Quidel Rapid Test Kit Sofia® Fluorescence Immunoassay (FIA) SARS Antigen FIA Nasal Swab / Nasopharyngeal Swab Sample 25 Tests- 20374

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

• 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

Specifications :

Contents 1: (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
For Use With: For use with Sofia / Sofia 2 Instrument
Number of Tests: 25 Tests
Product Dating: McKesson Acceptable Dating: we will ship >= 30 days
Reading Type: Machine Read
Sample Type: Nasal Swab / Nasopharyngeal Swab Sample
Technology: Immunofluorescent Sandwich Assay
Test Format: Cassette Format
Test Name: SARS Antigen FIA
Test Type: Fluorescence Immunoassay (FIA)
Time to Results: 15 Minute Results