Siemens Healthineers launched a "rapid and easy-to-use" antigen test kit in Europe for the detection of SARS-CoV-2, the novel coronavirus that causes COVID-19, the German medical technology company announced on Wednesday.
According to Siemens Healthineers, the point-of-care cassette test kit did not require laboratory instruments or specialized lab personnel to administer and delivered results in 15 minutes.
"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, head of Point of Care Diagnostics at Siemens Healthineers in a statement.
The rapid antigen test kit with a European CE marking demonstrated 96.72 percent sensitivity and 99.22 percent specificity in a clinical study of 317 subjects, according to Siemens Healthineers.
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 also planned to submit the rapid test to the Food and Drug Administration (FDA) for emergency use authorization in the United States.
The rapid antigen test kit would enable testing across a wider variety of settings, added Pedain, "particularly in locations that need to test people quickly such as airports or that have limited access to laboratory resources such as schools."
