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Articles |
1
University Hospital Freiburg, Department of Clinical Chemistry, D-79106 Freiburg, Germany.
2
Laboratorio Chimica Clinica, Verona 37126,
Italy.
3
Evaluation Department, Roche Diagnostics, Indianapolis,
IN 46250.
4
Academic Hospital Rotterdam, Department of Clinical
Chemistry, Lipid Reference Laboratory, 3015 GD Rotterdam, The
Netherlands.
5
Washington University School of Medicine, Core
Laboratory for Clinical Studies, St. Louis, MO 63110.
6
Hôpital Robert Debré, Laboratoire Central de
Biochimie, Reims 51092, France.
7
Institut für Klinische Chemie und
Hämatologie des Kantons St. Gallen, St. Gallen 9001,
Switzerland.
8
The Johns Hopkins University School of Medicine,
Baltimore, MD 21205.
9
Childrens’s Hospital and Harvard Medical School,
Department of Laboratory Medicine, Boston, MA 02115.
a Address correspondence to this author at: University Medical Center Freiburg, Department of Clinical Chemistry, Hugstetter Strasse 55, D-79106 Freiburg i. Br., Germany. Fax 49-761-270-3444; e-mail manauck{at}med1.ukl.uni-freiburg.de
Background: LDL-cholesterol (LDL-C) concentrations
currently are determined in most clinical laboratories using the
Friedewald calculation. This approach has several limitations and may
not always meet the current total error recommendation in LDL-C
measurement of 
12% established by the National Cholesterol Education
Program.
Methods: In a multicenter study, we evaluated the analytical and clinical performance of a homogeneous LDL-C assay (LDL-CRoche; Roche Diagnostics, Indianapolis, IN) in a comparison with a ß-quantification method.
Results: This direct assay correlated highly with a ß-quantification method (r = 0.968; y = 1.037x - 95.8 mg/L; n = 355; 95% confidence intervals, 1.011–1.063 for the slope and -129.5 to 62.0 mg/L for the y-intercept) and met the current total error requirement. The assay was not affected significantly by concentrations of hemoglobin up to 6000 mg/L or bilirubin up to 500 mg/L. However, a negative bias of 10% was seen when triglyceride concentrations exceeded 10 000 mg/L. At the medical decision cut-point range, the LDL-CRoche assay showed positive predictive values of 91–100% and negative predictive values of 80–99%. Furthermore, the clinical utility of the assay seemed unaffected in samples obtained postprandially.
Conclusions: The homogeneous LDL-CRoche assay meets the currently established analytical performance goals and may be useful for the diagnosis and management of hyperlipidemic patients.
The following articles in journals at HighWire Press have cited this article:
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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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 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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J. Ordonez-Llanos, A. M. Wagner, R. Bonet-Marques, J. L. Sanchez-Quesada, F. Blanco-Vaca, and F. Gonzalez-Sastre Which Cholesterol Are We Measuring with the Roche Direct, Homogeneous LDL-C Plus Assay? Clin. Chem., January 1, 2001; 47(1): 124 - 126. [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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D. Furuya, A. Yagihashi, S. Nasu, T. Endoh, T. Nakamura, R. Kaneko, C. Kamagata, D. Kobayashi, and N. Watanabe LDL Particle Size by Gradient-Gel Electrophoresis Cannot Be Estimated by LDL-Cholesterol/Apolipoprotein B Ratios Clin. Chem., August 1, 2000; 46(8): 1202 - 1203. [Full Text] [PDF]
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