27Alere Cholestech LDX
®
System User Manual
External Quality Control
External quality control material should be used to demonstrate
that the reagents and the assay procedure perform properly.
Good Laboratory Practice principles suggest that controls should
be run whenever the laboratory director has any question about
test system integrity, reagent storage conditions, or the reliability
of any test result. If the controls do not perform as expected,
repeat the test or contact Alere before testing patient samples.
Controls should be tested:
• With each new lot of cassettes.
• With every new shipment of cassettes, even if the lot has
been received previously;
• When reagents may have been stored or handled in a way
that can degrade their performance;
• As otherwise required by your laboratory’s standard
quality control procedures;
• As otherwise required by federal, state and local
guidelines.
Record the results in a Quality Control Log.
The quality control results should be in range before
testing patient samples. See “Results Outside the Control
Range” on page 28 if they are not.
Please call Alere to report any problems or if you have any
questions about quality control.
Control Range
Results for Alere™ controls should be within the ranges on the
expected value card, included with the control.
Results Within Control Range
If results for all tests are within the expected ranges for both
levels of controls, patient samples may be tested and the results
reported.
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