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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. 

     

 

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 15 minutes. Negative test 
results will be displayed at 15 minutes. 

 

The user first places the Test Cassette onto the counter or bench top for 15 minutes 
(outside of Sofia 2). The user manually times this development step. The Test Cassette 
MUST remain on the bench for 15 minutes to get an accurate result. 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. 

Note:

 Results will remain stable for an additional 15 minutes after 

the recommended development time of 15 minutes. 

 

 

 

 

 

 

 

RUN TEST 

1.

 

Input the User ID with the integrated barcode scanner 
or manually enter the data using the key pad. 

NOTE

If you scan the wrong barcode, re-highlight the 

field using the touchscreen on Sofia 2. The previous 
one will be overwritten with the right barcode.

 

 

3.

 

Verify that the correct mode (WALK 
AWAY or READ NOW) has been 
selected. Press    and open the Sofia 
2 drawer. 
 
 

4.

 

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

 

2.

 

Input the Patient ID and Order # (if applicable) with 
the integrated barcode scanner or manually enter the 
data using the key pad. 

 

5.

 

Sofia 2 will start automatically and display the progress. In WALK AWAY 
Mode, the test results will be displayed in approximately 15 minutes. In 
READ NOW Mode, the test results will be displayed within 1 minute. See 
Sofia 2 Interpretation of Results section. 

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

Using Sofia 2 

 WALK AWAY Mode 

 READ NOW Mode 

Summary of Contents for Sofia Influenza A+B

Page 1: ... bulb b Still squeezing place the Pipette tip into the sample c With the Pipette tip still in the sample release pressure on bulb to fill the Pipette Firmly squeeze the top bulb to empty the contents of the Small Clear 120 µL Fixed Volume Pipette into the Test Cassette sample well Extra liquid in the overflow bulb is OK NOTE The Fixed Volume Pipette is designed to collect and dispense the correct ...

Page 2: ...he collection cup Firmly squeeze the top bulb to empty the contents of the Large Pink 250 µL Fixed Volume Pipette into the Reagent Tube Extra liquid in the overflow bulb is OK NOTE Once the sample is added to the Reagent Tube vigorously mix prior to adding the sample to the Test Cassette NOTE The Fixed Volume Pipette is designed to collect and dispense the correct amount of patient sample Discard ...

Page 3: ...mended development time of 15 minutes RUN TEST 1 Input the User ID with the barcode scanner or enter the data using the key pad NOTE If you 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 open 4 Verify that the correct mod...

Page 4: ...Flu B Positive Procedural Control Valid Positive Test for both Flu A and Flu B influenza A and B antigen present Flu A Negative Flu B Negative Procedural Control Valid Negative Test for Flu A and Flu B no antigen detected Flu A Invalid Flu B Invalid Procedural Control Invalid Result Invalid From the main menu select Run QC Follow the prompts on the screen Scan the QC Card located on the kit box So...

Page 5: ...in stable for an additional 15 minutes after the recommended development time of 15 minutes RUN TEST 1 Input the User ID with the integrated barcode scanner or manually enter the data using the key pad NOTE If you scan the wrong barcode re highlight the field using the touchscreen on Sofia 2 The previous one will be overwritten with the right barcode 3 Verify that the correct mode WALK AWAY or REA...

Page 6: ...in the rapid differential diagnosis of acute influenza A and influenza B viral infections The test is not intended to detect influenza C antigens A negative test is presumptive and it is recommended these results be confirmed by viral culture or an FDA cleared influenza A and B molecular assay Negative results do not preclude influenza virus infections and should not be used as the sole basis for ...

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