Siemens Healthineers announced today that the CLINITEST Rapid COVID-19 Antigen Self-Test, which is carried out with a swab sample from the nasal cavity, has received limited special approval from the Federal Office for Drugs and Medical Devices (BfArM) for self-use by laypeople in Germany Has. In addition, the regular conformity assessment procedure for the CE marking was initiated for personal use by laypeople.
With the provision of the COVID-19 antigen rapid test for possible use by laypeople in Germany, we are breaking new ground and are thus continuing to fulfill our social responsibility to support a return to normal social life,"
Bernd Ohnesorge, Head of the Europe Region, Middle East, and Africa, Siemens Healthineers
In a study with 50 people without medical training who carried out the test themselves with the help of the instructions for use, the practicability was confirmed by laypeople. The test already has a CE mark for use by specialist groups for taking samples in the nose.
"The CLINITEST COVID-19 Antigen Self-Test offers users a high degree of flexibility in performing the test with very good quality results," said Christoph Pedain, Head of the Point of Care Diagnostics at Siemens Healthineers.
The COVID-19 Antigen Self-Test delivers results in 15 minutes. For this purpose, samples are taken from both nostrils using a swab. The swab is then washed out in a reagent, which detaches a specific protein from the surface of the virus. This liquid is dripped into a recess in the test cassette.
The test liquid migrates into the field of view of the cassette within 15 minutes and becomes visible as a line. The position and number of lines indicate whether there is a positive or negative test result or whether something was done wrong during the test and the test must be repeated.
The tester is shown the steps to achieve a test result in special instructions for use. This also includes instructions on how to proceed according to the test result. A negative test result, which is only a snapshot, does not release you from the AHA regulations and other local safety measures that are currently valid.
As soon as the test is available in Germany, a special website with an explanatory video and contact options for test specialists will provide further support to round off the expert advice to be guaranteed by the delivery points.
Apart from Germany, personal use of this test is permitted in Austria - currently for a limited time until June 30, 2021.