Quick Reference Instructions
QUICK REFERENCE
INSTRUCTIONS
For use with Sofia only.
Study the Package Insert and User Manual thoroughly
before using Quick Reference Instructions. This is not a
complete Package Insert.
IMPORTANT! Read instructions carefully before beginning.
The test procedure below is unique to the Sofia Strep A FIA
and may differ from other Sofia FIA procedures.
Test Procedure
1
2
3
4
5
6
Verify that Sofia is set to
the desired Mode: WALK
AWAY or READ NOW. See
the “Using Sofia” section
for more information.
Squeeze ONCE to break the
glass ampoule inside the
Reagent Solution Bottle, just
prior to running the assay.
Vigorously shake the Bottle five times
to mix the solutions. Solution should
turn green after the ampoule is broken.
Remove the cap. Holding Bottle
vertically, fill the Reagent Tube to
the line (approximately 6 drops).
Immediately add the patient Swab
sample to the Reagent Tube.
Leave the Swab in the
Reagent Tube for
1 minute.
Vigorously mix the solution by
plunging the Swab five (5) times in
an up and down motion in the tube.
NOTE: Best results are obtained when
the specimen is vigorously extracted in
the solution.
1
!
Vigorously
plunge up
and down
5x
Leave for
1 minute.
Fill to Line
7
8
9
Vigorously mix the solution again by
plunging the Swab five (5) times in
an up and down motion in the Tube.
Express as much liquid as possible
from the Swab by squeezing the
sides of the Tube as the Swab is
withdrawn.
Fill the provided yellow Fixed Volume Pipette
with the sample:
Discard the Swab in accordance
with your biohazard waste disposal
protocol.
a) FIRMLY squeeze the top bulb.
10
To fill the Fixed Volume Pipette (100 µL) with
the sample:
b) Still squeezing, place the Pipette tip into the
sample.
c) With the Pipette tip still in the sample,
release pressure on bulb to fill the Pipette.
11
Firmly squeeze the top bulb to empty the
contents of the Fixed Volume Pipette into
the Cassette sample well. Extra liquid in the
overflow bulb is OK.
Proceed to the next section,
“Using Sofia,” to complete
the test.
NOTE: The Fixed Volume Pipette is designed
to collect and dispense the correct amount
of patient sample. Discard the Pipette in your
biohazard waste.
Squeeze
here
!
Pipette
P
E
R
T
S
Vigorously
plunge up
and down
5x
A
Sample Well
Sample
Using Sofia
WALK AWAY/READ NOW Modes
Refer to the Sofia User Manual for operating instructions.
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 Cassette into Sofia. The user
then returns after 5 minutes to get the test result. In this mode, Sofia will automatically
time the test development before scanning and displaying the test result.
Allow the test to develop for the full 5 minutes BEFORE placing it into Sofia.
5
The user must first place the Cassette onto the counter or bench top for 5 minutes
(outside of Sofia) and manually time this development step. Then, the user inserts the
Cassette into Sofia. In READ NOW Mode, Sofia will scan and display the test result
within 1 minute.
1
5
r Feed
Pape
A+B
FLU
Reader
A+B
FLU
Reader
Print
Eject
T
S
P
E
R
T
S
P
E
R
T
S
P
E
R
A
A
A
Using Sofia (cont.)
RUN TEST
3. Press Start Test and the Sofia
drawer will automatically open.
1. Input the User ID using the handheld
barcode scanner or manually enter
the data using the key pad.
NOTE: If you mistakenly scan the
wrong barcode, use the Arrow Keys
on Sofia to re-highlight the field
and simply rescan using the correct
barcode. The previous one will be
overwritten with the right barcode.
r Feed
Pape
Print
ID
B005
tor
Opera
Eject
A+B
r Feed
Pape
FLU
4. Verify that the correct mode,
WALK AWAY or READ NOW,
has been selected. Insert the
Cassette into the drawer. Then
gently close the drawer.
Reader
2. Input the Patient ID and/or Order #
using the handheld barcode scanner
or manually enter the data using the
key pad.
Print
ID
B005
tor
Opera
Eject
5. Sofia will start automatically and display the progress. In WALK AWAY
Mode, the test results will be displayed on the screen in approximately
5 minutes. In READ NOW Mode, the test results will be displayed on the
screen within 1 minute. See Interpretation of Results section.
Interpretation of Results
When the test is complete, the results will be displayed on the Sofia screen. The results can
be automatically printed on the integrated printer if this option is selected. Test Lines, which
are fluorescent, will never be visible to the naked eye.
Results: The Sofia screen will display results for the procedural control being “valid or
invalid.” If the control is “invalid,” retest with a new patient sample and new test Cassette.
Reader Display
Interpretation
Strep A: Positive
Positive Test for Strep A
(Strep A antigen present)
Strep A: Negative
Negative Test for Strep A
(no antigen detected)
Strep A: Invalid
Procedural Control: Invalid
Result Invalid
External Quality Control (External Positive and Negative Swabs are supplied in the kit)
1
From the main menu, select Run QC.
2
Following the prompt on the screen, scan the QC Card (located on the kit box).
3
Sofia will then prompt the user to run the External Control Swabs.
4
Follow the Test Procedure of this Quick Reference Instructions.
INTENDED USE
The Sofia Strep A FIA employs immunofluorescence technology to detect Group A Streptococcal antigens from throat swabs of symptomatic patients. All negative test results should
be confirmed by bacterial culture because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for
professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection.
Reference the Package Insert for Warnings and Precautions, Specimen Collection and Handling, and Quality Control.
ASSISTANCE
If Sofia 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.), technicalsupport@quidel.com,
or your local distributor.
Study the Package Insert and User Manual thoroughly
before using Quick Reference Instructions. This is not a
complete Package Insert.
Quidel Corporation
San Diego, CA 92121 USA
quidel.com
1192502 (01/14)
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