Siemens Launches New Rapid COVID-19 Antigen Test for Detection of SARS-CoV-2

Siemens Healthineers (Erlangen, Germany) has launched a rapid and easy-to-use antigen test for the detection of SARS-CoV-2 that helps identify infected individuals in 15 minutes without using specialized laboratory personnel or instruments.

The new CLINITEST Rapid COVID-19 Antigen Test from Siemens is a point-of-care cassette test that does not require laboratory instruments or specialized lab personnel to administer, and it delivers results in 15 minutes. The CLINITEST Rapid COVID-19 Antigen Test is easy to administer for healthcare professionals and delivers results quickly using the nasopharyngeal swab method. Once a sample is collected, the swab is inserted into a tube with special liquid to extract the target molecule. This liquid is then dispensed onto a test cassette and, in 15 minutes, a positive or negative result is clearly indicated.

The CE marked test which has been developed and tested by a Siemens partner demonstrated 96.72 % sensitivity and 99.22 % specificity based on a clinical study of 317 subjects. Siemens will launch the CLINITEST Rapid COVID-19 Antigen Test in CE mark countries and plans to submit the test for FDA Emergency Use Authorization.

“There is a great public need for reliable tests that can quickly identify contagious individuals and help to minimize the spread of COVID-19, especially in high-traffic areas and where people commonly congregate,” said Christoph Pedain, PhD, Head of Point of Care Diagnostics at Siemens Healthineers. “With quality at the forefront of decision makers’ criteria to determine test reliability, it was critical the clinical study for this test assesses variable clinical conditions that can be expected when implementing a rapid antigen test. This rapid antigen test makes testing available to more people across a wider variety of settings, particularly in locations that need to test people quickly such as airports or that have limited access to laboratory resources such as schools.”