Reader Display
Interpretation
Flu A:
Flu B:
Procedural Control:
Positive Test for Flu A
(influenza A antigen present)
Flu A:
Flu B:
Procedural Control:
Positive Test for Flu B
(influenza B antigen present)
Flu A:
Flu B:
Procedural Control:
Positive Test for both Flu A and Flu B
(influenza A and B antigen present)
Flu A:
Flu B:
Procedural Control:
Negative Test for Flu A and Flu B
(no antigen detected)
Flu A:
Flu B:
Procedural Control:
Result Invalid
From the main menu,
select Run QC.
Follow the prompts on the screen. Scan the QC Card (located on the kit box).
Sofia 2 prompts the user to select the desired mode (WALK AWAY or READ NOW).
Run the External Control Swabs.
Follow the Swab Test procedure of this Quick Reference Instructions. First test the
Positive Swab, followed by the Negative Swab.
After both the Positive and Negative Swabs have been run, the results will be displayed as
or
.
INTENDED USE
The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in direct nasal swab, nasopharyngeal swab, and nasopharyngeal
aspirate/wash specimens and nasopharyngeal swab and nasopharyngeal aspirate/wash specimen in transport media from symptomatic patients. This qualitative test is intended for use
as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive and it
is recommended these results be confirmed by viral culture or an 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.
ASSISTANCE
If Sofia, Sofia 2 or the assay do not perform as expected, contact Quidel Technical Support 800.874.1517 (in the U.S.), 858.552.1100 (outside the U.S.), [email protected], or
your local distributor.
Sofia 2 Interpretation of Results
Sofia 2 External Quality Control
(External Positive and Negative Swabs are supplied in the kit)
Quidel Corporation
San Diego, CA 92121 USA
quidel.com
1219205EN00 (06/17)
When the test is complete, the results will be displayed on the Sofia 2 screen. Test Lines will not
be visible to the naked eye.
Results:
The Sofia 2 screen will display results for the procedural control as being
or
. If the
control is
, retest with a new patient sample and new Test Cassette.
Reference the Package Insert for
Warnings and Precautions,
Specimen Collection and Handling,
and
Quality Control
.
Study the Package Insert and User Manual thoroughly
before using Quick Reference Instructions. This is not a
complete Package Insert.
