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.
Test kit (US, Nasal swab)
Catalog number: 20374
Kit size/Case size: 25/12
Test kit (XUS)
Catalog number: 20378
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)
Emergency Use Authorizations
Additional Information - QuidelOrtho's EUA COVID-19 Products (Scroll down to the list of EUA products and enter “QuidelOrtho” in the search box)
The Sofia® SARS Antigen FIA has not been FDA cleared or approved but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner.
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.
Test kit (US, Nasal swab)
Catalog number: 20374
Kit size/Case size: 25/12
Test kit (XUS)
Catalog number: 20378
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)
Emergency Use Authorizations
Additional Information - QuidelOrtho's EUA COVID-19 Products (Scroll down to the list of EUA products and enter “QuidelOrtho” in the search box)
The Sofia® SARS Antigen FIA has not been FDA cleared or approved but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner.
Features & benefits
Rapid results in 15 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.
All necessary components included in kit are ready for use with Sofia 2 and Sofia for nasal swab procedure.
To access safety data sheets, package inserts, quick reference guides and all other technical and promotional materials, visit our technical documents library.
- Specifications
- Learning hub
| Product specifications | |
| 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* |
Sofia SARS Antigen FIA training video
Sofia SARS Antigen FIA batch testing protocol
