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Sofia Support

Please follow the below three step process to get your Sofia instrument setup

  • Setup & Calibrate
  • Run Quality Control
  • Run Patient Specimens

Get the latest updates: After your Sofia has been setup you may register at MyQuidel.com to download and install the latest Software Updates, Assay and testing capabilities for your Sofia Instruments.

Next Step - Setup & Calibrate

Just received your Sofia? Start here!

Before you begin:
  • Inspect the shipping container for obvious shipping damage prior to opening.
  • Unpack the shipping container and inspect the unit and all components.

Unpack the Sofia

Unpack the Installation Pack

Connect to Power and Turn On

Place Sofia on the counter top within reach of an electrical outlet. The unit is portable and can be moved to a suitable location for testing.



Run Calibration Check

  1. Use the up/down keys to highlight CALIBRATION from the menu.
  2. Press the soft key under the lower right corner of the display screen under SELECT. Cassette drawer will automatically open.
  3. Remove Calibration Cassette from the pouch.
  4. Insert the Calibration Cassette into Sofia and close the drawer. Sofia will perform the calibration automatically.
  5. The Sofia display will indicate when the calibration is completed.
  6. After successful calibration, select OK to return to the Main Menu.
  7. Return the Calibration Cassette to the storage pouch. Be sure to store the Calibration Cassette in the provided storage pouch between uses.
NOTE: If calibration cannot be completed successfully, notify your Supervisor or contact a Sofia Technical Support Specialist for assistance.
IMPORTANT: A Calibration Check must be performed on your Sofia every 30 days.

Load Test Type Files

  1. Select LOAD TEST TYPE from the Supervisor menu.
  2. Insert the SD Card with the test type files to be installed and select OK.
  3. Sofia will load the test types that are on the SD Card if they are not already in Sofia.
  4. Sofia will display the test types that are newly installed.
  5. Press OK to acknowledge.
Next Step - Run Quality Control

Running Quality Control On Your Sofia

Before You Begin: Review Previous Quality Control Results

  1. From the MAIN MENU, select REVIEW DATA, then select REVIEW QC RESULTS.
  2. The previous QC Results will be displayed. (NOTE: With a new Sofia, this section will be blank.)
  3. If the appropriate External Controls have been run for the specific test per your site's requirements, skip the rest of this section and go to the Run Patient Specimens page. If not, continue to the following step.

Run External Positive and Negative Controls

  1. Collect the following supplies provided by Quidel with each test kit:
    • Positive Control and Negative Control
    • Two Test Cassettes
    • QC Card
    • Package Insert for that specific test

    IMPORTANT: The Positive Control must be tested first, before testing the Negative Control.
  2. Run external controls as indicated in the package insert.
  3. When prompted, use the Barcode Scanner to scan the QC Card specific for the test and kit lot to be evaluated. This card provides Sofia with specific information, including the kit lot number and expiration date.

Set Development Mode and Start Quality Control

  1. Select the desired development mode: WALK AWAY or READ NOW by using the right/left keys to highlight the desired mode.
  2. Press START QC to proceed. Sofia will then prompt the User to run the External Controls.
  3. Prepare a Positive Control Cassette using the Positive Control and the test procedure instructions in the Package Insert.
  4. Follow the screen instructions to insert the Positive Control Cassette and gently close the drawer.
  5. When the Positive Control is completed, the drawer will open. Remove the Positive Control Cassette.
  6. Prepare a Negative Control Cassette using the Negative Control and the test procedure instructions in the Package Insert.
  7. Follow the screen instructions to insert the Negative Control Cassette and gently close the drawer as shown for the positive control.
  8. When the QC test is complete, the results will be displayed. The displayed results are stored and can be recalled with the REVIEW QC RESULTS function in the Review Data menu.
NOTE: If the QC controls do not perform as expected, repeat the external control testing process. You may also contact your Supervisor or a Sofia Technical Support Specialist at 800.874.1517, option 2 for assistance before testing patient specimens.
Next Step - Run Patient Specimens

Running Patient Specimens On Your Sofia

Get Started

  1. If the Main Menu is displayed, select RUN TEST to get back to the Start Test screen.
  2. Before entering any User ID or specimen information, select the desired development mode (WALK AWAY or READ NOW). The current (or default) development mode will be shown at the top of the Start Test screen.
  3. To change the development mode:
    1. Go to the Main Menu
    2. Select CHANGE MODE
    3. Use up or down arrows to highlight the desired development mode
    4. Select OK. Sofia will then return to the Start Test screen displaying the newly selected development mode.

Enter the User ID

Use the Barcode Scanner to scan the barcode from a User's ID Card or manually enter the data using the numeric key pad on Sofia.


Enter the Patient ID

Use the Barcode Scanner to scan a patient ID barcode from a patient chart or other source, or manually enter the data using the numeric key pad on Sofia.

Enter the Order Number, if applicable

  1. Use the Barcode Scanner to scan an order # barcode from a patient test requisition or other source or manually enter the data using the numeric key pad on Sofia.
  2. In the WALK AWAY development mode, proceed directly to the next step as soon as the patient specimen has been processed and added into the Test Cassette.
  3. In the READ NOW development mode, remember to first manually time the test development of the patient specimen Test Cassette outside Sofia at room temperature for the required period of time (as defined in the Package Insert for the specific test) before proceeding to the next step.

Press START TEST

  1. The Sofia drawer will automatically open.
  2. Insert the Test Cassette into the drawer and gently close the drawer.
  3. Upon closing the drawer, Sofia will start automatically and display the progress as shown in the example below.

    The example above shows the display for a test running in WALK AWAY Mode with 12 minutes and 13 seconds remaining before results will be available. In this case the example is for Sofia Influenza A+B FIA.

Obtain Patient Specimen Test Results

  1. 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.
  2. The results will be automatically printed on the integrated printer if this option has been selected as the default setting. The results can also be printed by pushing the PRINT button on Sofia.
  3. Refer to the Package Insert for each test for details on how to interpret results for specific tests.

    In the example above, the internal procedural control was invalid; therefore, the patient specimen test results were invalid, as shown.

    In the example above, the internal procedural control was valid; the patient specimen was positive for Influenza A and negative for Influenza B.

    IMPORTANT: Once results have been generated for a Test Cassette, DO NOT USE that Test Cassette again. 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."

Shutdown

  1. Turn off the unit using the power switch in the rear of the unit. The "Switching Off" screen will be displayed, followed by a brief "Please wait..." prompt.
  2. Shutdown is complete when the screen goes dark.

Main Module - Setup and Installation Video

Module 1 - Installing Sofia

Module 2 - Loading the Test Type Files

Module 3 - Calibrating Sofia

Module 4 - Changing the Settings

Module 5 - Managing User Accounts

Module 6 - Saving Data

Module 7 - Reviewing Sofia Data and Statistics

Module 8 - Changing the Workflow Modes

Module 9 - Maintaining Sofia

Module 10 - Performing the QC Test

Sofia Resources

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Sofia hCG FIA Resources

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Sofia Influenza A+B FIA Resources

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Sofia RSV FIA Resources

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Sofia Strep A+ FIA Resources

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Sofia Strep A FIA Resources

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Training Resources

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Virena Resources

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