title: Analytical and clinical performance of a homogeneous enzymatic LDL-cholesterol assay compared with the ultracentrifugation-dextran sulfate-Mg2+ method.
abstract: LDL-cholesterol (LDL-C) concentration is currently determined in most clinical laboratories by the Friedewald calculation. This approach has several limitations and may not meet the current total error requirement in LDL-C measurement of < or = 12%. We evaluated the analytical and clinical performance of the direct N-geneous LDL-C assay (Equal Diagnostics). The N-geneous method correlated highly with the modified beta-quantification assay (r = 0.95; y = 0.91x + 70.6 mg/L; n = 199), showed no significant effect of increased triglyceride or other common interferants, and performed adequately in serum samples from nonfasting individuals. This assay demonstrated a mean total error of 6.75% over a wide range of LDL-C concentrations. In addition, at the medical decision cutoff points, this LDL-C assay showed positive predictive values of 78-95% and negative predictive values of 84-99%. We conclude that the N-geneous LDL-C meets the currently established analytical performance goals and appears to have a role in the diagnosis and management of hypercholesterolemic patients.
authors.affiliation: Department of Laboratory Medicine, Children's Hospital, Boston, MA 02115, USA. rifai@a1.tch.harvard.edu
authors.forename: N
authors.initials: N
authors.lastname: Rifai
authors.forename: E
authors.initials: E
authors.lastname: Iannotti
authors.forename: K
authors.initials: K
authors.lastname: DeAngelis
authors.forename: T
authors.initials: T
authors.lastname: Law
mesh_terms: D008078:Cholesterol, LDL / Q000097:blood*; D016264:Dextran Sulfate; D004355:Drug Stability; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood; D008274:Magnesium; D019518:Postprandial Period; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D014461:Ultracentrifugation / Q000379:methods
chemical_list: D008078:Cholesterol, LDL; D011933:Reagent Kits, Diagnostic; D016264:Dextran Sulfate; D008274:Magnesium