FDA authorizes first antigen test to rapidly detect COVID-19 virus
The Food and Drug Administration Friday issued the first 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.
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