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Sofia 2 Flu + SARS Antigen FIA
In stock
SKU
QDL-20377
(25 Tests per Kit)
Expected ship date is November 5th, please click Request a Quote to inquire about this product.
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.
If you experience any technical issues, such as machine errors or invalids, we recommend you reach out directly to Quidel's Technical Support line at https://www.quidel.com/support/support-request.
| 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
|
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.
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