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.
