NEW YORK ─ Siemens Healthineers said on Wednesday that it has received CE marking for its Clinitest Rapid COVID-19 Antigen Test for the detection of SARS-CoV-2.
The company has launched the test, which helps to identify infected individuals in 15 minutes, in Europe and other regions that accept the CE mark.
Erlangen, Germany-based Siemens Healthineers said its antigen assay is a point-of-care cassette test that does not require laboratory instruments or specialized lab personnel to be performed.
The test is easy to administer for healthcare professionals and delivers results quickly using a nasopharyngeal swab, the firm said.
Once a sample is collected, the swab is inserted into a tube with a liquid to extract the target molecule, which is then dispensed onto a test cassette that indicates a positive or negative result.
The company said that the test has been developed and evaluated by an undisclosed partner and demonstrated 96.72 percent sensitivity and 99.22 percent specificity based on a clinical study of 317 subjects.
Operators with varied credentials participated in the study at six sites including a hospital, a community clinic, a college campus, and an oncology unit.
"With quality at the forefront of decision makers’ criteria to determine test reliability, it was critical the clinical study for this test [assessed] variable clinical conditions that can be expected when implementing a rapid antigen test," Christoph Pedain, head of point-of-care diagnostics at Siemens Healthineers, said in a statement. "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."
Siemens Healthineers said it has plans to submit the antigen test for US Food and Drug Administration Emergency Use Authorization.