Immunoassay Analyzer Starter Kit Sofia® 2

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