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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 

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

 

1

 

2

 

4

 

5

 

3

 

6

 

x5 

Summary of Contents for Lyme FIA Sofia 2

Page 1: ...irst 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 Diluen...

Page 2: ...fia 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 in...

Page 3: ...d 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 ...

Page 4: ...or 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 conjunctio...

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