Product Manual
Set Development Mode and Start QC
Select the desired development mode: WALK AWAY or READ NOW
(see Development Modes section) by using the Left/Right arrows to
highlight the desired mode (Figure 12).
Press START QC to proceed. Sofia will then prompt the User to run the
External Controls.
Prepare a Positive Control Cassette using the Positive Control and the
test procedure instructions in the Package Insert. Follow the screen
instructions to insert the Positive Control Cassette and gently close the
drawer.
When the Positive Control is completed, the drawer will open
automatically. Remove the Positive Control Cassette.
Prepare a Negative Control Cassette using the Negative Control and
the test procedure instructions in the Package Insert. Follow the screen
instructions to insert the Negative Control Cassette and gently close
the drawer.
When the Negative Control is completed, the drawer will open
automatically. Remove the Negative Control Cassette. When the QC
test is complete, the results will be displayed.
QC Results
The displayed results are stored and can be recalled with the Review
QC Results function in the Review Data menu.
Select OK to complete the QC process and return to the Main Menu.
If the QC controls do not pass, repeat the external control testing
process or contact the Supervisor or Quidel Technical Support at
800.874.1517 (in the U.S.) for assistance before testing patient
specimens. For additional contact information (page 3).
Run Patient Specimens
Figure 12
IMPORTANT: Refer to the assay-specific package insert for each
specific test for instructions on preparing Test Cassettes with patient
samples.
In the Main Menu, select RUN TEST to get back to the Start Test screen.
Before entering any User ID or specimen information:
◗
Select the desired Development mode: WALK AWAY or READ
NOW (See description of the WALK AWAY and READ NOW
development modes on page 10).
◗
The current (or default) development mode will be shown at the
top of the Start Test screen (Figure 13). If the default mode is the
desired mode, no changes are required.
◗
If the Supervisor has set the default mode to Locked WALK
AWAY mode, then User will only be allowed to test in the WALK
AWAY mode.
◗
Depending on the assay, Sofia may automatically run the test in
Forced WALK AWAY mode. In this case, no changes need to be
made to the work mode.
Figure 13
Main Menu
Run Test
Review Data Calibration
Supervisor
Menu
Change
Mode
Run QC
Installation and Setup
Installation and Setup34
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