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)
Catalog number: 20377 (U.S. nasal swab)
Kits/Case size: 25 kits per package, 12 packages per case.
Catalog number: 20380 (XUS)
Kits/Case size: 25 kits per package, 12 packages per case.
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)
Catalog number: 20377 (U.S. nasal swab)
Kits/Case size: 25 kits per package, 12 packages per case.
Catalog number: 20380 (XUS)
Kits/Case size: 25 kits per package, 12 packages per case.
Features & benefits
One sample, three results mean time savings, material conservation, and patient comfort.
Rapid results in 15 minutes to support efficient dispositioning of patients.
Objective, accurate, reliable results without cross-reactivity to seasonal coronaviruses.
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 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* |
*fda.gov: The settings in which an EUA-authorized test may be used are described in the Letter of Authorization. As discussed in the Guidance for Industry and Other Stakeholders: Emergency Use Authorization of Medical Products and Related Authorities, when the FDA authorizes tests for use at the point of care (including SARS-CoV-2 point of care test systems) under an EUA, such tests are deemed to be CLIA waived tests. Accordingly, for the duration of the emergency declaration, such tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Sofia® 2 Flu +SARS Antigen FIA training video
