Product Manual

Reader Display
Interpretation
Flu A:
Flu B:
SARS:
Procedural Control:
Positive Test for Flu A
(influenza A antigen present)
Flu A:
Flu B:
SARS:
Procedural Control:
Positive Test for Flu B
(influenza B antigen present)
Flu A:
Flu B:
SARS:
Procedural Control:
Positive Test for SARS
(SARS antigen present)
Flu A:
Flu B:
SARS:
Procedural Control:
Positive Test for both Flu A and SARS
(influenza A and SARS antigen present)
Flu A:
Flu B:
SARS:
Procedural Control:
Positive Test for both Flu B and SARS
(influenza B and SARS antigen present)
Flu A:
Flu B:
SARS:
Procedural Control:
Negative Test for Flu A, Flu B, and SARS
(no antigen detected)
Flu A:
Flu B:
SARS:
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 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2. Sofia 2 Flu + SARS Antigen FIA is intended for the simultaneous
qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B in direct nasopharyngeal (NP) and nasal (NS) swab specimens
Sofia 2 Interpretation of Results
Sofia 2 External Quality Control (External Positive and Negative Swabs are supplied in the kit)
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.
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