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Published on: November 10, 2017
Measurement of cholesterol and other lipoprotein constituents in the clinical laboratory
1Pacific Biomedrics Research Foundation, Issaquah, WA 98027, USA.
Insights
Accurate lipid and lipoprotein measurements are crucial for predicting cardiovascular disease risk. Standardized laboratory methods and improved assays enhance diagnostic reliability for coronary artery disease management.
Area of Science:
- Clinical Chemistry
- Cardiovascular Diagnostics
- Laboratory Medicine
Background:
- Lipid and lipoprotein measurements are vital for predicting cardiovascular diseases, particularly coronary artery disease (CAD).
- National guidelines, like the National Cholesterol Education Program (NCEP), establish risk assessment and therapeutic strategies using lipid analytes.
- CAD is a major health concern, necessitating reliable diagnostic tools.
Purpose of the Study:
- To review the importance of lipid and lipoprotein measurements in clinical laboratories for cardiovascular disease risk assessment.
- To discuss the development and impact of national guidelines and standardization efforts on lipid testing.
- To highlight recent advancements in analytical methods and their implications for diagnostic accuracy.
Main Methods:
- Review of national consensus guidelines and expert panel recommendations for lipid and lipoprotein testing.
- Discussion of reference methods established by regulatory bodies like the CDC.
- Examination of advancements in automated assays and standardization programs.
Main Results:
- Lipid analytes (total cholesterol, LDL-C, triglycerides, HDL-C) are key indicators for CAD risk.
- Standardization initiatives and reference methods improve the accuracy and traceability of lipid measurements.
- Recent improvements in analytical methods and automated assays offer enhanced precision and cost-effectiveness.
Conclusions:
- Standardized and accurate lipid and lipoprotein testing is essential for effective cardiovascular disease risk management.
- Continued advancements in laboratory methods and adherence to guidelines improve patient diagnosis and treatment.
- Addressing pre-analytical variations is critical for reliable patient classification and clinical decision-making.
Abstract:
Measurements of lipids and lipoproteins in the clinical laboratory have become increasingly important because of their predictive association with cardiovascular diseases, especially coronary artery disease. The US National Institutes of Health-sponsored National Cholesterol Education Program and counterparts in other countries have developed national consensus guidelines for diagnosis and treatment of coronary artery disease which provide risk cut-points and define use of the lipid/lipoprotein analytes in case finding and therapy. Total and low density lipoprotein cholesterol and triglycerides are measured as positive risk factors and high density lipoprotein cholesterol as an inverse risk factor for coronary artery disease. A National Cholesterol Education Program-sponsored expert laboratory panel has developed guidelines for measurements with requisite analytical performance targets for total error and corresponding precision and bias. The US Centers for Disease Control and Prevention have established reference methods for total and high density lipoprotein cholesterol and for triglycerides, with a method for low density lipoprotein cholesterol in development. Standardization programs for research laboratories and a Cholesterol Reference Method Laboratory Network for diagnostic manufacturers and clinical laboratories provide reliable access and documentation of traceability to accepted reference methods. Methods for the lipid/lipoprotein analytes have improved dramatically in recent years and, coupled with improved chemistry analyzer systems and more attention to standardization by manufacturers, offer considerable improvement in analytical performance. Fully automated homogeneous assays for high density lipoprotein cholesterol and newer similar assays for low-density lipoprotein cholesterol have potential for better precision as well as more convenient and cost-effective measurements. Attention to pre-analytical sources of variation is also important in making reliable classification of patients.
