Description
- Sofia SARS Antigen FIA test is only for use under the Food and Drug Administration’s Emergency Use Authorization:
- 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
- Product ships with minimum 60 days dating
- 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 SARS Antigen FIA does not differentiate between SARS-CoV and SARS-CoV-2
- 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 positive results to the appropriate public health authorities
- Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
- Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19
- Rapid results in 15 minutes to support efficient dispositioning of patients
- Objective, accurate results without cross-reactivity to seasonal coronaviruses
- The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument
- Seamless test workflow follows a similar format to CLIA-waived Sofia and Sofia 2 assays
- Dual work modes adjust to volume fluctuations and allows for significant throughput and batching of samples in READ NOW Mode
- Fluorescent technology with automated read eliminates the subjectivity of a visual result
- Virena provides automated tracking, data capture, government reporting, and exclusive disease mapping
- All necessary components included in kit, ready for use for nasal swab procedure
- Self-contained Test Cassette that is clean, easy to use and dispose of
- For in vitro diagnostic use; RX only
Product Specs
| Item Number | 1166253 |
|---|---|
| Catalog Number | 20374 |
| UOM | CS |
| Level 1 Family Description | Lab-Waived Lab |
| Level 2 Category Description | Lab-Respiratory Testing |
| Level 3 Group Description | COVID Testing |
| Level 4 Sub-Category Description | COVID - Reader Read |
| Application | Respiratory Test Kit |
| Brand | Sofia |
| Buy American Act (BAA) Compliant | Yes |
| CLIA Classification | CLIA Waived |
| CLIA Classified | CLIA Waived |
| Contents 1 | (25) Individually Packaged Test Cassettes, (25) Reagent Tubes, (25) Ampoules of Reagent Solution, (25) Sterile Nasal Swabs, (25) X 120 µL Fixed Volume Pipettes, Positive Control Swab, Negative Control Swab, Package Insert, Quick Reference Instructions, QC Card |
| Country of Origin | United States |
| For Use With | For use with Sofia / Sofia 2 Instrument |
| Is_ECAT | N |
| Is_GSA | Y |
| Is_VA | N |
| Manufacturer | Quidel |
| Manufacturer # | 20374 |
| McKesson # | 1166253 |
| Number of Tests | 25 Tests |
| Purchase Program Type | Standard Purchase |
| Reading Type | Machine Read |
| Sample Type | Nasal Swab / Nasopharyngeal Swab Sample |
| Specialty | Immunoassay |
| Technology | Immunofluorescent Sandwich Assay |
| Test Format | Cassette Format |
| Test Kit Type | Rapid |
| Test Name | SARS Antigen FIA |
| Test Type | Fluorescence Immunoassay (FIA) |
| Time to Results | 15 Minute Results |
| Trade Agreement Act (TAA) Compliant | Yes |
| UNSPSC Code | 41116205 |