Product Manual

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Sofia Strep A FIA
 Do not write on the barcode of the Cassette. This is used by Sofia to identify the type of test being run and to identify
the individual Cassette so as to prevent a second read of the Cassette by the same Sofia.
 Once a Cassette has been successfully scanned by Sofia, do not attempt to scan the Cassette again in the same Sofia.
The barcode on the Cassette contains a unique identifier that will prevent Sofia from performing a second read on a
previously scanned Cassette.
 As the detection reagent is a fluorescent compound, no visible results will form on the test strip. Sofia must be used for
result interpretation.
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 Strep A FIA: 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 is set to remind the user to complete the
Calibration Check Procedure.
The Calibration Check is a required function that checks the Sofia optics and calculation systems using a specific
Calibration Cassette. This Calibration Cassette is shipped 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 it from
exposure to light.
2. Following the prompts, insert the Calibration Cassette into Sofia
and gently close the drawer. Sofia performs the Calibration Check
automatically 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 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.
1. To check the calibration of Sofia, select “Calibration” from the
Main Menu.