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Sofia 2 Support


Get Connected: Visit ConnectMe.quidel.com for help connecting your Quidel Instruments to LIS or the cloud, including how to get started and use the Virena test results surveillance system.

Get the latest updates: After your Sofia 2 has been setup register your Sofia 2 instrument at MyQuidel.com to download and install the latest Software Updates, Assay and testing capabilities for your Sofia 2 Instruments.

Please follow the below five step process to get your Sofia 2 instrument setup

  • Setup & Calibrate
  • Run Quality Control
  • Run Patient Specimens
  • Watch Videos
  • Training Certificate
Next Step - Setup & Calibrate

Get Connected: Visit ConnectMe.quidel.com for help connecting your Quidel Instruments to LIS or the cloud, including how to get started and use the Virena test results surveillance system.

Get the latest updates: After your Sofia 2 has been setup register your Sofia 2 instrument at MyQuidel.com to download and install the latest Software Updates, Assay and testing capabilities for your Sofia 2 Instruments.

Just received your Sofia 2? 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 2 and Sofia 2 Installation Pack

Install Sofia 2

CONNECT TO POWER AND TURN ON
Place Sofia 2 on the counter top within reach of an electrical outlet. The unit is portable and can be moved to a suitable location for testing.
  1. Plug the Power Adapter into the power port on the rear panel of Sofia 2 and appropriate electrical outlet.
  2. Turn Sofia 2 on using the power switch located on the rear panel. A Power On Self-Test screen will appear on the front display when Sofia 2 is turned on.

Set up Virena

ENTER ZIP CODE
When prompted, enter the ZIP Code where Sofia 2 is located and select to confirm. Sofia 2 will then advance to the Run Test screen.


TEST VIRENA CONNECTION
From the Main Menu, select Send Data. Then select Test connection and press to test the Virena connection.

If the connection is successful, the message Test connection success. Signal strength -##dBm. will appear. Sofia 2 is now connected to Virena. If the connection is unsuccessful, contact Technical Support.


Continue to Run Calibration.

CUSTOMERS WITHOUT VIRENA ACTIVATED
For Sofia 2 customers without Virena activated, testing the connection will result in the message Send To Virena Error. Unable to Acquire Cellular Connection. or the Test Connection pop up window could continue for several minutes requiring the user to restart the instrument. To prevent this message from reappearing, select Supervisor Menu from the Main Menu. Then select Network Settings, then Virena Settings. Configure settings to the following:

Press to confirm changes and return to the Run Test screen.

Run Calibration Check

RUN CALIBRATION
  • Enter the default Supervisor ID of 1234.
  • Remove Calibration Cassette from the pouch.
  • Press to advance to the next screen.
Following the prompts, insert the Calibration Cassette into Sofia 2 and gently close the drawer. Sofia 2 will perform the Calibration Check automatically.


The Sofia 2 display will indicate when the Calibration Check is completed.

NOTE: If Calibration Check cannot be completed successfully, notify the on-site Supervisor or contact Quidel Technical Support for assistance.

Once calibration is complete, remove and return Calibration Cassette to the storage pouch.

Important: Store the Calibration Cassette in the provided storage pouch between uses. Avoid touching the read window on the Calibration Cassette.
Important: A Calibration Check must be performed on your Sofia 2 every 30 days

Additional Settings

Please refer to the Sofia 2 User Manual for additional instrument settings, including:
  • Date/Time
  • User and Patient ID entry requirements
  • Default mode and timeout settings
  • Ethernet and LIS
  • User Management
Next Step - Run Quality Control

Get Connected: Visit ConnectMe.quidel.com for help connecting your Quidel Instruments to LIS or the cloud, including how to get started and use the Virena test results surveillance system.

Get the latest updates: After your Sofia 2 has been setup register your Sofia 2 instrument at MyQuidel.com to download and install the latest Software Updates, Assay and testing capabilities for your Sofia 2 Instruments.

