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Lipids and Lipoproteins |
1
Department of Laboratory Medicine, Children's Hospital, 300 Longwood Ave., Boston, MA 02115.
2
Department of Pathology, Harvard Medical School, Boston,
MA 02115.
a Author for correspondence. Fax 617-355-6081; e-mail rifai{at}a1.tch.harvard.edu.
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 
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.
The following articles in journals at HighWire Press have cited this article:
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  S. Mora, N. Rifai, J. E. Buring, and P. M Ridker Comparison of LDL Cholesterol Concentrations by Friedewald Calculation and Direct Measurement in Relation to Cardiovascular Events in 27 331 Women Clin. Chem., May 1, 2009; 55(5): 888 - 894. [Abstract] [Full Text] [PDF]
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 E. Giovannucci, Y. Liu, B. W. Hollis, and E. B. Rimm 25-Hydroxyvitamin D and Risk of Myocardial Infarction in Men: A Prospective Study Arch Intern Med, June 9, 2008; 168(11): 1174 - 1180. [Abstract] [Full Text] [PDF]
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 T. Wu, W. C. Willett, N. Rifai, and E. B. Rimm Plasma Fluorescent Oxidation Products as Potential Markers of Oxidative Stress for Epidemiologic Studies Am. J. Epidemiol., September 1, 2007; 166(5): 552 - 560. [Abstract] [Full Text] [PDF]
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 S. de Ferranti, D. Shapiro, R. Markowitz, E. Neufeld, N. Rifai, and H. Bernstein Nonfasting Low-Density Lipoprotein Testing: Utility for Cholesterol Screening in Pediatric Primary Care Clinical Pediatrics, June 1, 2007; 46(5): 441 - 445. [Abstract] [PDF]
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 S. Santosa, I. Demonty, A. H. Lichtenstein, K. Cianflone, and P. J.H. Jones An Investigation of Hormone and Lipid Associations after Weight Loss in Women J. Am. Coll. Nutr., June 1, 2007; 26(3): 250 - 258. [Abstract] [Full Text] [PDF]
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F. K. Welty, K. S. Lee, N. S. Lew, and J.-R. Zhou Effect of Soy Nuts on Blood Pressure and Lipid Levels in Hypertensive, Prehypertensive, and Normotensive Postmenopausal Women Arch Intern Med, May 28, 2007; 167(10): 1060 - 1067. [Abstract] [Full Text] [PDF]
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 C. B. Ebbeling, M. M. Leidig, H. A. Feldman, M. M. Lovesky, and D. S. Ludwig Effects of a Low-Glycemic Load vs Low-Fat Diet in Obese Young Adults: A Randomized Trial JAMA, May 16, 2007; 297(19): 2092 - 2102. [Abstract] [Full Text] [PDF]
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 T. Pischon, C. J. Girman, F. M. Sacks, N. Rifai, M. J. Stampfer, and E. B. Rimm Non-High-Density Lipoprotein Cholesterol and Apolipoprotein B in the Prediction of Coronary Heart Disease in Men Circulation, November 29, 2005; 112(22): 3375 - 3383. [Abstract] [Full Text] [PDF]
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 R. P. Peeters, A. W. van den Beld, H. Attalki, H. v. Toor, Y. B. de Rijke, G. G. J. M. Kuiper, S. W. J. Lamberts, J. A. M. J. L. Janssen, A. G. Uitterlinden, and T. J. Visser A new polymorphism in the type II deiodinase gene is associated with circulating thyroid hormone parameters Am J Physiol Endocrinol Metab, July 1, 2005; 289(1): E75 - E81. [Abstract] [Full Text] [PDF]
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 C. B Ebbeling, M. M Leidig, K. B Sinclair, L. G Seger-Shippee, H. A Feldman, and D. S Ludwig Effects of an ad libitum low-glycemic load diet on cardiovascular disease risk factors in obese young adults Am. J. Clinical Nutrition, May 1, 2005; 81(5): 976 - 982. [Abstract] [Full Text] [PDF]
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 E. T. Bairaktari, K. I. Seferiadis, and M. S. Elisaf Evaluation of Methods for the Measurement of Low-Density Lipoprotein Cholesterol Journal of Cardiovascular Pharmacology and Therapeutics, January 1, 2005; 10(1): 45 - 54. [Abstract] [PDF]
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I. Shai, E. B. Rimm, S. E. Hankinson, G. Curhan, J. E. Manson, N. Rifai, M. J. Stampfer, and J. Ma Multivariate Assessment of Lipid Parameters as Predictors of Coronary Heart Disease Among Postmenopausal Women: Potential Implications for Clinical Guidelines Circulation, November 2, 2004; 110(18): 2824 - 2830. [Abstract] [Full Text] [PDF]
