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

Background: Accurate high-density lipoprotein cholesterol (HDL-C) measurements are important for management of cardiovascular diseases. The US Centers for Disease Control and Prevention (CDC) and Cholesterol Reference Method Laboratory Network (CRMLN) perform ultracentrifugation (UC) reference measurement procedure (RMP) to value assign HDL-C. Japanese CRMLN laboratory (Osaka) concurrently runs UC procedure and the designated comparison method (DCM). Osaka performance of UC and DCM was examined and compared with CDC RMP. Methods: CDC RMP involved UC, heparin-MnCl₂ precipitation, and cholesterol analysis. CRMLN DCM for samples containing <200mg/dl triglycerides involved 50-kDa dextran sulfate-MgCl₂ precipitation and cholesterol determination. Results: HDL-C regression equations obtained with CDC (x) and Osaka (y) were y=0.992x+0.542 (R²=0.996) for Osaka UC and y=1.004x-0.181 (R²=0.998) for DCM. Pass rates within ±1mg/dl of the CDC target value were 91.9 and 92.1% for Osaka UC and DCM, respectively. Biases at 40mg/dl HDL-C were +0.22 and -0.02mg/dl for Osaka UC and DCM, respectively. Conclusions: Osaka UC and DCM were highly accurate, precise, and stable for many years, assisting manufacturers to calibrate products for clinical laboratories to accurately measure HDL-C for patients, calculate non-HDL-C, and estimate low-density lipoprotein cholesterol with the Friedewald equation.