Product Manual

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Sofia Strep A FIA
Each time a test is run in Sofia, a procedural control is interpreted by
Sofia and the result is displayed on the Sofia screen. This information
is automatically logged in Sofia with each test result. A valid result
obtained with the procedural control demonstrates that the extracted
specimen flowed correctly and the functional integrity of the Cassette
was maintained. This procedural control is interpreted by Sofia after
the Cassette has developed for 5 minutes. If the specimen has not
flowed 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.
Built-in Procedural Controls
The Sofia Strep A FIA contains two built-in procedural control features. The manufacturer’s recommendation for daily
control is to document these built-in procedural controls for the first sample tested each day.
A control of the extraction procedure is provided by a color change from clear to green as the Reagent Solution is mixed.
The color change is an indication of Reagent Solution integrity and is also an indication that the extraction procedure was
performed correctly.
For example: This result shows that
an invalid result had occurred.
External Quality Control
External Controls may also be used to demonstrate that the reagents and assay procedure perform properly.
Quidel recommends that Positive and Negative Controls be run:
 once for each untrained operator;
 once for each new shipment of kits-provided that each different lot received in the shipment is tested; and
 as deemed additionally necessary by your internal quality control procedures, and in accordance with Local, State and
Federal regulations or accreditation requirements.
The user must first select Run QC on the Main Menu of Sofia and then, when prompted, scan the QC Card (located on the
kit box). This card provides information specific to the kit lot, including lot number and expiration date.
Sofia will prompt the user to select the desired mode (WALK AWAY or READ NOW) and then to run the External Control
Swabs.
External Positive and Negative Control Swabs are supplied in the kit and should be tested using the Test Procedure
provided in this Package Insert or in the Quick Reference Instructions. Additional External Control Swabs may be obtained
separately by contacting Quidel’s Customer Support Services at 800.874.1517 (in the U.S.) or 858.552.1100 (outside the U.S.).
When the QC test is complete, each result will be displayed as “Passed” or “Failed” for the Positive Control and the
Negative Control.
Do not perform patient tests or report patient test results if the QC test does not produce the expected results. Repeat the
test or contact Quidel Technical Support before testing patient specimens if a “Failed” result is obtained with the External
Controls.