Three generations of high-density lipoprotein cholesterol assays compared with ultracentrifugation/dextran sulfate–Mg2+ method

Abstract

AbstractWe report on the analytical performance of three generations of HDL-cholesterol assays: phosphotungstic acid/Mg2+, Spinpro®, and a homogeneous method, N-geneous™. The run-to-run imprecision (CV) of all assays was ≤4.9%, and all results correlated highly with those of a modified reference procedure (r ≥0.96). At triglycerides concentrations <4000 mg/L, these field methods showed an acceptable systematic error (y = 1.12x − 47, 1.05x − 23, and 0.96x + 8 for the phosphotungstate, Spinpro, and N-geneous assays, respectively), and the total error of the field methods met the current National Cholesterol Education Program (NCEP) performance goal of ≤22%. Regression analyses of results for samples with triglycerides >4000 mg/L produced the following results for the above respective assays: y = 1.08x − 4.2, 1.02x + 3.6, and 0.85x + 108. In this hypertriglyceridemic group, only the N-geneous assay (at an HDL-cholesterol content of 240 mg/L) had a total error (35%) that exceeded the NCEP limit. Bilirubin and ascorbate produced a negative interference with the phosphotungstate and Spinpro assays but had little effect on the N-geneous assay.