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T. Pischon, C. J. Girman, G. S. Hotamisligil, N. Rifai, F. B. Hu, and E. B. Rimm Plasma Adiponectin Levels and Risk of Myocardial Infarction in Men JAMA, April 14, 2004; 291(14): 1730 - 1737. [Abstract] [Full Text] [PDF]
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S. A. Riddler, E. Smit, S. R. Cole, R. Li, J. S. Chmiel, A. Dobs, F. Palella, B. Visscher, R. Evans, and L. A. Kingsley Impact of HIV Infection and HAART on Serum Lipids in Men JAMA, June 11, 2003; 289(22): 2978 - 2982. [Abstract] [Full Text] [PDF]
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S. Usui, H. Kakuuchi, M. Okamoto, Y. Mizukami, and M. Okazaki Differential Reactivity of Two Homogeneous LDL-Cholesterol Methods to LDL and VLDL Subfractions, as Demonstrated by Ultracentrifugation and HPLC Clin. Chem., November 1, 2002; 48(11): 1946 - 1954. [Abstract] [Full Text] [PDF]
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W. G. Miller, P. P. Waymack, F. P. Anderson, S. F. Ethridge, and E. C. Jayne Performance of Four Homogeneous Direct Methods for LDL-Cholesterol Clin. Chem., March 1, 2002; 48(3): 489 - 498. [Abstract] [Full Text] [PDF]
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M. Nauck, G. R. Warnick, and N. Rifai Methods for Measurement of LDL-Cholesterol: A Critical Assessment of Direct Measurement by Homogeneous Assays versus Calculation Clin. Chem., February 1, 2002; 48(2): 236 - 254. [Abstract] [Full Text] [PDF]
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W. Willett, M. Stampfer, N.-F. Chu, D. Spiegelman, M. Holmes, and E. Rimm Assessment of Questionnaire Validity for Measuring Total Fat Intake using Plasma Lipid Levels as Criteria Am. J. Epidemiol., December 15, 2001; 154(12): 1107 - 1112. [Abstract] [Full Text] [PDF]
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B. D. Ragland, R. J. Konrad, C. Chaffin, C. A. Robinson, and R. W. Hardy Evaluation of a Homogeneous Direct LDL-Cholesterol Assay in Diabetic Patients: Effect of Glycemic Control Clin. Chem., November 1, 2000; 46(11): 1848 - 1851. [Full Text] [PDF]
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H. Fei, S. Maeda, H. Kirii, S. Fujigaki, N. Maekawa, H. Fujii, H. Wada, K. Saito, and M. Seishima Evaluation of Two Different Homogeneous Assays for LDL-Cholesterol in Lipoprotein-X-positive Serum Clin. Chem., September 1, 2000; 46(9): 1351 - 1356. [Abstract] [Full Text] [PDF]
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M. Esteban-Salan, A. Guimon-Bardesi, J. M. de la Viuda-Unzueta, M. N. Azcarate-Ania, P. Pascual-Usandizaga, and E. Amoroto-Del-Rio Analytical and Clinical Evaluation of Two Homogeneous Assays for LDL-Cholesterol in Hyperlipidemic Patients Clin. Chem., August 1, 2000; 46(8): 1121 - 1131. [Abstract] [Full Text] [PDF]
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F. Gomez, J. Camps, J. M. Simo, N. Ferre, and J. Joven Agreement Study of Methods Based on the Elimination Principle for the Measurement of LDL- and HDL-Cholesterol Compared with Ultracentrifugation in Patients with Liver Cirrhosis Clin. Chem., August 1, 2000; 46(8): 1188 - 1191. [Full Text] [PDF]
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P. Benlian, C. Cansier, G. Hennache, O. Khallouf, P. Bayer, F. Duron, F. Carrat, R. Couderc, O. Chazouilleres, J. Bardet, et al. Comparison of a New Method for the Direct and Simultaneous Assessment of LDL- and HDL-Cholesterol with Ultracentrifugation and Established Methods Clin. Chem., April 1, 2000; 46(4): 493 - 505. [Abstract] [Full Text] [PDF]
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M. Nauck, M. S. Graziani, D. Bruton, C. Cobbaert, T. G. Cole, F. Lefevre, W. Riesen, P. S. Bachorik, and N. Rifai Analytical and Clinical Performance of a Detergent-based Homogeneous LDL-Cholesterol Assay: A Multicenter Evaluation Clin. Chem., April 1, 2000; 46(4): 506 - 514. [Abstract] [Full Text] [PDF]
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A. Kondo, Y. Muranaka, I. Ohta, and T. Kanno Dynamic Reaction in a Homogeneous HDL-Cholesterol Assay Visualized by Electron Microscopy Clin. Chem., November 1, 1999; 45(11): 1974 - 1980. [Abstract] [Full Text] [PDF]
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