ONLY AVAILABLE FOR SALES IN THE U.S.
De Novo FDA clearance with CLIA waiver for Point-of-Care settings
For use with Sofia 2 Analyzer
The next generation of COVID-19 rapid testing, Sofia 2 SARS Antigen+ Fluorescent Immunoassay (FIA), uses advanced immunofluorescence-based lateral flow technology in a sandwich design for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens. 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 testing is started within 6 days of symptom onset.
This test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the Sofia 2 SARS Antigen+ FIA and followed up with a molecular test.
Sofia 2 SARS Antigen+ FIA is the first FDA-cleared, 10-minute rapid antigen test for COVID-19.*
Sofia 2 SARS Antigen+ FIA will be available for healthcare professionals to purchase through authorized distributors soon. Contact your QuidelOrtho Account manager for more details.
Test kit (U.S. nasal swabs)
Catalog number: 20405
Kit size/Case size: 25/12
Where can I go for updates and more information?
CDC:
General Information - Coronavirus (COVID-19)
Laboratory Biosafety
FDA:
General Information - Coronavirus (COVID-19)
*Sofia 2 SARS Antigen+ FIA received De Novo FDA clearance on March 8, 2023 and CLIA waiver from the FDA on September 21, 2023.
ONLY AVAILABLE FOR SALES IN THE U.S.
De Novo FDA clearance with CLIA waiver for Point-of-Care settings
For use with Sofia 2 Analyzer
The next generation of COVID-19 rapid testing, Sofia 2 SARS Antigen+ Fluorescent Immunoassay (FIA), uses advanced immunofluorescence-based lateral flow technology in a sandwich design for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens. 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 testing is started within 6 days of symptom onset.
This test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the Sofia 2 SARS Antigen+ FIA and followed up with a molecular test.
Sofia 2 SARS Antigen+ FIA is the first FDA-cleared, 10-minute rapid antigen test for COVID-19.*
Sofia 2 SARS Antigen+ FIA will be available for healthcare professionals to purchase through authorized distributors soon. Contact your QuidelOrtho Account manager for more details.
Test kit (U.S. nasal swabs)
Catalog number: 20405
Kit size/Case size: 25/12
Where can I go for updates and more information?
CDC:
General Information - Coronavirus (COVID-19)
Laboratory Biosafety
FDA:
General Information - Coronavirus (COVID-19)
*Sofia 2 SARS Antigen+ FIA received De Novo FDA clearance on March 8, 2023 and CLIA waiver from the FDA on September 21, 2023.
Features & benefits
Rapid results in 10 minutes to support efficient dispositioning of patients.
Dual work modes adjust to your volume fluctuations. Allows for significant throughput and batching of samples in READ NOW Mode.
To access safety data sheets, package inserts, quick reference guides and all other technical and promotional materials, visit our technical documents library.
- Specifications
| Product specifications | |
| Time to results | 10 minutes |
| Sample type | Direct nasal swabs |
| Kit storage conditions | Room temperature (15°C to 35°C / 59°F to 86°F) |
| Controls | Positive and negative, included in kit |
| PPA (sensitivity) | 88.7% |
| NPA (specificity) | 99.3% |
| Shelf life | 24 months from date of manufacture |
| CLIA complexity | Waived |
