Sofia 2 SARS-Antigen Test Kit

In stock
SKU
QDL-20374

(25 Tests per Kit, Minimum Order of 4 Kits Required)

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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.

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.ama-assn.org/press-center/press-releases/ama-announces-cpt-code-antigen-tests-fight-against-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.

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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

87.5%

NPA

100%

Shelf life

12 months from date of manufacture

CLIA complexity

Moderate complexity*

*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.

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