Quidel Lyme fia sofia 2 User manual

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.

Test Procedure

Serum/Plasma

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 Lyme FIA

and may differ from other Sofia FIA procedures.

QUICK REFERENCE

INSTRUCTIONS

For use with Sofia and Sofia 2.

CLIA Complexity: Moderate

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. NOTE: Results will remain stable for an additional 10 minutes after

the recommended development time of 10 minutes.

Using Sofia

WALK AWAY Mode

READ NOW Mode

Allow the test to develop for the FULL 10 minutes BEFORE placing it into Sofia.

RUN TEST

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.

3. Press Start Test and the Sofia

drawer will automatically open.

2. Input the Patient ID and/or Order # using

the handheld barcode scanner or manually

enter the data using the key pad.

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 in approximately 1 minute. See Interpretation of Results section.

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

as being “valid” or “invalid”. If the control is “invalid,” retest starting

with step 1 and a new Test Cassette.

Reader Display

Report Result

Interpretation (Presumptive)

IgM: Positive

IgG: Negative

Procedural Control: Valid

Positive Test for IgM antibodies

to B. burgdorferi

Acute infection to B.b. Test the sample

with IgM Western blot.

IgM: Negative

IgG: Positive

Procedural Control: Valid

Positive Test for IgG antibodies

to B. burgdorferi

Past exposure to B.b. Test the sample

with IgG Western blot.

IgM: Positive

IgG: Positive

Procedural Control: Valid

Positive Test for IgM and IgG

antibodies to B. burgdorferi

Recent exposure to B.b. Test the

sample with IgM and IgG Western blot.

IgM: Negative

IgG: Negative

Procedural Control: Valid

Negative Test for IgM and IgG

antibodies to B. burgdorferi No evidence of B.b. infection.

IgM: Invalid

IgG: Invalid

Procedural Control: Invalid

Result Invalid If the control is “invalid,” retest starting

with Step 1 and a new Test Cassette.

Sofia Interpretation of Results

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.

In WALK AWAY Mode, the user immediately inserts the Test Cassette into Sofia 2.

Sofia 2 scans the Test Cassette periodically during the test development time.

Positive test results will be displayed 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. Negative test results will be displayed at 10

minutes.

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.

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

RUN TEST

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 re-

highlight it. Then simply rescan using the

correct barcode, and the previous one will

be overwritten with the correct barcode.

3. Verify that the correct mode,

WALK AWAY or READ NOW,

has been selected. Press

and open the Sofia 2 drawer.

2. Input the Patient ID and/or Order # using

the integrated barcode scanner or

manually enter the data using the on-

screen key pad.

4. Insert the Test Cassette into the drawer. Then gently close the 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.

When the test is complete, the results will be displayed on the Sofia 2

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 or . If the control is , retest starting with Step

1 and a new Test Cassette.

Reader Display

Report Result

Interpretation (Presumptive)

IgM:

IgG:

Procedural Control:

Positive Test for IgM antibodies

to B. burgdorferi

Acute infection to B.b. Test the sample

with IgM Western blot.

IgM:

IgG:

Procedural Control:

Positive Test for IgG antibodies

to B. burgdorferi

Past exposure to B.b. Test the sample

with IgG Western blot.

IgM:

IgG:

Procedural Control:

Positive Test for IgM and IgG

antibodies to B. burgdorferi

Recent exposure to B.b. Test the

sample with IgM and IgG Western blot.

IgM:

IgG:

Procedural Control:

Negative Test for IgM and IgG

antibodies to B. burgdorferi No evidence of B.b. infection.

IgM:

IgG:

Procedural Control:

Result Invalid If the control is , retest starting with

Step 1 and a new Test Cassette.

Sofia 2 Interpretation of Results

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.), technicals[email protected], or your local

distributor.

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