Rally #188-1-2028
Quidel #20218
Sofia® Influenza A+B FIA (25 Test/KT 12 KT/CS)
Respiratory Test Kit, Influenza A+B, Rapid, Fluorescent Immunoassay, Nasal Swab / Nasopharyngeal Swab / Nasal Wash / Nasal Aspirate, Rx Only, CLIA Complexity Waived
Quidel Sofia 2 Influenza A+B FIA Starter Kit Available
Bundle Offer Valid Through December 31, 2025See Details On 188-1-2310
- CLIA waived for nasal and nasopharyngeal swabs, nasal aspirate and wash
- Single specimen may be used for both Sofia RSV and Sofia Influenza
- Can be use with Sofia or Sofia 2 and is compatible with viral transport media
- Fixed–volume pipette collects and dispenses correct amount of sample needed for testing
CLIA Complexity: Waived for direct nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens
CLIA Complexity: Moderate for nasopharyngeal swab and nasopharyngeal aspirate/wash specimens eluted in transport media
A Certificate of Waiver is required to perform this test in a CLIA waived setting. To obtain a Certificate of Waiver, please contact your state health department.
Important Note:
- Product is non-returnable; please verify your ordering information before purchasing.
- If put into refrigeration, do not freeze.
- For professional in vitro diagnostic use.
- Rx Only
Warning: This product can expose you to chemicals known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.
Rally # | 188-1-2028 |
Manufacturer # | 20218 |
Brand | Sofia® Influenza A+B FIA |
Manufacturer | Quidel |
Country of Origin | United States |
Application | Respiratory Test Kit |
CLIA Complexity |
|
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 | Sofia 2: Positive Result in as few as 3 minutes, Negative Result 15 minutes Sofia: 15 minutes |
UNSPSC Code | 41116144 |
Controls | Positive and Negative |
Shelf life | 24 months from date of manufacture |
Kit Storage Condition | Room Temperature (15°C to 30°C / 59°F to 86°F) |
Transport Media Compatibility | Copan Universal Transport Media, Hank’s Balanced Salt Solution, M4, M4–RT, M5, M6, Modified Liquid Stuarts, Saline, Starplex Multitrans |
Sample Type | Sensitivity | Specificity |
Nasal Swab | A: 90%, B: 89% | A: 95%, B: 96% |
Nasopharyngeal Swab | A: 97%, B: 90% | A: 95%, B: 97% |
Nasopharyngeal Aspirate/Wash | A: 99%, B: 88% | A: 96%, B: 96% |
A - Influenza A
B - Influenza B
Refer to Package Insert for additional and more detailed performance claims.
Currently Unavailable
Reagents and Materials Supplied - 20218 (25-Test Kit)
- Individually Packaged Test Cassettes (25): Mouse monoclonal anti-influenza A and anti-influenza B antibodies
- Reagent Tubes (25): Lyophilized buffer with detergents and reducing agents
- Reagent Solution (25): Ampoules with salt solution
- Sterile Nasal Swabs (25)
- Small, Clear 120 µL Fixed Volume Pipettes (25)
- Large, Pink 250 µL Fixed Volume Pipettes (25)
- Influenza A and Influenza B Positive Control Swab (1): Swab is coated with non-infectious recombinant influenza A and influenza B antigens
- Negative Control Swab (1): Swab is coated with heat-inactivated, non-infectious Streptococcus C antigen
- Package Insert (1)
- Quick Reference Instructions (1)
- QC Card (located on kit box)
- Printer Paper (1)
Documentation Links
General Documentations
- 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
- Reimbursements Information -
This product maybe reimbursable, depending on various factors including current law and policies. Rally Inc. does not handle these reimbursements; instead, each reimbursement is handled solely between you, the customer, and the manufacturer, Quidel. Rally Inc. does not oversee these reimbursements. To check eligibility and get your reimbursements, please follow the manufacturer's reimbursements instructions.You can find more informations on reimbursement details here.