The Sofia Influenza A+B FIA is an immunofluorescence-based test designed to detect influenza A and influenza B viral nucleoprotein antigens in direct nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens, as well as in transport media from symptomatic patients. This qualitative test aids in the rapid differential diagnosis of acute influenza A and B viral infections and is intended for professional and laboratory use. It does not detect influenza C antigens. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not rule out influenza virus infections and should not be the sole basis for treatment or patient management decisions.

The Sofia Influenza A+B FIA can be used with Sofia or Sofia 2 analyzers. Performance characteristics for influenza A and B were established during February through March 2011 when specific strains were predominant, but performance may vary with other emerging influenza viruses. If infection with a novel influenza virus is suspected, specimens should be collected following appropriate infection control precautions and sent to state or local health departments for testing. Viral culture should only be performed in BSL 3+ facilities.

Features:

• Fixed-volume pipette ensures the correct amount of sample is collected and dispensed.
• CLIA waived for nasal and nasopharyngeal swabs, nasal aspirate, and wash specimens, facilitating easy-to-perform testing.
• Compatible with RSV extraction reagent, allowing a single sample to be used for both Sofia Influenza A+B and Sofia RSV tests.

Kits Include:

• (25) Test Cassettes
• (25) Reagent Tubes
• (25) Reagent Solution
• (25) Nasal Swabs
• (25) Large Pipettes
• (25) Small Pipettes
• (1) Positive Control Swab
• (1) Negative Control Swab
• (1) Printer Paper
• (1) Package Insert

Warnings and Precautions:

• For in vitro diagnostic use.
• Do not use the kit contents beyond the expiration date printed on the outside of the box.
• Use appropriate precautions in the collection, handling, storage, and disposal of patient samples and used kit contents.
• Use of Nitrile, Latex (or equivalent) gloves is recommended when handling patient samples.
• Do not reuse the used Test Cassette, Fixed Volume Pipettes, Reagent Tubes, solutions, or Control Swabs.
• The user should never open the foil pouch of the Test Cassette exposing it to the ambient environment until the Test Cassette is ready for immediate use.
• Discard and do not use any damaged or dropped Test Cassette or material.
• The Reagent Solution contains a salt solution (saline). If the solution contacts the skin or eye, flush with copious amounts of water.
• To obtain accurate results, the Package Insert instructions must be followed.
• The Calibration Cassette must be kept in the provided storage pouch between uses.
• Inadequate or inappropriate sample collection, storage, and transport may yield false test results.
• Sample collection and handling procedures require specific training and guidance.
• To obtain accurate results, use the Viral Transport Media (VTM) recommended in this Package Insert.
• When collecting a nasal swab sample, use the Nasal Swab supplied in the kit.
• When collecting a nasopharyngeal swab sample, use a nylon flocked nasopharyngeal swab.
• Use the appropriate Fixed Volume Pipette in accordance with test procedures:
  • Only the Small, Clear 120 μL Fixed Volume Pipette is to be used for adding patient sample to the Test Cassette for all sample types.
  • Only the Large, Pink 250 μL Fixed Volume Pipette is to be used with the aspirate/wash or viral transport media test procedure when transferring the patient sample from the collection cup into the Reagent Tube.
• Do not pour sample from the Reagent Tube into the Test Cassette sample well. Use the provided Small, Clear 120 μL Fixed Volume Pipette when adding the sample to the Test Cassette.
• To obtain accurate results, do not use visually bloody or overly viscous samples.
• Do not write on the barcode of the Test Cassette. This is used by Sofia and Sofia 2 to identify the type of test being run and to identify the individual Test Cassette so as to prevent a second read of the Test Cassette by the same Sofia or Sofia.
• If infection with a novel influenza A virus is suspected, based on current clinical and epidemiological screening criteria recommended by public health authorities, samples should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture samples.
• Although this test has been shown to detect cultured avian influenza viruses, including avian Influenza A subtype H5N1 virus, the performance characteristics of this test with samples from humans infected with H5N1 or other avian influenza viruses are unknown.
• As the detection reagent is a fluorescent compound, no visible results will form on the test strip. Sofia or Sofia 2 must be used for result interpretation.
• To obtain accurate results, an opened and exposed Test Cassette should not be used inside a laminar flow hood or in a heavily ventilated area.
• Testing should be performed in an area with adequate ventilation.
• Dispose of containers and unused contents in accordance with Federal, State, and Local regulatory requirements.
• Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this kit.
• Wash hands thoroughly after handling.

Storage:

Store the kit at room temperature, 59°F to 86°F (15°C to 30°C), out of direct sunlight. Kit contents are stable until the expiration date printed on the outer box. Do not freeze.