Performance of predispensed reagent and noncentrifugation methods for high-density lipoprotein cholesterol measurement
Zhang, D.J.; LaRue, S.; Miller, W.G.; Cole, T.G.
Archives of Pathology and Laboratory Medicine 121(9): 938-947
1997
ISSN/ISBN: 0003-9985 PMID: 9302925 Document Number: 478035
Objective.- 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). Design.- 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. Setting.- Outpatient clinic and university medical center. Patients.- 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. Main Outcome Measure.- Precision, accuracy, linearity, and ability to measure lipemic samples. Results.- 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. Conclusions.- Performance of all methods met the current recommendations of the National Cholesterol Education Program. Not all methods met the 1998 performance goals.