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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.

Features & Benefits

FeatureBenefit

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 NameProduct 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%
Shelf life

12 months from date of manufacture

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.

Ordering Information

Catalog NumberDescriptionKit Size / Case Size
20377

Test Kit (US, Nasal Swab)

25/12
20380

Test Kit (XUS)

25/12
20390

Test Kit (US, Nasopharyngeal Swab)

25/12
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