Test Procedure
Serum/Plasma
Study the Package Insert and User Manual
Instructions. This is not a complete Package Insert.
IMPORTANT! Read instructions carefully before beginning.
and may differ from other Sofia FIA procedures.
1
QUICK REFERENCE
For use with Sofia and Sofia 2.
2 3
5
CLIA Complexity: Moderate
6
4
INSTRUCTIONS
thoroughly before using Quick Reference
The test procedure below is unique to the Sofia Lyme FIA
DO NOT open the foil pouch containing the Test Cassette until ready to test the sample. Place the Test Cassette on a clean and level surface.
All specimens must be at room temperature before testing.
Expiration Date: Check expiration on each individual test package or outer box before using. Do not use any test past the expiration date on the label.
Verify that Sofia or Sofia 2
is set to the desired
mode: WALK AWAY or
READ NOW. See the
"Using Sofia" or “Using
Sofia 2” section for more
information.
Follow Package Insert for
Specimen Collection.
Fill a calibrated micropipette
with 30 μL of the patient
serum/plasma sample.
Add patient sample to the
Reagent Vial and gently mix.
Fill a calibrated micropipette
with 100 μL of diluted sample
from the Reagent Vial.
Align the tip of the micropipette with the round
Test Cassette sample well and empty its contents.
Proceed to the "Using
Sofia" or “Using Sofia
2” section to complete
the test.
Using Sofia
WALK AWAY Mode
READ NOW Mode
Allow the test to develop for the FULL 10 minutes BEFORE placing it into 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.
In WALK AWAY Mode, the user immediately inserts the Test Cassette into Sofia.
The user then returns after 10 minutes to get the test result. In this mode, Sofia will
automatically time the test development before scanning and displaying the test
result.
The user must first place the Test Cassette onto the counter or bench top for 10 minutes
(outside of Sofia) and manually time this development step. Then, the user inserts the Test
Cassette into Sofia. In READ NOW Mode, Sofia will scan and display the test result in
approximately 1 minute.
the recommended development time of 10 minutes.
NOTE: Results will remain stable for an additional 10 minutes after
RUN TEST
screen in approximately 1 minute. See Interpretation of Results section.
When the test is complete, the results will be displayed on the Sofia
Reader Display
Report Result
Interpretation (Presumptive)
IgM: Positive
Procedural Control: Valid
IgM: Negative
Procedural Control: Valid
IgM: Positive
Procedural Control: Valid
IgM: Negative
Procedural Control: Valid
IgM: Invalid
Procedural Control: Invalid
Sofia Interpretation of Results
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 rehighlight the field and simply rescan using
the correct barcode. The previous one will
be overwritten with the right barcode.
2. Input the Patient ID and/or Order # using
the handheld barcode scanner or manually
enter the data using the key pad.
3. Press Start Test and the Sofia
drawer will automatically open.
4. Verify that the correct mode,
WALK AWAY or READ NOW, has
been selected. Insert the Test
Cassette into the drawer. Then
gently close the drawer.
5. Sofia will start automatically and display the progress. In WALK AWAY
Mode, the test results will be displayed on the screen in approximately 10
minutes. In READ NOW Mode, the test results will be displayed on the
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
as being “valid” or “invalid”. If the control is “invalid,” retest starting
IgG: Negative
IgG: Positive
Positive Test for IgM antibodies
to B. burgdorferi
Positive Test for IgG antibodies
to B. burgdorferi
Acute infection to B.b. Test the sample
with IgM Western blot.
Past exposure to B.b. Test the sample
with IgG Western blot.
with step 1 and a new Test Cassette.
IgG: Positive
IgG: Negative
IgG: Invalid
Positive Test for IgM and IgG
antibodies to B. burgdorferi
Negative Test for IgM and IgG
antibodies to B. burgdorferi
Result Invalid
Recent exposure to B.b. Test the
sample with IgM and IgG Western blot.
No evidence of B.b. infection.
If the control is “invalid,” retest starting
with Step 1 and a new Test Cassette.
In WALK AWAY Mode, the user immediately inserts the Test Cassette into Sofia 2.
WALK AWAY Mode
READ NOW Mode
Allow the test to develop for the FULL 10 minutes BEFORE placing it into Sofia 2.
Using Sofia 2
Sofia External Quality Control
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From the main menu, select
Run QC.
Following the prompt on the screen, scan the QC Card (located on the assay kit box).
The user will select the desired mode (WALK AWAY or READ NOW) and then run the
External Controls.
Follow the External Quality Control Test Procedure in the Package Insert to test each
Control, first the Positive Control followed by the Negative Control.
