The U.S. Food and Drug Administration (FDA) has approved emergency use authorization (EUA) to American company Quidel Corp for the first COVID-19 antigen test.
The EUA was issued late Friday to Quidel for the Sofia 2 SARS Antigen FIA, according to the agency.
It is a rapid point-of-care test to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of SARS-CoV-2, the virus causes COVID-19, in nasal or nasopharyngeal specimens from COVID-19 patients, said Quidel in a release.
The SARS Antigen FIA is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings, said the FDA. The test is only for use under the EUA.
The Sofia 2 SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from SARS-CoV and SARS-CoV-2, according to the FDA.
This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses, said the FDA.
