One sample, three results mean time savings, material conservation, and patient comfort
Rapid results in 15 minutes to support efficient dispositioning of patients
Objective, accurate, reliable results without cross-reactivity to seasonal coronaviruses
Room temperature storage
The Sofia 2 Flu + SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with Sofia 2. Sofia 2 Flu + SARS Antigen FIA is intended for the simultaneous qualitative detection and differentiation of nucleocapsid protein antigen from SARS-CoV-2, influenza A, and influenza B directly from nasopharyngeal and nasal swab specimens collected from individuals who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between 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.
The test does not differentiate between SARS-CoV and SARS-CoV-2 viruses and is not intended to detect influenza C antigens.
All negative results are presumptive and should be confirmed with a FDA-cleared molecular assay. Negative results do not rule out SARS-CoV-2 or influenza virus infection and should not be used as the sole basis for treatment or patient management decisions.
The Sofia 2 Flu + SARS Antigen FIA is intended for use on the Sofia 2 only and by medical professionals or
trained operators who are proficient in performing tests using the Sofia 2 Instrument.
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.
For the State of California:
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 #
188-1-2377
Manufacturer #
20377
Brand
Sofia® 2
Manufacturer
Quidel
Country of Origin
United States
Application
Respiratory Test Kit
CLIA Complexity
CLIA Waived
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
Kit Storage Conditions
Room Temperature (15 °C to 35 °C / 59 °F to 86 °F)
Type
PPA (Sensitivity)
NPA (Specificity)
Influenza A
NS - 90%, NPS - 97.1%
NS - 95%, NPS - 94.6%
Influenza B
NS - 89%, NPS - 90%
NS - 96%, NPS - 97%
SARS-CoV-2
95.2%
100%
× Configurations
20377
Sofia® 2 Flu + SARS Antigen FIA Test Kit
20391
Sofia 2 Flu + SARS Antigen FIA Control Set
× Reagents and Materials Supplied - 20377 (25-Test Kit)
Individually Packaged Test Cassettes (25): Mouse monoclonal anti-influenza A and anti-influenza B antibodies; Monoclonal anti-SARS 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)
Flu + SARS Positive Control Swab (1): Swab is coated with non-infectious recombinant influenza A, influenza B, and SARS antigens
Negative Control Swab (1): Swab is coated with heat-inactivated, non-infectious Streptococcus C antigen
× Promotions are currently not available at this time. Please check back later.
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- 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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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. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A, and influenza B, 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.
The test has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories certified under the CLIA 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.
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