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Articles |
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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