Sofia 2 Flu + SARS Antigen FIA

SKU

QDL-20377

$595.00

(25 Tests per Kit)

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.

Ground shipping only available. If you need expedited shipping please contact us at 1.888.882.7739.

I ACKNOWLEDGE

Additional $6 Handling fee Per Item Added at Checkout

I ACKNOWLEDGE

Item is NOT for Resale and I must provide a valid CLIA License number in order to purchase the item.

Please provide your CLIA License Number - Valid CLIA licenses are 10 digits with letter "D" in third position (**D*******) MUST provide a valid CLIA number in order to ship item

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Details

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.

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.

All EUA authorized COVID-19 products are non-returnable with no exceptions unless damaged in transit, product is recalled for manufacturer performance issues or deemed defective by the manufacturer. Buyer should beware that EUA authorized products could be revoked by FDA and removed from authorization list. Products that are revoked are non-returnable and non-refundable. Note: Manufacturer recalls are returnable for replacement product only. No Cash refund will be given for manufacturer-initiated recall.

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