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Cell-free Biochemical Fluorometric Enzymatic Assay for High-throughput Measurement of Lipid Peroxidation in High Density Lipoprotein
Published on: October 12, 2017
Selection, validation, standardization, and performance of a designated comparison method for HDL-cholesterol for use
M M Kimberly1, E T Leary, T G Cole
1Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA 30341-3724, USA. mmk1@cdc.gov
Clinical Chemistry
|October 3, 1999
Summary
The Cholesterol Reference Method Laboratory Network (CRMLN) developed a practical method for accurate high-density lipoprotein cholesterol (HDL-C) measurement. This new method helps standardize diagnostic tests for better patient care.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Diagnostic Assays
Background:
- Accurate high-density lipoprotein cholesterol (HDL-C) measurement is crucial for cardiovascular disease risk assessment and treatment decisions.
- The Cholesterol Reference Method Laboratory Network (CRMLN) aims to improve the accuracy of HDL-C testing by establishing traceability to a reference standard.
- Existing reference methods for HDL-C are costly and labor-intensive, necessitating a more practical approach.
Purpose of the Study:
- To implement a Designated Comparison Method (DCM) for HDL-C that is accurate, precise, and practical.
- To overcome the limitations of the current expensive and labor-intensive reference method for HDL-C.
- To assist in vitro diagnostic manufacturers in standardizing their HDL-C measurement assays.
Main Methods:
- CRMLN evaluated and selected a DCM utilizing dextran sulfate and magnesium ions for HDL-C precipitation.
- The selected method was validated and standardized across all CRMLN laboratories using CDC reference materials.
- Ongoing monthly performance evaluations ensure continued accuracy and precision.
Main Results:
- CRMLN laboratories achieved high precision, meeting a standard deviation goal of ≤0.03 mmol/L (1 mg/dL) 94.4% of the time.
- Bias goals were met for most measurements: ≤0.05 mmol/L (2 mg/dL) for HDL-C <1.09 mmol/L (42 mg/dL) in 97.3% of cases, and ≤3% for HDL-C ≥1.09 mmol/L (42 mg/dL) in 95.6% of cases.
- Performance improvements are ongoing, with a planned bias criterion of 0.03 mmol/L (1 mg/dL) for all HDL-C concentrations.
Conclusions:
- CRMLN successfully implemented an accurate, robust, transferable, and practical DCM for HDL-C measurement.
- This DCM aids manufacturers in calibrating their diagnostic products.
- The ultimate goal is to enable clinical laboratories to achieve more accurate HDL-C measurements for improved patient management.