After both the Positive and Negative Controls have been run, the results will be
displayed as “Passed” or “Failed.”
WALK AWAY/READ NOW Modes
Refer to the Sofia 2 User Manual for operating instructions.
Sofia 2 may be set to two different modes (WALK AWAY and READ NOW). The procedures for each mode are described below.
Sofia 2 scans the Test Cassette periodically during the test development time.
Positive test results will be displayed between 3 and 10 minutes.
a positive result in advance of the 10-minute test time only if it detects both a
positive IgM and a positive IgG result. Negative test results will be displayed at 10
minutes.
Sofia 2 will display
The user must first place the Test Cassette onto the counter or bench top for 10 minutes
(outside of Sofia 2) and manually time this development step. Then, the user inserts the Test
Cassette into Sofia 2. In READ NOW Mode, Sofia 2 will scan and display the test result within 1
minute.
RUN TEST
4. Insert the Test Cassette into the drawer. Then gently close the drawer.
When the test is complete, the results will be displayed on the Sofia 2
Reader Display
Report Result
Interpretation (Presumptive)
Procedural Control:
Procedural Control:
Procedural Control:
Procedural Control:
Procedural Control:
Sofia 2 Interpretation of Results
1. Input the User ID using the integrated
barcode scanner or manually enter the
data using the on-screen key pad.
NOTE: If you mistakenly scan the incorrect
barcode, select the field again to rehighlight it. Then simply rescan using the
correct barcode, and the previous one will
be overwritten with the correct barcode.
2. Input the Patient ID and/or Order # using
the integrated barcode scanner or
manually enter the data using the onscreen key pad.
screen. Test Lines, which are fluorescent, will never be visible to the
naked eye.
Results: The Sofia 2 screen will display results for the procedural
control as being
1 and a new Test Cassette.
or . If the control is , retest starting with Step
IgM:
IgG:
IgM:
IgG:
IgM:
IgG:
IgM:
IgG:
IgM:
IgG:
3. Verify that the correct mode,
WALK AWAY or READ NOW,
has been selected. Press
and open the Sofia 2 drawer.
5. Sofia 2 will start automatically and display the progress. In WALK AWAY
Mode, the test results will be displayed on the screen between 3 and 10
minutes. Sofia 2 will display a positive result in advance of the 10-minute
test time only if it detects both a positive IgM and a positive IgG result.
In READ NOW Mode, the test results will be displayed on the screen
within 1 minute. See Interpretation of Results section.
Positive Test for IgM antibodies
to B. burgdorferi
Positive Test for IgG antibodies
to B. burgdorferi
Positive Test for IgM and IgG
antibodies to B. burgdorferi
Negative Test for IgM and IgG
antibodies to B. burgdorferi
Result Invalid
Acute infection to B.b. Test the sample
with IgM Western blot.
Past exposure to B.b. Test the sample
with IgG Western blot.
Recent exposure to B.b. Test the
sample with IgM and IgG Western blot.
No evidence of B.b. infection.
If the control is , retest starting with
Step 1 and a new Test Cassette.
Reference the Package Insert for Warnings and Precautions, Specimen Collection and Handling, and Quality Control.
1 2 3 5 4
Quidel Corporation
Study the Package Insert and User Manual thoroughly
Sofia 2 External Quality Control
From the main menu, select
Run QC.
Following the prompt on the screen, scan the QC Card (located on the assay kit box).
The user will select the desired mode (WALK AWAY or READ NOW) and then run the
External Controls.
Follow the External Quality Control Test Procedure in the Package Insert to test each
Control, first the Positive Control followed by the Negative Control.
After both the Positive and Negative Controls have been run, the results will be
displayed as
or .
INTENDED USE
The Sofia Lyme FIA employs immunofluorescence for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma
specimens from patients suspected of B. burgdorferi infection. This qualitative test is intended for use as an aid in diagnosis of Lyme disease. A negative result does
not preclude infection with B. burgdorferi. All positive results for IgM and/or IgG should be further tested by a corresponding second-tier western blot assay. Test
results are to be used in conjunction with information obtained from the patient’s clinical evaluation and other diagnostic procedures.
ASSISTANCE
If Sofia, Sofia 2, or the assay does not perform as expected, contact Quidel Technical Support 800.874.1517 (in the U.S.), technicalsupport@quidel.com
, or your local
distributor.
1313501EN01 (10/18)
before using Quick Reference Instructions. This is not a
complete Package Insert.
San Diego, CA 92121 USA
quidel.com
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