Sofia 2 SARS Antigen+ FIA received De Novo FDA clearance on March 8, 2023
Sofia 2 SARS Antigen+ Fluorescent Immunoassay (FIA), uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2
The Sofia 2 SARS Antigen+ FIA, with the Sofia 2 analyzer, provides automated and objective results in 10 minutes, allowing for COVID-19 testing of symptomatic patients when serial testing is started within 6 days of symptom onset
Sofia 2 SARS Antigen+ FIA is the first FDA-cleared, 10-minute rapid antigen test for COVID-19
Rapid results to support efficient dispositioning of patients
Reliable results without cross-reactivity to seasonal coronaviruses
Virena connection: Provides automated tracking, data capture, government reporting, and exclusive disease mapping
Ready for use with Sofia 2 for nasal swab procedure
Includes positive and negative controls
The test does not differentiate between SARS-CoV and SARS-CoV-2
A negative test result is presumptive, and it is recommended these results be confirmed by a molecular SARS-CoV-2 assay
Negative results do not preclude SARS-CoV-2 infections and should not be used as the sole basis for treatment or other patient management decisions
Positive results do not rule out co-infection with other respiratory pathogens
This test is intended for prescription use only and can be used in Point-of-Care settings
Materials Not Supplied in Kit: Timer or watch, Sofia 2 Instrument, Calibration Cassette
