Respiratory Test Kit Sofia® SARS Antigen FIA 25 Tests CLIA Waived (M-1166253)

Name: TEST KIT, SOFIA 2 SARS ANTIGENFIA (25TESTS/KT 12KT/CS) • Sofia® SARS Antigen FIA test is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations • 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 • Product ships with minimum 60 days dating • 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 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; the agent detected may not be the definite cause of disease • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities • 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 • Rapid results in 15 minutes to support efficient dispositioning of patients • Objective, accurate results without cross-reactivity to seasonal coronaviruses • The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument • Seamless test workflow follows a similar format to CLIA-waived Sofia and Sofia 2 assays • Dual work modes adjust to volume fluctuations and allows for significant throughput and batching of samples in READ NOW Mode • Fluorescent technology with automated read eliminates the subjectivity of a visual result • Virena provides automated tracking, data capture, government reporting, and exclusive disease mapping • All necessary components included in kit, ready for use for nasal swab procedure • Self-contained Test Cassette that is clean, easy to use and dispose of • For in vitro diagnostic use; RX only