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.*
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.
Where can I go for updates and more information?
CDC:
General Information - Coronavirus (COVID-19)
Laboratory Biosafety
FDA:
General Information - Coronavirus (COVID-19)
Features & Benefits
| Feature | Benefit |
|---|---|
Results in 10 minutes | Rapid results to support efficient dispositioning of patients. |
Objective, accurate results | Reliable results without cross-reactivity to seasonal coronaviruses. |
Dual work modes | Adjusts to your volume fluctuations. Allows for significant throughput and batching of samples in READ NOW Mode. |
Virena connection | Provides automated tracking, data capture, government reporting, and exclusive disease mapping. |
Fluorescent technology with automated read | Objective result that eliminates the subjectivity of a visual read. |
All necessary components included in kit | Ready for use with Sofia 2 for nasal swab procedure. |
Self-contained Test Cassette | Clean, easy to use and dispose of. |
Product Specifications
| Product Spec Name | Product Spec Data |
|---|---|
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 | 89.0% |
NPA | 99.6% |
CLIA complexity | Waived |
Ordering Information
| Catalog Number | Description | Kit Size / Case Size |
|---|---|---|
20405 | Test Kit (US, Nasal Swabs) | 25/12 |
Product Documentation