Running Quality Control On Your Sofia 2

Before You Begin: Review Previous Quality Control Results

  1. From the MAIN MENU, select REVIEW DATA, then select QC RESULTS.
  2. The previous QC Results will be displayed. (NOTE: With a new Sofia 2, this section will be blank.)
  3. Quidel recommends that Positive and Negative External Controls be run:
    • Once for each untrained operator
    • Once for each new lot and shipment
    • As deemed additionally necessary by your internal quality control procedures, and in accordance with Local, State and Federal regulations or accredidation requirements.
    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
    • 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. From the MAIN MENU, select RUN QC
  4. When prompted, use the Barcode Scanner to scan your user ID, or tap the "User ID" field to enter User ID with the onscreen keyboard
  5. When prompted, use the Barcode Scanner to scan the QC Card included in the kit specific for the test and kit lot to be evaluated. This card provides Sofia 2 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 radio buttons to select the desired mode.
  2. Press to proceed. Sofia 2 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, Sofia 2 will prompt you to open the drawer and remove the Positive Control Cassette.
    IMPORTANT: When the positive control is completed, two icons will appear at the bottom of the screen – a >>| and a >. Pressing > will take you to the next step, which is to complete the negative control. Pressing >>| will skip the negative control, canceling the QC. If this happens, you will need to begin the QC process again from step 1.
  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 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

Get Connected: Visit ConnectMe.quidel.com for help connecting your Quidel Instruments to LIS or the cloud, including how to get started and use the Virena test results surveillance system.

Get the latest updates: After your Sofia 2 has been setup register your Sofia 2 instrument at MyQuidel.com to download and install the latest Software Updates, Assay and testing capabilities for your Sofia 2 Instruments.

Running Patient Specimens On Your Sofia 2

Get Started

  1. The Sofia 2 "Home" screen is the "Run Test" screen. To get the "Run Test" screen from any other screen, select or select then "Run Test".

Enter the User ID

Use the Barcode Scanner to scan the barcode from a User's ID Card or tap User ID field to manually enter the data using the onscreen keyboard on Sofia 2.

Note that User ID can be configured on Sofia 2 to be either required or optional


Enter the Patient ID

Use the Barcode Scanner to scan a patient ID barcode from a patient chart or other source, or tap Patient ID field to manually enter the data using the onscreen keyboard on Sofia 2.

Note that Patient ID can be configured on Sofia 2 to be either required or optional

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 tap Order ID field to manually enter the data using the onscreen keyboard on Sofia 2.

Select WALK AWAY or READ NOW Development Mode

  1. Select the desired development mode: WALK AWAY or READ NOW by using the radio buttons to select the desired mode.
  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 2 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.

START TEST

  1. Press and follow the onscreen prompts to start the test.
  2. Open the drawer and insert the Test Cassette. Gently close the drawer.
  3. Upon closing the drawer, Sofia 2 will start automatically and display the progress as shown in the example below.

    This example shows that the test in WALK AWAY Mode has 12 minutes, 34 seconds remaining. Sofia 2 will read and display the results between 3 and 15 minutes. 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 2 screen.
  2. If a printer is connected, the results can be printed manually by selecting the print icon while the test results are displayed on the screen.
  3. Refer to the Package Insert for each test for details on how to interpret results for specific tests.

    This above example shows a valid positive result for Influenza A.

    In the example above, the internal procedural control was invalid; therefore, the patient specimen test results were invalid, as shown.
    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 by holding the power switch in the rear of the unit.
  2. Shutdown is complete when the screen goes dark.
Next Step - Watch Videos

Get Connected: Visit ConnectMe.quidel.com for help connecting your Quidel Instruments to LIS or the cloud, including how to get started and use the Virena test results surveillance system.

Get the latest updates: After your Sofia 2 has been setup register your Sofia 2 instrument at MyQuidel.com to download and install the latest Software Updates, Assay and testing capabilities for your Sofia 2 Instruments.

Introduction

Module 1 - Unpacking

Module 2 - Calibrating

Module 3 - Configuring Sofia 2 and Virena

Module 4 - Performing QC

Nasal Swab Sample Collection

Module 5 - Performing Testing (Sofia Influenza A+B FIA)

Module 5 - Performing Testing (Sofia SARS Antigen FIA)

Sofia SARS Antigen FIA Batch Testing Protocol

Module 5 - Performing Testing (Sofia RSV FIA)

Module 5 - Performing Testing (Sofia Strep A+ FIA)

Module 5 - Performing Testing (Sofia 2 Lyme FIA)

Module 6 - Maintaining Sofia 2

Next Step - Run Patient Specimens

Obtain your Training Certificate


Also, be sure to visit myquidel.com to register your Sofia 2 analyzer and download and install the latest Software Updates, Assay and testing capabilities for your Sofia 2 instruments.

Sofia 2 Resources

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Sofia Influenza A+B FIA Resources

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Sofia SARS Antigen FIA Resources

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Sofia 2 Flu + SARS Antigen FIA Resources

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Sofia RSV FIA Resources

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Sofia Strep A+ FIA Resources

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Sofia Lyme FIA Resources

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Sofia 2 Lyme FIA Resources

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Virena Resources

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How To Buy

OR - Contact Your Local Distributor

Evaluate a Kit