Product Manual

Patient Test Results
When the test is complete, the results for both the patient specimen
test(s) and for the internal procedural control will be displayed on the
Sofia screen.
The results will be automatically printed on the integrated printer if the
Auto Print option has been selected as the default setting. The results
can also be printed by pushing the PRINT button on Sofia
Refer to the assay-specific package insert for details on how to
interpret results for specific tests.
Note: Once results have been generated for an individual Test
Cassette, Sofia will no longer accept that Cassette a second time.
If the procedural control is “Invalid,” repeat the test with a new patient
sample and a new Cassette. To run another patient specimen, select
Start New Test.
Using the WALK AWAY and READ NOW Modes
with Patient Specimens
WALK AWAY Mode
Use the WALK AWAY Mode for automatically timing the test
development before scanning and displaying the test result, as the user
can walk away during the development mode.
First select the WALK AWAY Mode by using the Up/Down arrows. Then
select OK to confirm.
Sofia will then return to the Start Test screen displaying the newly
selected development mode.
Refer to the assay-specific package insert for sample collection and
preparation procedures.
If required, input or scan the User ID, patient ID and order #. Then press
Start Test, and Sofia drawer will automatically open.
After the user adds the patient sample and inserts the Cassette into
Sofia, Sofia will automatically time the test development, scan, and
display the test result.
READ NOW Mode
Use the READ NOW Mode to allow more efficient throughput of
multiple tests which have been set up and developed on the benchtop
prior to reading.
First select the READ NOW Mode by using the Up/Down arrows. Then
select OK to confirm.
Sofia will then return to the Start Test screen displaying the newly
selected development mode.
Refer to the assay-specific package insert for sample collection and
preparation procedures. Additionally, each assay may have unique
sample stability requirements which can provide workflow options.
Adhere to the extraction procedure for specific specimen extraction.
When ready to test, prepare cassettes to receive the specimen
immediately before use.
Note: Cassettes should not sit open in ambient conditions unless you
are ready to label and use them.
Label the cassettes accordingly and place them in order in the work
area.
Once you have extracted the specimens, you should proceed to the
testing step (Figure 16).
Figure 16
Add extracted specimen #1 to cassette #1, then immediately set your
timer to the designated development time as indicated in the assay-
specific package insert.
1 minute later, add specimen #2 to cassette #2.
Note: Spacing samples apart by 1 minute accounts for the time it
takes to analyze the cassette and report the result. More time may be
required in between each test if data entry is required.
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Installation and Setup
Installation and Setup38
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