Fluorescent Immunoassay Analyzer Sofia® 2 CLIA Waived

Features

• Sofia 2 SARS Ag Starter Kit (Includes 1 leased Sofia 2 Instrument, Sofia SARS kit, Install Pack)
• The Sofia 2 SARS Antigen FIA test is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
• The Sofia 2 SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by their healthcare provider
• 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
• Testing 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 moderate, high or waived complexity tests
• The SARS Antigen FIA does not differentiate between SARS-CoV and SARS-CoV-2
• 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 positive results to the appropriate public health authorities
• Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management
• 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 SARS Antigen FIA is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings
• The Sofia 2 SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from SARS-CoV and SARS-CoV-2
• Sofia 2 is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet LED energy source
• Intuitive, fast and easy-to-use interface allows operators to quickly run patient samples or navigate stored data
• Results in 3-15 minutes (differs by assay)
• Excellent sensitivity and specificity compared to molecular and viral culture methods
• Includes Sofia SARS Ag Test 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, Positive Control Swab, Negative Control Swab, Package Insert, Quick Reference Instructions, QC Card

More Information

• Sofia 2 SARS Ag FDA EUA Letter
• Sofia 2 SARS Ag IFU
• Sofia 2 SARS Ag Healthcare Providers Fact Sheet
• Sofia 2 SARS Ag Patients Fact Sheet
• Sofia 2 Sales Sheet