Respiratory Test Kit Sofia® 2 Flu + SARS Antigen FIA 25 Tests CLIA Waived

Features

• 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-authorizations
• Starter Kit: (1) Leased Sofia 2 Analyzer, (1) Install Pack, (1) Sofia Flu + SARS Kit
• 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 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 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
• 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
• 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
• 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
• Laboratories within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities
• 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
• 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
• 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; the Sofia 2 Flu + SARS Antigen FIA test is only for use under the Food and Drug Administration’s Emergency Use Authorization
• Results in 15 minutes
• Accurate detection with direct samples
• Installation Pack Sofia® 2 Includes: QuickStart Guide, Calibration Cassette, Adendum For Sofia 2 Analyzer
• Sofia Flu + SARS kit includes: (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
• Room temperature storage
• 12-month shelf life from date of manufacture

More Information

• Sofia 2 Flu + SARS Antigen FDA EUA Letter
• Sofia 2 Flu + SARS Antigen IFU
• Sofia 2 Flu + SARS Antigen Patients Fact Sheet
• Sofia 2 Flu + SARS Antigen Healthcare Providers Fact Sheet
• Sofia 2 Flu + SARS Antigen Sales Sheet