Uses advanced immunofluorescence-based lateral-flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2. The Sofia SARS Antigen FIA, with the Sofia 2 and Sofia analyzers, provides automated and objective results in 15 minutes, allowing for COVID-19 testing of symptomatic patients within the first 5 days of symptoms and asymptomatic patients when tested serially.
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This test has not been FDA cleared or approved.
The test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by Authorized Laboratories.
"Authorized Laboratories" Include laboratories certified under The Clinical Laboratory Improvement Amendments Of 1988 (CLIA), 42U.S.C. §263a, that meet the requirements to perform Moderate, High or Waived Complexity Tests. This test is also 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.