ONLY AVAILABLE FOR SALES IN THE U.S.
De Novo FDA clearance
For use with Sofia 2
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 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.*
Healthcare professionals can purchase the Sofia 2 SARS Antigen+ FIA through select authorized distributors. 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
ONLY AVAILABLE FOR SALES IN THE U.S.
De Novo FDA clearance
For use with Sofia 2
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 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.*
Healthcare professionals can purchase the Sofia 2 SARS Antigen+ FIA through select authorized distributors. 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
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.
One sample, three results for time savings and patient comfort.
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 | 15 minutes |
| Sample type | Fingerstick whole blood, venous whole blood, serum and plasma |
| Kit storage conditions | Room temperature (15°C to 35°C / 59°F to 86°F) |
| Controls | Positive and negative, included in kit |
| PPA (sensitivity) | 96.4% (fingerstick whole blood) |
| NPA (specificity) | 80.0% (fingerstick whole blood) 97.4% (serum/plasma) |
| Shelf life | 24 months |
