Product Manual

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Sofia SARS Antigen FIA Page 4 of 22
KIT STORAGE AND STABILITY
Store the kit at room temperature, 59°F to 86°F (15°C to 30°C), out of direct sunlight. Kit contents are stable
until the expiration date printed on the outer box. Do not freeze.
QUALITY CONTROL
There are three types of Quality Control for Sofia and Sofia 2 and the Test Cassette: Sofia Calibration Check
procedure, built-in procedural control features, and External Controls.
Sofia Calibration Check Procedure
NOTE: This is a “Calibration Check” procedure.
The Calibration Check Procedure should be performed every 30 days. Sofia can be set to remind the user to
complete the Calibration Check Procedure.
The Calibration Check is a required function that checks Sofia optics and calculation systems using a specific
Calibration Cassette. This Calibration Cassette is supplied with the Sofia Installation Pack. Refer to the Sofia
User Manual for details regarding the Calibration Check Procedure.
Important: Ensure that the Calibration Cassette is stored in the provided storage pouch between uses to
protect from exposure to light.
1. To check the calibration of Sofia, select “Calibration” from
the Main Menu.
2. Following the prompts, insert the Calibration Cassette into
Sofia and close the drawer. Sofia performs the Calibration
Check automatically within two minutes with no user input
required.
Sofia indicates when the Calibration Check is completed. Select OK to return to the Main Menu.
NOTE: If the Calibration Check does not pass, notify the on-site Supervisor or contact Quidel Technical Support
for assistance Monday through Friday from 7:00 a.m. to 5:00 p.m. Pacific Time at 800.874.1517 (in
the U.S.); 858.552.1100 (outside the U.S.); Fax: [phone]; [e-mail] (Customer
Service); [e-mail] (Technical Support); or contact your local distributor.
Sofia 2 Calibration Check Procedure
The Calibration Check Procedure should be performed every 30 days. Sofia 2 can be set to remind the user to
complete the Calibration Check Procedure.