Rally #188-1-2377
Quidel #20377
Respiratory Test Kit Sofia® 2 Flu + SARS Antigen FIA 25 Tests CLIA Waived
TEST KIT, SOFIA FLU & SARS ANTIGEN FIA ASSY (25/KT)
Features
- Accurate detection with direct samples
- Results in 15 minutes
- 12-month shelf life from date of manufacture
- All necessary components included in kit
For use on Sofia 2 analyzers ONLY - test cannot be run on a Sofia 1 analyzer; To be use only by medical professionals or trained operators who are proficient in performing tests using the Sofia 2 Instrument;
The test is intended for use in the simultaneous rapid in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus nucleocapsid protein antigen , but does not differentiate, between SARS-CoV and SARS-CoV-2 viruses and is not intended to detect influenza C antigens. The Sofia 2 Flu + SARS FIA is intended to be used with direct nasal or nasopharyngeal swabs and is not validated for use with viral transport media.
- Authorization -
Sofia 2 Flu + SARS Antigen FIA is for use under an FDA EUA: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorization.
Emergency use of this test 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 high, moderate or waived complexity tests.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
- Results -
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.
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. Negative SARS-CoV-2 results, from patients with symptom onset beyond five days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed.
Laboratories within the United States and its territories are required to report all SARS-CoV-2results to the appropriate public health authorities.
Product Specifications
| Manufacturer # | 20377 |
| Brand | Sofia® 2 |
| 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, Flu + SARS Positive Control Swab, Negative Control Swab, Package Insert, Quick Reference Instructions, QC Card |
| For Use With | For use with Sofia 2 Fluorescent Immunoassay Analyzer |
| Number of Tests | 25 Tests |
| Reading Type | Machine Read |
| Sample Type | Nasal Swab Sample |
| Specialty | Immunoassay |
| Test Format | Cassette Format |
| Test Kit Type | Rapid |
| Test Name | Flu + SARS Antigen FIA |
| Test Type | Fluorescence Immunoassay (FIA) |
| Time to Results | 15 Minute Results |
| UNSPSC Code | 41116144 |
| Shelf Life | 12-month from date of manufacture |
| Kit storage conditions | Room temperature (15 °C to 35 °C / 59 °F to 86 °F) |
| PPA (sensitivity) | Influenza A: NS - 90%, NPS - 97.1%, Influenza B: NS - 89%, NPS - 90%, SARS-CoV-2: 95.2% |
| NPA (specificity) | Influenza A: NS - 95%, NPS - 94.6%, Influenza B: NS - 96%, NPS - 97%, SARS-CoV-2: 100% |
More Information
- Sofia 2 Flu + SARS Antigen FDA EUA Letter
- SARS-CoV-2 Variant Detection Bulletin
- Quidel 12.28.21 Omicron Variant Letter
- CLSI - Sofia 2 Flu + SARS Antigen FIA
- FAQ - Sofia 2 Flu + SARS Antigen FIA
- HCP Fact Sheet - Sofia 2 Flu + SARS Antigen FIA
- Package Insert - Sofia 2 Flu + SARS Antigen FIA
- Package Insert - Sofia 2 Flu + SARS Antigen FIA Control Set
- Patient Fact Sheet - Sofia 2 Flu + SARS Antigen FIA
- Quick Reference Instructions - Sofia 2 Flu + SARS Antigen FIA
- Quiz - Sofia 2 Flu + SARS Antigen FIA
- SDS - Sofia 2 Flu + SARS Antigen FIA
- Sales Sheet - Sofia 2 Flu + SARS Antigen FIA
- Sample Collection - Sofia 2 Flu + SARS Antigen FIA
- Technical Bulletin - Firmware 1.12 Update
- Technical Bulletin - Sofia 2 Flu + SARS Antigen FIA (Liquid Proficiency Sample Testing Procedure)
- Training Tools - Sofia 2 Flu + SARS Antigen FIA
