Quidel’s Sofia SARS Antigen Test Receives EUA for Screening Use with Serial Testing

Quidel Corporation, a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), to market its Sofia® SARS Antigen FIA and the QuickVue® At-Home OTC COVID-19 Test. The Sofia® SARS Antigen FIA is indicated for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from anterior nares swab specimens directly from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms, or are individuals without symptoms or other epidemiological reasons to suspect COVID-19 tested twice over two (or three) days with at least 24 hours (and no more than 36 hours) between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments and is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Read More