FAQ2021-03-15T15:46:15+01:00

FAQ – Frequently Asked Questions

What is the difference between PCR tests, rapid antigen tests and self-tests?2021-03-15T13:20:25+01:00

PCR tests represent the “gold standard” of corona tests, because the test results are the most accurate. The swabbing will be conducted by medical personnel – and the analysis by laboratories.

Rapid antigen tests for SARS-CoV-2 are conducted in a similar way as pregnancy tests. They can only be conducted by trained personnel. Similar to the PCR test, the swabbing takes place in the nose or throat. The test result will be available within 15 minutes.

Self-tests can be conducted by the private person. The swabbing and testing method must be accordingly simpleso that the layperson can make no mistake.

How do I recognize a good rapid antigen test?2021-03-15T13:28:30+01:00

Compared to PCR tests, a rapid antigen test is less sensitive and specific. Rapid antigen tests are of high quality, when they result in as few as possible false-negative and false-positive test results. This means a sensitivity >90% and a specificity >98%.

Our products are clinically proven through various studies and depict a sensitivity between 96.5% (Technomed) and 98.0% (Green Spring). The specificity is also very high: 99.0% for the Technomed test und 100.0 % for the Green Spring test.

Rapid antigen tests, certified by the EU with the CE label, are marketed without further licenses or certificates being necessary. This is why the federal institute for pharmaceutical products, the “Bundesinstitut für Arzneimittel (BfArM)” has created a list of certified products. Only products for which the performance data points are in accordance with the criteria by the Paul-Ehrlich-Institute (PEI) are included in this list.

The rapid antigen tests offered by us are listed with the BfArM and evaluated by the PEI.

Who can conduct rapid antigen tests?2021-03-15T13:31:27+01:00

On February 2nd, 2021 the Third Regulation to amend the delivery regulation for medical products (MPAV) became effective. In this regulation, in-vitro diagnostics were exempt from the limitation to the medical profession and thus qualified for the use by non-medical personnel.

End of February, The federal institute for pharmaceutical products (BfArM) has issued the first special permits, including the Technomed rapid antigen test manufactured by Xiamen Boson Biotech Co., Ltd. According to §11 paragraph 1 medical products law (MPG), rapid antigen tests with this special permit can be used by the layperson to detect an infection with SARS-CoV-2. Further special permits will follow in the next days.

The majority of rapid antigen tests, however, must be conducted by medical professionals – and industrial safety measures must be adhered with.

Especially a correct execution of the swabbing phase, when the infected tissue is taken with the swab from the throat or nose. In case the swabbing sample is not gathered in the correct way, the test result can be false.

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