Magellan LeadCare II - Control Test Results Above the Target Range: Possible Causes

LeadCare
®
II User's Guide 5-5
Testing Conditions
• Do NOT operate the LeadCare II System in drafty locations.
• Make sure that the analyzer and the test kit are maintained at a constant
temperature. If you move any part of the system from one place to another, (for
example, from outside into a laboratory) wait for the analyzer and components to
reach a stable temperature.
User Technique
• Do NOT touch the black bars on the sensor.
• Make sure the sensor is inserted under the sensor guides and sits flush on the
sensor deck.
• Do NOT touch the sensor while the analyzer is running a test.
• Make sure the control and treatment reagent is thoroughly mixed before placing
onto the sensor. The mixture will appear red.
Control Test Results Above the Target Range: Possible Causes
Possible causes of high control test results include:
• Control lot number does not match the sensor lot and calibration code.
• More than 50 µL of control material was transferred to treatment reagent.
• The test sample is warmer than detected by the analyzer.
• The analyzer is not properly calibrated.
See detailed precautions below:
Control Sample Preparation
• Use the capillary tube and plunger to transfer 50 µL of blood into the treatment
reagent vial.
• Wipe excess sample off the outside of the capillary tube with a clean gauze pad or
laboratory wipe before adding the control to treatment reagent.
Equipment Setup, Calibration and Testing Materials
• Make sure the controls were properly stored: Room temperature storage is
considered 15 - 27ºC (59 - 80ºF).
• Check the expiration date on the control vial to verify the controls have not expired.
• Make sure that the lot number of the control matches the lot number on the sensor
container and the lot number on the display screen.
NOTE:
The controls are only intended for use with the test kit in which
they come. When the other reagents included in the test kit are
used up, discard the controls.