Sofia SARS-Antigen Test Kit
(25 Tests per Kit, Minimum Order of 4 Kits Required)
For use with Sofia 2 and Sofia - FDA Emergency Use Authorization
The Sofia SARS Antigen Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2. The Sofia SARS Antigen FIA, with the Sofia 2 and Sofia analyzers, provides automated and objective results in 15 minutes, allowing for testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments.
CLIA complexity: Waived*
CPT 87426
Descriptor: Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19])
https://www.quidel.com/reimbursement-codes
NOTE: The reimbursement amount is still to be determined by CMS.
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 |
|---|---|
|
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 |
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. |
Product Specifications
|
Time to results
|
15 minutes |
|
Sample Type
|
Direct or VTM: Nasal swab, nasopharyngeal swab |
|
Kit storage conditions
|
Room temperature (15°C to 35°C / 59°F to 86°F) |
|
Controls
|
Positive and negative, included in kit |
|
PPA
|
96.7% |
|
NPA
|
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.
