Quidel Sofia SARS Antigen FIA

The Sofia SARS Antigen FIA* is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when 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 of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test 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.

Test type: lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instruments intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2
Specimen type: Anterior nasal swab specimens
Turnaround time: 15 minutes
CLIA complexity: Waived, Moderate, or HighFDA status: Emergency Use Authorization (EUA) Granted