Antigen tests are a new category of tests that can quickly detect fragments of proteins from the virus in samples collected by swab from people's noses.
MONDAY, May 11, 2020 (HealthDay News) -- The first emergency use authorization for a COVID-19 antigen test has been issued by the U.S. Food and Drug Administration.
Antigen tests are a new category of tests for use in the coronavirus pandemic and quickly detect fragments of proteins from the virus in samples collected by swab from people's noses.
The approval was issued Friday to the Quidel Corp. for the Sofia SARS Antigen FIA, which is "authorized for use in high and moderate complexity laboratories certified by Clinical Laboratory Improvement Amendments (CLIA), as well as for point-of-care [ie, doctor's office] testing," according to an FDA news release.
"I am very enthusiastic about antigen testing because of its ability to be scaled up to millions of tests a day, and because it has a much more rapid turnaround," Dr. Ashish Jha, director of the Harvard Global Health Institute, told The New York Times. "A lot of us have been looking forward to this moment."