Product Manual

Sofia Lyme FIA Page 5 of 19
2. Following the prompt on the screen, scan the QC Card (located on the assay kit box).
3. Sofia will prompt the user to select the desired mode (WALK AWAY or READ NOW) and then to run the
External Controls. A full description of each mode can be found in the “Using Sofia” section of this Package
Insert.
4. Use the following procedure to test each of the Control solutions. The Positive Control must be run first,
followed by the Negative Control.
a. Prepare a Positive Control Cassette by adding 2 drops of the Positive
Control solution (red cap) to a Test Cassette sample well. Then follow
the Sofia screen instructions for developing and analyzing the Positive
Control Cassette.
NOTE: The round Test Cassette sample well is located between the
rectangular windows and has a green-tinted sample pad. DO NOT
place sample into the left or right rectangular windows. When adding
drops, hold the bottle vertically so that a complete drop forms.
b. Prepare a Negative Control Cassette by adding 2 drops of the Negative Control solution (white cap) to
a Test Cassette sample well. Then follow the Sofia screen instructions for developing and analyzing the
Negative Control Cassette.
5. After both the Positive and Negative Controls have been run, the results will be displayed as “Passed” or
“Failed.”
Do not perform patient tests or report patient test results if either of the QC test results fail. If both the
Positive and Negative Controls fail, repeat testing with both the Positive and Negative Controls a second time.
If only a single Control fails, the user has the option of repeating both the Positive and Negative Controls or to
repeat only the Control that failed. The user may select “Skip” on the Sofia display to skip the Control test that
previously passed. The QC Results will show a skipped Control test as “unknown.”
Repeat the test or contact Quidel Technical Support at 800.874.1517 (in the U.S.) or 858.552.1100 (outside the
U.S.).
SAMPLE COLLECTION AND STORAGE
Serum or Plasma
Collect and process serum or plasma per standard procedures. Samples may be stored refrigerated (2°C to 8°C)
up to 48 hours, at room temperature (15°C to 30°C) up to 8 hours, and frozen (–20°C) up to 2 freeze/thaw