Results Outside The Control Range - Alere Cholestech LDX System User Manual

Results Outside the Control Range

If results of one or both levels of control tested are outside the
established ranges:
1. Verify that the lot number on the control vial and the
assay sheet are the same.
2. Check the expiration date for the test cassette and quality
control materials. Discard expired products.
3. Retest the control level that is out of range using a new
sample from the same control vial. Pay careful attention to
possible errors in technique.
If the control is within acceptable limits, patient samples may be
tested and results reported.
If the control is outside the acceptable limits, retest with a sample of
control from a new vial.
• If results are in range, continue testing patient samples.
• If the control is still outside the acceptable limits, contact
Alere. Do not use the analyzer for testing patient samples
until the problem is resolved.
28 Alere Cholestech LDX
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System User Manual