FDA authorizes first antigen test to rapidly detect COVID-19 virus

The Food and Drug Administration Friday issued the first emergency use authorization for a COVID-19 antigen test, which can quickly detect the SARS-CoV-2 virus in a nasal swab sample.

Under the EUA, high and moderate complexity laboratories certified under the Clinical Laboratory Improvement Amendments and point-of-care facilities with a CLIA certificate of waiver, compliance or accreditation may use the test, made by Quidel Corporation.

Antigen tests are faster and generally less costly than polymerase chain reaction tests, but have a higher chance of false negatives, meaning negative results may need to be confirmed with a PCR test, FDA said.