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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

 

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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