Rapid Test Kit Sofia® Fluorescence Immunoassay (FIA) SARS Antigen FIA Nasal Swab / Nasopharyngeal Swab Sample 25 Tests

Features

• 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 Product ships with minimum 30 days dating 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 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