HDL cholesterol performance using an ultracentrifugation reference measurement procedure and the designated...

Area of Science:

• Clinical Chemistry
• Cardiovascular Disease Biomarkers
• Laboratory Medicine

Background:

• Accurate high-density lipoprotein cholesterol (HDL-C) measurements are essential for cardiovascular disease management.
• The US Centers for Disease Control and Prevention (CDC) and Cholesterol Reference Method Laboratory Network (CRMLN) utilize ultracentrifugation (UC) for HDL-C reference measurements.
• The Japanese CRMLN laboratory in Osaka concurrently employs UC and a designated comparison method (DCM) for HDL-C analysis.

Purpose of the Study:

• To evaluate the performance of the Osaka CRMLN laboratory's UC and DCM procedures for HDL-C measurement.
• To compare the Osaka laboratory's results with the CDC's RMP (reference measurement procedure).
• To ensure accurate HDL-C calibration for clinical laboratory products.

Main Methods:

• The CDC RMP involved UC, heparin-MnCl₂ precipitation, and cholesterol analysis.
• The CRMLN DCM utilized 50-kDa dextran sulfate-MgCl₂ precipitation for samples with <200 mg/dl triglycerides, followed by cholesterol determination.
• Comparison of Osaka's UC and DCM results against CDC RMP data.

Main Results:

• Regression analysis showed high correlation between Osaka and CDC methods (R² > 0.996).
• Pass rates within ±1 mg/dl of the CDC target value were high for both Osaka UC (91.9%) and DCM (92.1%).
• Biases at 40 mg/dl HDL-C were minimal for Osaka UC (+0.22 mg/dl) and DCM (-0.02 mg/dl).

Conclusions:

• The Osaka UC and DCM methods exhibit high accuracy, precision, and long-term stability.
• These validated methods support manufacturers in calibrating clinical laboratory assays for accurate HDL-C measurement.
• Accurate HDL-C measurements facilitate patient care, non-HDL-C calculation, and LDL-C estimation using the Friedewald equation.