Performance of predispensed reagent and noncentrifugation methods for high-density lipoprotein cholesterol measurement.

Abstract

To evaluate the performance of high-density lipoprotein cholesterol methods with predispensed reagent (SPINPRO, ISO Spin, Vitros, and One Shots) and noncentrifugation separation (Magnetic-HDL) compared with traditional high-density lipoprotein cholesterol methods (PBI Plus, Boehringer-Mannheim, and Abbott). Precision was evaluated by running two concentrations of frozen human sera and two concentrations of lyophilized quality control material according to National Committee for Clinical Laboratory Standards document EP5-T2. Accuracy was evaluated by comparing sample results achieved by each method with those by the Cholesterol Reference Method Laboratory Network Designated Comparison Method and the Lipid Research Clinics' heparin-Mn++ method. Sera from donors with high triglyceride levels were used to challenge the ability of each method to measure lipemic samples for each method. Outpatient clinic and university medical center. Forty-two ambulatory donors with high-density lipoprotein cholesterol levels ranging from 30 to 102 mg/dL, cholesterol levels ranging from 107 to 679 mg/dL, and triglyceride levels ranging from 20 to 2450 mg/dL. Precision, accuracy, linearity, and ability to measure lipemic samples. Imprecision varied from CV 1.4% to 8.6%. The mean absolute bias for each method versus the Designated Comparison Method ranged from 2.6% to 13.3%. Deming regression analysis of all methods versus the heparin-Mn++ method gave slopes from 0.88 to 1.08 and intercepts from -4.5 to 0.0 mg/dL. All methods met the current 22% total error for individual specimens recommended by the National Cholesterol Education Program. Not all methods could measure high-density lipoprotein cholesterol in the presence of high concentrations of triglycerides. Performance of all methods met the current recommendations of the National Cholesterol Education Program. Not all methods met the 1998 performance goals.