The COVID-19 HOTGEN layman's test / antigen rapid test is easy to use and ensures rapid, qualitative detection of the SARS CoV-2 virus in swab samples. The special feature of this test: A gentle swab in the anterior nasal cavity or throat is already sufficient to provide a reliable result.
In the first special approval according to § 11 paragraph 1 of the Medical Devices Act (MPG), the BfArM has granted approvals for antigen tests for self-administration by laypersons (self-tests) for the detection of SARS-CoV-2. This includes the BOSON Antigen Rapid Test, trade name Rapid SARS-CoV-2 Antigen Test Card, which we now offer. File number special approval: 5640-S-007/21
As of now, the COVID-19 / Corona rapid test from Hotgen is also approved for use by laypersons (private use), i.e. without medical professionals!
The COVID- 19 Hotgen Antigen Rapid Test is easy to use and ensures rapid, qualitative detection of the SARS CoV-2 virus in swab samples. The special feature of this test: A gentle swab in the anterior nasal cavity or in the throat is already sufficient to provide a reliable result.
Until February 2021, only medically trained personnel were allowed to perform a Corona antigen test. Rapid tests were therefore only available from doctors, health facilities, special test lanes or as a pharmacy test.
Since 03.02.2021, rapid tests for self-testing may also be distributed to end consumers or non-medical institutions. However, Federal Minister of Health Jens Spahn has formulated some conditions that a Coronatest for home use must fulfil:
In order to place a rapid test for self-administration on the market, the manufacturer must undergo a precisely defined test procedure. Independent bodies guarantee that the products meet all the required quality criteria. As proof, the product receives a CE marking with reference to the testing body to ensure maximum transparency.
For the transitional period until CE certification, manufacturers can also apply to the Federal Institute for Drugs and Medical Devices (BfArM) for special approval. The authority then also checks whether the Coronatest can be used safely at home by laypersons. Whether CE certification or special approval - the quality requirements for a home test remain the same.
Home tests often contain one and the same test material as those test kits intended for professional users. An important difference, however, is that a home test requires an instruction leaflet written in layman's terms. This contains detailed instructions, usually illustrated with pictures, on how to perform the rapid test correctly. It must also inform the user about what to do after a positive, negative or unclear result. - Normally, a positive antigen test is followed by a PCR laboratory test for confirmation. In addition, the package insert contains the important note that a negative test result is only a snapshot.
The SARS-CoV-2 / COVID-19 test from Boson offers you a safe and quick way to protect your family and friends.
With the Boson self-test, nothing stands in the way of meeting family and friends. Get the Covid-19 lay test now and take an active part in life again!