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Quidel Sofia Influenza A+B Quick Reference Instructions

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Study the Package Insert and User Manual
thoroughly before using Quick Reference
Instructions. This is not a complete
Package Insert.
Test Procedure
NOTE: The procedures for testing swab specimens versus liquid specimens in viral transport media are different. Read carefully.
All specimens must be at room temperature before testing.
Expiration date: Check expiration date on each individual test package or outer box before using. Do not use any test past the expiration date on the label.
Swab Test Procedure (Nasal/Nasopharyngeal)
Verify that Sofia or
Dispense all of the Reagent
Sofia 2 is set to the
Solution into the Reagent
desired Mode:
Tube. Swirl the Reagent Tube
WALK AWAY or
to dissolve its contents.
READ NOW. See
the "Using Sofia" or
"Using Sofia 2"
section for more
information.
CLIA Complexity: Waived for direct nasal swab, nasopharyngeal
swab and nasopharyngeal aspirate/wash specimens
CLIA Complexity: Moderate for nasopharyngeal swab and
nasopharyngeal aspirate/wash specimens eluted in
transport media
Place the patient swab
Roll the Swab head
sample into the Reagent
against the inside of the
Tube. Roll the swab at
Reagent Tube as you
least 3 times while
remove it. Dispose of
pressing the head
the used Swab in your
against the bottom and
biohazard waste.
side of the Reagent
Tube.

QUICK REFERENCE

For use with Sofia and Sofia 2.
IMPORTANT! Read instructions carefully before
beginning. The test procedure below is unique to the
Sofia Influenza A+B FIA and may differ from other Sofia
FIA procedures.
Fill the provided Small, Clear
Firmly squeeze the top bulb to
empty the contents of the Small,
120 µL Fixed Volume Pipette with
Clear 120 µL Fixed Volume Pipette
patient sample from the Reagent
into the Test Cassette sample well.
Tube.
Extra liquid in the overflow bulb is
To fill the Fixed Volume Pipette
OK.
NOTE: The Fixed Volume Pipette is
with the patient sample:
designed to collect and dispense the
a) FIRMLY squeeze the top bulb.
correct amount of patient sample.
b) Still squeezing, place the Pipette
Discard the Pipette in your
tip into the sample.
biohazard waste.
c) With the Pipette tip still in the
NOTE: Do not pour sample from the
Reagent Tube. Use the provided
sample, release pressure on bulb
Small, Clear 120 µL Fixed Volume
to fill the Pipette.
Pipette.
120 µL Pipette
INSTRUCTIONS
Rx only
Proceed to the
"Using Sofia" or
"Using Sofia 2"
section to complete
the test.

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Summary of Contents for Quidel Sofia Influenza A+B

  • Page 1: Quick Reference

    The test procedure below is unique to the Instructions. This is not a complete Sofia Influenza A+B FIA and may differ from other Sofia Package Insert. CLIA Complexity: Moderate for nasopharyngeal swab and FIA procedures.
  • Page 2 Liquid Specimens Test Procedure Verify that Sofia or Dispense all of the Reagent Fill the provided Large, Pink Firmly squeeze the top bulb to Fill the provided Small, Firmly squeeze the top bulb Proceed to the Sofia 2 is set to the Solution into the Reagent 250 µL Fixed Volume Pipette empty the contents of the...
  • Page 3 Using Sofia WALK AWAY/READ NOW Modes Refer to the Sofia User Manual. Sofia may be set to two different modes (WALK AWAY and READ NOW). The procedures for each mode are described below. WALK AWAY Mode READ NOW Mode In WALK AWAY Mode, the user immediately inserts the Test Cassette into Sofia. Allow the test to develop for the FULL 15 minutes BEFORE placing it into Sofia.
  • Page 4 Sofia Interpretation of Results When the test is complete, the results will be displayed on the Sofia screen. The results can be Reader Display Interpretation automatically printed on the integrated printer if this option is selected. Test Lines will not be Flu A: Positive Positive Test for Flu A visible to the naked eye.
  • Page 5 Using Sofia 2 WALK AWAY/READ NOW Modes Refer to the Sofia 2 User Manual. Sofia 2 may be set to two different modes (WALK AWAY and READ NOW). The procedures for each mode are described below. WALK AWAY Mode READ NOW Mode In WALK AWAY Mode, the user immediately inserts the Test Cassette into Sofia Allow the test to develop for the FULL 15 minutes BEFORE placing it into Sofia 2.
  • Page 6 FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other patient management decisions. The Sofia Influenza A+B FIA may be used with Sofia or Sofia 2.