Siemens Healthineers is launching a rapid and easy-to-use antigen test for the detection of SARS-CoV-2, the virus that causes COVID-19.
The CLINITEST Rapid COVID-19 Antigen Test 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.
96.72 % sensitivity
The CE marked test which has been developed and tested by a Siemens Healthineers partner demonstrated 96.72 % sensitivity and 99.22 % specificity based on a clinical study of 317 subjects.
The study was performed using operators with varied credentials at six diverse sites including a hospital, a community clinic, a college campus, and an oncology unit.
Siemens Healthineers intends to meet such testing demand as the pandemic evolves. There are plans to submit the test for FDA Emergency Use Authorization.