Product Manual

Calibration Check
Calibration Check is a required function that ensures optimal
performance by checking the internal Sofia optics and functions.
IMPORTANT: Calibration Check must not exceed 30 days prior to
testing any patient sample.
Perform Sofia Calibration Check
Use the specific Calibration Cassette included with Sofia for the
Calibration Check.
Following the prompts, insert the Calibration Cassette into Sofia and
gently close the drawer. Sofia will perform the Calibration Check
automatically.
The Calibration Cassette will automatically eject when calibration is
complete.
Select OK to return to the Main Menu after calibration is completed.
Caution: Store the Calibration Cassette in the provided
storage pouch at room temperature (15°C to 30°C) between
uses. Improper storage could damage the Calibration
Cassette, which may lead to failed Sofia Calibration Check.
Calibration Results
Sofia displays “Calibration Results” indicating that Calibration Check is
completed. The results will be either “Passed” or “Failed.”
The calibration results are stored and can be recalled with the Review
Calibration Results function of Sofia from the Review Data menu
(page 27).
Note: If Calibration Check does not complete successfully, notify the
on-site Supervisor or contact Quidel Technical Support for assistance
at 800.874.1517 (in the U.S.). For additional contact information
(page 3).
Run QC
External Positive and Negative Quality Controls (QC) may be tested
to demonstrate that the assay-specific reagents, cassettes and assay
procedures are performing properly.
Refer to assay-specific package insert for details on specific tests.
Quidel recommends that External Positive and Negative Controls be run:
◗ Once for each untrained operator, and once for each specific
type of analyte.
◗ Once for each new shipment of kits provided that each different
lot received in the shipment is tested.
◗ As deemed additionally necessary by your internal quality control
procedures, and in accordance with local, state and federal
regulations or accreditation requirements.
Run QC: External Positive and Negative Controls
To run the External Positive and Negative Controls for the specific
test, refer to the assay-specific Package Insert for each specific test for
preparing the test cassettes with QC controls.
Note: The Positive Control must be tested first before testing the
Negative Control.
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.
Main Menu
Run Test
Review Data Calibration
Supervisor
Menu
Change
Mode
Run QC
Main Menu
Run Test
Review Data Calibration
Supervisor
Menu
Change
Mode
Run QC
Installation and Setup
Installation and Setup32
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