Quidel Sofia® SARS Antigen FIA
The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly or after the swabs have been added to either Copan UTM or the CDC’s formulation of VTM from individuals who are suspected of COVID-19 by their healthcare provider. 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.
Specimen type: nasopharyngeal (NP) and nasal (NS) swab specimens
Turnaround time: 15 minutes
CLIA complexity: Waived, Moderate, or High
Ordering information:
Contact your Cardinal Health Laboratory Products Representative to order or complete the form below.
| Material # | Description | Pkg string | Shipping UOM |
|---|---|---|---|
| 20374 | Sofia SARS Antigen FIA (25 test/kt) | 12 kt/cs* | KT/CS |
| 20383 | Sofia SARS CoV-2 NP Swab 25/KT (25 test/kt) | 12 kt/cs* | KT/CS |
*Minimum order: 1 KT
Related information
Product insert
Fact sheet for patients
Fact sheet for healthcare providers
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