Product Manual

Sofia Lyme FIA Page 4 of 19
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] (Technical Support); or
contact your local distributor.
Built-in Procedural Controls
The Sofia Lyme FIA contains a built-in procedural control feature. Each time a test is run, the procedural
control area is scanned by Sofia and the result is displayed on the Sofia screen.
The manufacturer's recommendation for daily control is to document the results of these built-in procedural
controls for the first sample tested each day. This documentation is automatically logged in Sofia with each
test result.
A valid result obtained from the procedural control demonstrates that the test flowed correctly and the
functional integrity of the Test Cassette was maintained. The procedural control is interpreted by Sofia after
the Test Cassette has developed for 10 minutes. If the test does not flow correctly, Sofia will indicate that
the result is invalid. Should this occur, review the procedure and repeat the test with a new patient sample
and a new Test Cassette.
External Quality Control
External Controls are used to demonstrate that the reagents and assay procedure perform properly. Quidel
recommends that Positive and Negative External controls be run:
• Once for each new untrained operator
• 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
For information on how to obtain additional External Controls, contact Quidel Customer Support Services at
800.874.1517 (in the U.S.) or 858.552.1100 (outside the U.S.), or contact your local distributor.
To test External Controls, follow the instructions below.
EXTERNAL QUALITY CONTROL TEST PROCEDURE
1. From the main menu, select Run QC.
For example: This display shows an
invalid result.