Rally #188-1-2028
Quidel #20218
Respiratory Test Kit Sofia® Influenza A+B FIA Influenza A + B 25 Tests CLIA Waived Sample Dependent
TEST KIT, INFLUENZA A&B SOFIA (25/KT)
Featur
- Requires Sofia or Sofia2 Analyzer (not included) - please see 1058938 and 1087517
- The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients
- All components included in the kit
- Compatible with RSV Extraction Reagent means when testing with Sofia Influenza A+B FIA, a single patient sample may also be used to test with Sofia RSV FIA
- Fixed volume pipette collects and dispenses correct amount of sample needed for testing
- Room temperature storage
- Product should be kept in temperature between 59 to 86 degrees
The Sofia Influenza A+B Fluorescent Immunoassay (FIA) uses advanced immunofluorescence–based lateral–flow technology to detect influenza A and influenza B viral nucleoprotein antigens. It is for use with Sofia® 2 and Sofia® Analyzers. When Sofia 2 is use with Advance Result Technology (ART), it delivers accurate, objective and automated test results in as few as three minutes.
Product Specifications
| Manufacturer # | 20218 |
| Brand | Sofia® Influenza A+B FIA |
| Manufacturer | Quidel |
| Country of Origin | United States |
| Application | Respiratory Test Kit |
| CLIA Classification | CLIA Waived for Direct Nasal Swab, Nasopharyngeal Swab, Nasopharyngeal Aspirate Samples / CLIA Moderate Complexity for Nasopharyngeal Swab, Nasopharyngeal Aspirate Samples Eluted in Transport Media |
| CLIA Classified | CLIA Waived Sample Dependent |
| Contents 1 | (25) Test Cassettes, (25) Reagent Tubes, (25) Reagent Solution, (25) Nasal Swabs, (25) Large Pipettes, (25) Small Pipettes, Positive Control Swab, Negative Control Swab, Printer Paper, Package Insert |
| For Use With | For Sofia® or Sofia 2® Flourescent Immunoassay Analyzer |
| Number of Tests | 25 Tests |
| Reading Type | Machine Read |
| Sample Type | Nasal Swab / Nasopharyngeal Swab / Nasal Wash / Nasal Aspirate Sample |
| Specialty | Immunoassay |
| Test Format | Cassette Format |
| Test Kit Type | Rapid |
| Test Name | Influenza A + B |
| Test Type | Fluorescence Immunoassay (FIA) |
| Time to Results | 3 to 15 Minute Results |
| UNSPSC Code | 41116144 |
| Controls | Positive and negative |
| Nasal swab sensitivity | A: 90%, B: 89% |
| Nasopharyngeal swab sensitivity | A: 97%, B: 90% |
| Nasopharyngeal aspirate/wash sensitivity | A: 99%, B: 88% |
| Nasal swab specificity | A: 95%, B: 96% |
| Nasopharyngeal swab specificity | A: 95%, B: 97% |
| Nasopharyngeal aspirate/wash specificity | A: 96%, B: 96% |
| Shelf life | 24 months from date of manufacture |
| Transport Media Compatibility | Copan Universal Transport Media, Hank’s Balanced Salt Solution, M4, M4–RT, M5, M6, Modified Liquid Stuarts, Saline, Starplex Multitrans |
More Information
- CLSI - Sofia Influenza A+B FIA
- FAQ - Sofia Influenza A+B FIA
- Package Insert - Sofia Influenza A+B FIA
- Quick Reference Instructions - Sofia Influenza A+B FIA
- SDS - Sofia Influenza A+B FIA
- Sales Sheet - Sofia Influenza A+B FIA
- Sample Collection - Sofia Influenza A+B FIA
- Technical Bulletin - 2021 CDC Human Influenza Virus Panel - Aspirate (Sofia 2)
- Technical Bulletin - 2021 CDC Human Influenza Virus Panel - Aspirate (Sofia)
- Technical Bulletin - 2021 CDC Human Influenza Virus Panel - Swab (Sofia 2)
- Technical Bulletin - 2021 CDC Human Influenza Virus Panel - Swab (Sofia)
- Technical Bulletin - Compatible Swabs
- Technical Bulletin - FluMist
- Technical Bulletin - New Blue Color
- Technical Bulletin - Test for Both Influenza and RSV With One Patient Sample
- Technical Bulletin - Transport Media
