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Cholesterol--a model system to relate medical needs with analytical performance
1Department of Pathology & Laboratory Medicine, University of Wisconsin, Madison 53792-2472.
Clinical Chemistry
|July 1, 1993
Summary
Cholesterol testing now meets medical needs through established standards and improved analytical performance. This systematic approach ensures accurate lab results and can serve as a model for other diagnostic tests.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Diagnostic Testing
Background:
- Cholesterol testing has evolved significantly.
- Linking medical use to analytical performance is crucial for diagnostic tests.
Purpose of the Study:
- To illustrate a systematic approach for aligning laboratory test performance with medical requirements.
- To highlight the current state of cholesterol testing as a successful model.
Main Methods:
- Establishing a standard diagnostic process (National Cholesterol Education Program).
- Utilizing a readily available reference method for accuracy.
- Improving analytical system precision by manufacturers.
- Setting operating specifications with statistical quality control.
- Monitoring performance via proficiency testing against CLIA '88 standards.
Main Results:
- Laboratories can now perform cholesterol testing with necessary accuracy and precision.
- A robust framework ensures reliable cholesterol measurement.
Conclusions:
- The cholesterol testing model demonstrates a logical, scientific approach.
- This model can be applied to other analytes to ensure analytical performance meets medical needs.