Test Kits

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

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  • 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
More Information
Country Of OriginUnknown
Manufacturer Number20374
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