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. All specimens must be mixed prior to 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.

Precautions: Users should adhere to standard Universal Precautions when performing this Test Procedure. Precautions may include the use of nitrile gloves, safety glasses and the

covering of any cuts or abrasions on the hands. Wash hands thoroughly after performing this Test Procedure.

Verify that Sofia 2 is set to the

desired mode: WALK AWAY or

READ NOW. See the "Using Sofia

2" section for more information.

Follow Package Insert for

Specimen Collection.

Collect 25 μL (first Graduation) of

Specimen using the Graduated

Pipette provided in the kit.

Note: For Specimens in Transport

Media (preserved), collect 100 μL

(2nd Graduation) using the

Graduated Pipette provided in the kit

Transfer the Specimen to the

Specimen Diluent Tube and mix

the solution by squeezing and

releasing the top bulb of the

Graduated Pipette 3 times.

Remove the Graduated Pipette

from the Specimen Diluent Tube.

Screw the green Dropper

Tip to Specimen Diluent

Tube and mix well.

Remove the small clear cap,

hold the Specimen Diluent

Tube vertical and dispense 5

drops into the Test Cassette

sample well.

Proceed to the next section,

"Using Sofia 2," to complete

the test.

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 2 Campylobacter FIA

and may differ from other Sofia and Sofia 2 FIA procedures.

QUICK REFERENCE

INSTRUCTIONS

For use with Sofia 2.

Test Procedure

WALK AWAY/READ NOW Modes

Refer to the Sofia 2 User Manual.

Sofia 2 may be set to two different modes (WALK AWAY and READ NOW). The procedures for each mode are described below. Note: The Supervisor has

the option to set the Sofia 2 to Locked WALK AWAY mode, which will prevent an operator from selecting any other mode than WALK AWAY for running a

test.

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

Sofia 2 will automatically time the test development, and the results will be

displayed in 15 minutes.

The user places the Test Cassette onto the counter or bench top for 15 minutes (outside of

Sofia 2) and manually times 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.

Warning: Results must not be interpreted past 30 minutes after inoculation. Using the Sofia

2 past this time may result in false results.

Allow the test to develop for the FULL 15 minutes BEFORE placing it into Sofia 2.

WALK AWAY Mode

READ NOW Mode

Using Sofia 2

RUN TEST

1. Input the User ID with the integrated barcode

scanner or enter the data using the on-screen

keypad.

NOTE: If you 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.

4. Insert the Test Cassette into

the drawer. Then gently close

the drawer.

2. Input the Patient ID and/or Order # (if applicable)

using the integrated barcode scanner or enter the

data using the on-screen keypad.

3. Verify that the correct mode (WALK AWAY or

READ NOW) has been selected. Press to open

the Sofia 2 drawer.

NOTE: If the instrument is set in Locked Walk

Away mode, users will only be able to use the

“walk away” mode option for running tests.

Read Now Mode will be grayed out when in

Locked Walk Away Mode.

5. Sofia 2 will start and display the progress. In WALK AWAY Mode, the test

results will be displayed after 15 minutes. 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 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 starting with Step 1 and a new Test Cassette.

Reader Display

Interpretation

Campy

Control

Positive Test for Campylobacter

Campy

Control

Negative Test for Campylobacter

Campy

Control

Result Invalid

Interpretation of Results

From the main menu, select

Run QC.

Follow the prompt on the screen. Scan the QC Card (located on the assay kit box).

Sofia 2 prompts the user to select the desired mode (WALK AWAY or READ NOW).

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 .

Quidel recommends that Positive and Negative External Controls be run:

▪

Once for each untrained operator.

▪

Once for each new shipment of kits –provided that each different lot received in the shipment is tested.

▪

As deemed additionally necessary by your internal quality control procedures, and in accordance with Local, State and Federal regulations or accreditation

requirements.

Intended Use

Sofia 2 Campylobacter FIA employs immunofluorescence for the rapid qualitative detection of a Campylobacter-specific antigen in human fecal specimens. Sofia 2

Campylobacter FIA is designed to detect C. jejuni, C. coli, C. lari and C. upsaliensis from patients with signs and symptoms of gastroenteritis. The test is intended for use

with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient

history.

ASSISTANCE

If you have any questions regarding the use of this product or if you want to report a test system problem, please call Quidel Technical Support 800.874.1517 (in the