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Published on: October 12, 2017
Quality specifications and the assessment of the biochemical risk of atherosclerosis
Nader Rifai1, G Russell Warnick
1Children's Hospital, Boston, MA 02115, USA. ader.rifai@tch.harvard.edu
Insights
Accurate measurement of cholesterol and C-reactive protein (CRP) is crucial for assessing coronary heart disease (CHD) risk. Quality specifications are set for LDL-C and CRP assays to ensure reliable clinical practice.
Area of Science:
- Clinical Chemistry
- Biochemical Markers
- Cardiovascular Disease Risk Assessment
Background:
- Coronary heart disease (CHD) is a leading cause of mortality globally.
- Biochemical markers are essential for identifying individuals at increased risk of CHD.
- Recommended markers include cholesterol (total, LDL, HDL), triglycerides, and C-reactive protein (CRP).
Purpose of the Study:
- Establish specific performance goals for lipid markers and CRP measurements.
- Address pre-analytical and analytical factors impacting measurement quality.
- Ensure reliable risk assessment in routine clinical practice.
Main Methods:
- Defined quality specifications for low-density lipoprotein cholesterol (LDL-C) and CRP.
- Considered pre-analytical and analytical variables affecting assay performance.
- Evaluated measurement quality targets for routine clinical laboratory assays.
Main Results:
- Target quality for LDL-C reference method: CV ≤4%, bias ≤4%.
- CRP measurement target: total imprecision <10% across the linear range.
- Analytical sensitivity for CRP allows reliable measurement below 0.3 mg/L.
Conclusions:
- National guidelines exist for LDL-C measurement, but routine method performance needs further study.
- Guidelines for CRP measurement are anticipated as more data become available.
- Ensuring assay quality is vital for accurate CHD risk stratification.
Background:
Coronary heart disease (CHD) is the major cause of death in the western world and biochemical markers have been used to identify those individuals who are at increased risk. Although numerous markers have been considered, only total, low-density lipoprotein (LDL), and high-density lipoprotein cholesterol, triglyceride and C-reactive protein (CRP) have been recommended for assessing CHD risk in routine clinical practice.
Methods:
Specific performance goals have been established for the lipid markers and for the measurement of CRP considering both some significant pre-analytical and analytical issues which could affect the quality of their measurements.
Results:
The target for quality specifications for LDL-C with the reference method are CV < or =4% and bias < or =4%. Regarding the measurement of CRP, total imprecision should be <10% across the linear range of the assay and the analytical sensitivity may allow a reliable measurement at values lower than 0.3 mg/l.
Conclusions:
Although national guidelines do exist for LDL-C measurement, additional studies are needed to better characterize the performances of routine methods. As more data are available for CRP, guidelines for its measurement will be soon developed.
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