Product Manual

Page 9 of 15
Sofia Strep A FIA
5. Sofia will start automatically and display the progress as shown in example below. In the WALK AWAY Mode, the test
results will be displayed on the screen in approximately 5 minutes. In the READ NOW Mode, the test results will be
displayed on the screen in less than 1 minute. See “Interpretation of Results” section.
For example: This display shows that the test in
WALK AWAY mode has 4 minutes, 13 seconds
remaining. Sofia will read and display the results
in about 5 minutes.
INTERPRETATION OF RESULTS
When the test is complete, the results will be displayed on the Sofia screen. The results can be automatically printed on the
integrated printer, if this option is selected. Test Lines, which are fluorescent, will never be visible to the naked eye.
The Sofia screen will display results for the procedural control as being “valid or invalid,” and will provide a positive or
negative result for Strep A. If the procedural control is “invalid,” retest with a new patient sample and a new test Cassette.
NOTE: A positive result does not rule out
co-infections with other pathogens.
Negative Result:
NOTE: A negative result does not rule out
possible other infections.
Invalid Result:
Positive Result:
Invalid Result: If the test is invalid, a new test should be performed
with a new patient sample and a new test Cassette.
For example: This display shows a valid
positive result for Strep A.
For example: This display shows a valid
negative result for Strep A.
For example: This result shows that an
invalid result was obtained.