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Clinical Chemistry 43: 816-823, 1997;
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Right arrow Lipids, Lipoproteins, and Cardiovascular Risk Factors
(Clinical Chemistry. 1997;43:816-823.)
© 1997 American Association for Clinical Chemistry, Inc.


Articles

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

Neil Harrisa, Vartouhi Galpchian, Jennifer Thomas, Elizabeth Iannotti, Terence Law and Nader Rifai

Departments of Laboratory Medicine and Pathology, Children's Hospital and Harvard Medical School, Boston, MA 02115.
a Address correspondence to this author, at: Department of Laboratory Medicine, Farley 705, Children's Hospital, 300 Longwood Ave., Boston, MA 02115. Fax 617 355-6081; e-mail harris n{at}a1.tch.harvard.edu

We report on the analytical performance of three generations of HDL-cholesterol assays: phosphotungstic acid/Mg2+, Spinpro®, and a homogeneous method, N-geneousTM. 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.


Key Words: indexing terms: triglycerides • method comparison • performance goals




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