Magellan LeadCare II - Chapter 3 Quality Control Procedure; What is a LeadCare II Lead Control; Storage and Handling

LeadCare
®
II User's Guide 3-1
Chapter 3 Quality Control Procedure
Magellan Diagnostics provides the LeadCare
®
II Controls in the test kit for quality
control. The Level 1 and Level 2 controls are used to verify system performance
and accuracy. This chapter covers the following information:
• What is a LeadCare II Lead Control
• Storage and Handling
• How Often Should You Test Controls
• Testing Controls
• Interpreting the Control Test Results
What is a LeadCare II Lead Control
A control is a standard against which test results can be evaluated. The
LeadCare II controls are room temperature stable solutions designed to mimic
blood, and spiked with lead to specific target values. The product is supplied in a
two level format. Each is assigned a target lead value with an associated
acceptable range.
The testing of controls will ensure your LeadCare II Blood Lead Analyzer is
reporting accurate results.
Storage and Handling
The control material is supplied in liquid form and ready to use. It should be
stored at room temperature and should not be used beyond its expiration date.
CAUTION: Controls should only be used with sensors of the
same lot number. Discard remaining control solutions when the
sensors are gone. Failure to do so may result in inaccurate
patient results.