Rally #188-1-2284
Quidel #20374
Sofia® SARS Antigen FIA (25 Test/KT 12 KT/CS)
Respiratory Test Kit, SARS-CoV-2, Lateral Flow Immunofluorescent Sandwich Assay, Anterior Nasal Swab, Rx Only, CLIA Complexity Waived
Features
- Accurate detection with direct samples
- Rapid results in 15 minutes
- All necessary components included in kit are ready for use with Sofia 2 and Sofia for nasal swab procedure
- Room temperature storage
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 Sofia SARS Antigen FIA does not differentiate between SARS-CoV and SARS-CoV-2.
All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions.
The Sofia SARS Antigen FIA is intended for use by medical professionals or operators who are proficient in performing tests in a point of care setting.
Important Note:
- Product is non-returnable; please make sure it is the right product before ordering.
- If put into refrigeration, do not freeze.
- For in vitro diagnostic use.
- Rx Only.
- For use under an Emergency Use Authorization (EUA) only.
- For more information on this product's EUA, please go to the EUA section below.
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.
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| Rally # | 188-1-2284 |
| Manufacturer # | 20374 |
| Brand | Sofia® |
| Manufacturer | Quidel |
| Country of Origin | United States |
| Application | Respiratory Test Kit |
| CLIA Complexity | CLIA Waived |
| For Use With | For use with Sofia / Sofia 2 Instrument |
| Number of Tests | 25 Tests |
| Reading Type | Machine Read |
| Sample Type | Direct Nasal Swabs |
| Specialty | Immunoassay |
| Technology | Lateral Flow 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% |
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Currently Unavailable
Currently Unavailable
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Reagents and Materials Supplied - 20374 (25-Test Kit)
Reagents and Materials Supplied - 20374 (25-Test Kit)
- Individually Packaged Test Cassettes (25): Monoclonal anti-SARS antibodies
- Reagent Tubes (25): Lyophilized buffer with detergents and reducing agents
- Reagent Solution (25): Ampoules with salt solution
- Sterile Nasal Swabs (Kits #20374) (25)
- Small, Clear 120 µL Fixed Volume Pipettes (25)
- SARS Positive Control Swab (1): Swab is coated with non-infectious recombinant SARS 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)
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Manufacturer Documentations
Manufacturer Documentations
- 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
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Promotions are currently not available at this time. Please check back later.
Promotions are currently not available at this time. Please check back later.
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You can find more informations on reimbursement details here.
- 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, QuidelOrtho. 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.
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The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
EUA - Emergency Use Authorization
In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories; use by laboratories certified under the CLIA that meet the requirements to perform moderate, high or waived complexity tests. This product 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. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
