Cholestech LDX - 3.2 Quality Control Materials; 3.3 Frequency of Testing

18 QUALITY CONTROL
Cholestech LDX System Procedure Manual
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Recommended Optional Information
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3.1 Introduction
Quality control is the specific set of laboratory activities designed to ensure that the test
system is working properly and that test results satisfy quality standards. Quality control data
must be kept as permanent records to document the performance of laboratory testing.
Documentation includes written laboratory records that are a clear and up-to-date
compilation of quality control data. These records may be in the form of daily worksheets
or logs. The person performing the test should sign and date the log sheets.
We have provided you with a Quality Control Log that you can duplicate and use for recording
quality control test results for the Cholestech LDX System. As an alternative, we have also
supplied a Daily Quality Assurance Record that can be used to record all routine quality
control documentation. The originals are in the
Master Forms section of this manual.
3.2 Quality Control Materials
Control materials should be provided for at least two levels of total cholesterol, HDL
cholesterol, triglycerides, glucose and ALT.
Choice of Material
The preferred quality control material for use with the Cholestech LDX System is
Cholestech LDX Level 1 and Level 2 Control Materials. If you choose to use an alternate
quality control material, see Section 3.2.
Handling of Material
• Follow the instructions for preparation, handling and storage that accompany each lot
of control material.
• Check the expiration date before use. Do not use the control material beyond the
expiration date.
• Mix quality control material by gentle inversion 7–8 times before use.
• Check the control assay sheet for the correct sample setting for running controls.
• Verify that the lot number on the control vial and the assay sheet are the same.
3.3 Frequency of Testing
Liquid Level 1 and Level 2 Controls are available from Cholestech. Controls must
be tested:
• With each new shipment of cassettes (even if cassettes are from the same lot
previously received).
• With each new lot of cassettes.
• As otherwise required by your laboratory’s standard quality control procedures.
• If you are not running the Cholestech LDX under CLIA-waived status, or if your local or
state regulations require more frequent testing of quality control material, then quality
control must be performed in compliance with those regulations.
Quality Control
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