Product Manual

Sofia Lyme FIA Page 3 of 19
 As the detection reagent is a fluorescent compound, no visible results will form. Sofia must be used for
result interpretation.
 Testing should be performed in an area with adequate ventilation.
 Dispose of containers and unused contents in accordance with Federal, State and Local regulatory
requirements.
 Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this kit.
 Wash hands thoroughly after handling.
 For additional information on hazard symbols, safety, handling and disposal of the components within this
kit, please refer to the Safety Data Sheet (SDS) located at quidel.com.
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 the Test Cassette: Sofia Calibration Check Procedure,
Built-in Procedural Control features, and External Controls.
Sofia Calibration Check Procedure
The Calibration Check Procedure is a required function that checks the Sofia optics and calculation systems
using a specific Calibration Cassette. A Calibration Cassette is shipped with the Sofia Installation Pack.
Important: Ensure that the Calibration Cassette is stored in the provided storage pouch between uses to
protect it 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 with no user input required.
Sofia indicates when the Calibration Check is completed. Select OK to return to the Main Menu.