Learn About Quidel Sofia SARS Antigen Test FIA (POC)
This product is indicated for use with Sofia 2 and Sofia instruments for nasal swab procedure.
The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia, Sofia 2, and Sofia Q instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The Sofia SARS Antigen FIA does not differentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.
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.
How does the assay work?
The test employs immunofluorescence technology used with Sofia and Sofia 2 to detect nucleocapsid protein from
SARS-CoV and SARS-CoV-2 virus in nasopharyngeal (NPS) and nasal swab (NS) specimens.
Does the test come with everything needed to perform the assay?
The test comes with all the materials necessary to perform the test with nasal swab specimens, except for the Sofia
or Sofia 2 instrument.
Where is the test performed?
Testing is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate complexity/high complexity tests, or at the Point of Care (POC) in patient care settings operating under a CLIA Certificate of Waiver.
- Package Insert - EUA
- Frequently Asked Questions
- Safety Data Sheet
- Quick Reference Instructions
- Patient Fact Sheet
- Healthcare Provider Fact Sheet
Quidel Sofia SARS Antigen Test FIA (POC) Features:
- Results in 15 minutes
- 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 - Simple 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 read.
- All necessary components included in kit -
Ready for use with Sofia 2 and Sofia for nasal swab procedure.
- Self-contained Test Cassette - Clean, easy to use and dispose of.
|Quantity||Box or Case|
|For Use With||Sofia / Sofia 2 Instrument|
|Reading Type||Machine Read|
|Sample Type||Nasal Swab|
|Technology||Immunofluorescent Sandwich Assay|
|Test Format||Cassette Format|
|Test Type||Fluorescence Immunoassay (FIA)|
|Time To Results||15 minutes|
Shipping, Payment, & Returns
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30-day return policy.
You can request a return up to 30 days after receiving your item. To be eligible for a return, your item must be in the same condition that you received it, unworn or unused, with tags, and in its original packaging. You’ll also need the receipt or proof of purchase.
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