

For use with Sofia 2 - FDA Emergency Use Authorization
The Sofia 2 Flu + SARS Antigen Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from influenza A and influenza B, and SARS-CoV-2. The Sofia 2 Flu + SARS Antigen FIA with the Sofia 2 analyzer provides automated and objective results in 15 minutes, allowing for testing of patients suspected of influenza A, influenza B, and COVID-19/2019-nCoV at the Point of Care.
Healthcare professionals can purchase the Sofia 2 Flu + SARS Antigen FIA through select authorized distributors.
Where can I go for updates and more information?
CDC:
General Information - Coronavirus (COVID-19)
Laboratory Biosafety
FDA:
General Information - Coronavirus (COVID-19)
Emergency Use Authorizations
Additional Information - Quidel's EUA COVID-19 Products (Scroll down to the list of EUA products and enter “Quidel” in the search box)
Features & Benefits
Feature | Benefit |
---|---|
One sample, three results | Time savings, material conservation, and patient comfort. |
Results in 15 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. |
Easy to use | Seamless test workflow follows a similar format to CLIA-waived Sofia and Sofia 2 assays. |
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 result. |
All necessary components included in kit | Ready for use with Sofia 2 for nasal or nasopharyngeal swab procedure. |
Self-contained Test Cassette | Clean, easy to use and dispose of. |
Product Specifications
Product Spec Name | Product Spec Data |
---|---|
Time to results | 15 minutes |
Sample type | Direct: Nasal swab, nasopharyngeal swab |
Kit storage conditions | Room temperature (15°C to 35°C / 59°F to 86°F) |
PPA (sensitivity) | Influenza A: NS - 90%, NPS - 97.1% Influenza B: NS - 89%, NPS - 90% SARS-CoV-2: 95.2% |
NPA (specificity) | Influenza A: NS - 95%, NPS - 94.6% Influenza B: NS - 96%, NPS - 97% SARS-CoV-2: 100% |
CLIA Complexity | Waived* |
Ordering Information
Catalog Number | Description | Kit Size / Case Size |
---|---|---|
20377 | Test Kit (US, Nasal Swab) | 25/12 |
20380 | Test Kit (XUS) | 25/12 |
Product Documentation
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