests that can be performed by non-professionals without assistance. Shortly afterwards, around the beginning of March, the antigen tests for home use were then commercially available for private users.
Most non-professional tests are carried out with swab material from the anterior nasal region. On the one hand, this ensures that the test can be performed independently by any user, and on the other hand, the risk of injury is significantly reduced compared to a swab from the posterior nasopharynx.
Advantages of Corona Rapid Tests for Self-Application
Corona tests, which can be carried out by the users themselves, offer many advantages not only in the private sector but also within companies, schools and public institutions. Whereas until recently the test had to be carried out by a specially trained specialist and the test capacity was therefore very limited by the time factor, now anyone can perform the Covid-19 test themselves, from the smear test to the evaluation. This means that a high number of people can be tested in a short period of time.
The gentle sampling in the anterior nasal region is another important advantage - especially if the test needs to be conducted at regular intervals. Thanks to the painless, much more pleasant smear test method, many people are more willing to perform a self-test.
In contrast to the PCR test, the result of antigen tests is not available the next day, but within a few minutes. This enables a prompt reaction to an infection with the Corona virus and the necessary steps can be initiated.
Sensitivity and Specificity of the Corona Antigen Rapid Test
There are two important indicators for rapid tests that provide information on how reliably the test indicates an actual positive or an actual negative result: sensitivity and specificity.
Sensitivity is a value that indicates the percentage of infected persons for whom the test in fact indicates a positive test result. The higher the sensitivity, the more reliably a COVID-19 rapid test detects persons infected with the coronavirus SAS-CoV-2.
Specificity is a value that indicates the likelihood that a healthy, uninfected person will receive a corresponding negative test result. The higher the specificity, the lower the number of uninfected people who receive a false-positive test result.
Therefore, when purchasing self-tests for the detection of corona infection, care should be taken to ensure that both sensitivity and specificity are as close to 100% as possible to eliminate the occurrence of false-positive and false-negative results as much as possible.
At Praxisdienst you will find a steadily growing selection of antigen lateral flow tests for the detection of SARS-CoV-2 infection. Of course, all the non-professional rapid tests available from us, such as theRoche SARS-CoV-2 Antigen Self-Test, have a special approval from the BfArM.