Product Manual

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Sofia SARS Antigen FIA Page 8 of 22
4. Roll the swab head against the inside of the Reagent Tube as you remove it.
Dispose of the used swab in your biohazard waste.
5. Fill the provided Small, Clear 120 µL Fixed Volume Pipette with the patient
sample from the Reagent Tube.
To fill the Fixed Volume Pipette with the patient sample:
a) FIRMLY squeeze the top bulb.
b) Still squeezing, place the Pipette tip into the patient sample.
c) With the Pipette tip still in the patient sample, slowly release pressure
on bulb to fill the Pipette.
6. 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 left over in
the overflow bulb should be left behind.
NOTE: The Fixed Volume Pipettes are designed to collect and dispense the
correct amount of liquid sample. Discard the pipette in your biohazard
waste.
NOTE: Do not pour sample from the Reagent Tube. Use the provided
Small, Clear 120 µL Fixed Volume Pipette.
7. Promptly proceed to the next section, “Using Sofia and Sofia 2,” to complete the
test.
USING SOFIA AND SOFIA 2
WALK AWAY/READ NOW Modes
Refer to the Sofia 2 User Manual for operating instructions.
Sofia and Sofia 2 may be set to two different modes (WALK AWAY and READ NOW). The procedures for each
mode are described below.
WALK AWAY Mode
In WALK AWAY Mode, the user immediately inserts the Test Cassette into Sofia or Sofia 2. Sofia and Sofia 2
scan the Test Cassette periodically during the test development time. Positive and negative test results will be
displayed in 15 minutes.
READ NOW Mode
Critically important: Allow the test to develop for the FULL 15 minutes BEFORE placing it into Sofia or Sofia 2.
The user must first place the Test Cassette onto the counter or bench top for 15 minutes (outside of Sofia 2)
and manually time this development step. Then, the user inserts the Test Cassette into Sofia or Sofia 2. In
READ NOW Mode, Sofia and Sofia 2 will scan and display the test result within 1 minute