Siemens Healthineers Nabs CE Mark for Rapid COVID-19 Test
Siemens Healthineers has announced that it earned a CE mark certification for its Clinitest rapid COVID-19 antigen test.
The test provides results in about 15 minutes without the need for specialized laboratory staff or equipment, allowing it to be used in point-of-care settings. It is administered by healthcare professionals and uses nasopharyngeal swabs.
The rapid test can be used at “locations that need to test people quickly, such as airports, or that have limited access to laboratory resources,” said Christoph Pedain, head of Siemens Healthineers’ point-of-care diagnostics.
The company said it plans to seek an Emergency Use Authorization from the FDA.