

For use with Sofia 2 and Sofia - FDA Emergency Use Authorization
The Sofia 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 SARS Antigen FIA, with the Sofia 2 and Sofia analyzers, provides automated and objective results in 15 minutes, allowing for COVID-19 testing of symptomatic patients within the first five days of symptoms and asymptomatic patients when tested serially.
Healthcare professionals can purchase the Sofia 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 |
---|---|
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 | Simple 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 read. |
All necessary components included in kit | Ready for use with Sofia 2 and Sofia 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 | 15 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 | 96.7% |
NPA | 100% |
CLIA complexity | Waived* |
Ordering Information
Catalog Number | Description | Kit Size / Case Size |
---|---|---|
20374 | Test Kit (US, Nasal Swabs) | 25/12 |
20378 | Test Kit (XUS) | 25/12 |
Product Documentation
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