Not for publication in the USA
Siemens Healthineers announced today that the CLINITEST Rapid COVID-19 Antigen Self-Test, which is performed with a swab sample from the nasal cavity, has received temporary special approval from the German Federal Office for Drugs and Medical Devices (BfArM) for self-administration by lay persons in Germany. In addition, the regular conformity assessment procedure for CE marking for self-administration by laypersons has been initiated.
"By making the COVID-19 rapid antigen test available for lay use in Germany, we are breaking new ground and further fulfilling our social responsibility to support a return to social normality," said Bernd Ohnesorge, Head of Region Europe, Middle East and Africa at Siemens Healthineers.
In a study of 50 people without medical training who performed the test on themselves with the help of the instructions for use, the usability was confirmed by lay people. The test already has a CE mark for use by healthcare professionals for nasal sampling.
"The CLINITEST COVID-19 Antigen Self-Test offers users high flexibility in performing the test with very good quality results," said Christoph Pedain, Head of Point of Care Diagnostics at Siemens Healthineers.
The COVID-19 Antigen Self-Test provides results in 15 minutes. It involves taking samples from both nostrils using a swab. The swab is then washed in a reagent, dissolving a specific protein from the surface of the virus. This liquid is dropped into a well in the test cassette. Within 15 minutes, the test sample flows into the field of view of the cassette and becomes visible by a dash. The position and number of lines indicate whether the test result is positive or negative, or whether something was done incorrectly during the test procedure and the test must be repeated.
The tester is shown the steps to be taken to obtain a test result in specific instructions for use. This also includes instructions on how to proceed according to the test result. For example, a negative test result, which is only a snapshot, does not release the tester from Covid-19 related safety measures that are currently in effect.
As soon as the test is available in Germany, a dedicated website with an explanatory video and contact options for test specialists will provide further support to round off the expert advice to be provided by the dispensaries.
Apart from Germany, the personal use of this test - currently time-limited until June 30, 2021 - is permitted in Austria.
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