Product Manual

Sofia Lyme FIA Page 9 of 19
4. Verify that the correct development mode, WALK AWAY or READ NOW, has been selected. Insert the
prepared patient Test Cassette into the drawer of Sofia and gently close the drawer.
5. Sofia will start automatically and display the progress as shown in the example below. In WALK AWAY
Mode, the test results will be displayed on the screen in approximately 10 minutes. In READ NOW Mode,
the test results will be displayed on the screen in approximately 1 minute. See Interpretation of Results
section.
INTERPRETATION OF RESULTS
When the test is complete, the results will be displayed on the Sofia screen. The results will be automatically
printed on the integrated printer if this option is selected. Test Lines, which are fluorescent, cannot be seen
with the naked eye.
The Sofia screen will display results for the procedural controls as being “valid” or “invalid” and will provide a
positive or negative result for the detection of IgM and/or IgG antibodies to B. burgdorferi. If the procedural
controls are “invalid,” retest the patient’s sample with a new Test Cassette.
For example: This display shows that the
test in WALK AWAY Mode has 9 minutes,
14 seconds remaining. Sofia will read and
display the results after 10 minutes.