Rally #188-1-2284
Quidel #20374
Respiratory Test Kit Sofia® SARS Antigen FIA 25 Tests CLIA Waived
TEST KIT, SOFIA 2 SARS ANTIGENFIA (25/KT)
Features
- Rapid COVID-19 testing
- Antigen-detecting assay
- Nasal swab tests included
- 15-minute results
- Compatible with the Sofia and Sofia 2 analyzers
- Objective, accurate results without cross-reactivity to seasonal coronaviruses.
- Self-contained Test Cassette that is clean, easy to use and dispose of.
- For in vitro diagnostic use; RX only.
- Authorization -
Sofia® SARS Antigen FIA test is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.
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.
- Results -
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.
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.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Product Specifications
| Manufacturer # | 20374 |
| Brand | Sofia® |
| Manufacturer | Quidel |
| Country of Origin | United States |
| Application | Respiratory Test Kit |
| 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 |
| For Use With | For use with Sofia / Sofia 2 Instrument |
| Number of Tests | 25 Tests |
| 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 |
| UNSPSC Code | 41116205 |
| 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% |
More Information
- CLSI - Sofia SARS Antigen FIA
- FAQ - Sofia SARS Antigen FIA
- HCP Fact Sheet - Sofia SARS Antigen FIA
- Package Insert - Sofia SARS Antigen FIA (EUA)
- Patient Fact Sheet - Sofia SARS Antigen FIA
- Quick Reference Instructions - Batch Testing Protocol
- Quick Reference Instructions - Sofia SARS Antigen FIA
- SDS - Sofia SARS Antigen FIA
- Sales Sheet - Sofia SARS Antigen FIA
- Technical Bulletin - Antigen CPT Code
- Technical Bulletin - Antigen vs. Antibody Testing
- Technical Bulletin - Detection of SARS-CoV-2 and SARS-CoV
- Technical Bulletin - Liquid Proficiency Sample Testing Procedure
- Technical Bulletin - SARS-CoV-2 Virus Inactivation
- Sofia SARS 2 Antigen FIA FDA EUA Letter
- Sofia SARS Antigen FDA EUA June 9 Addendum
- Quidel 12.28.21 Omicron Variant Letter
- Sofia SARS Antigen Firmware Notification Letter
