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1
Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA 30341-3724.
2
Pacific Biometrics Research Foundation, Seattle, WA
98119.
3
Core Laboratory for Clinical Studies, Washington
University School of Medicine, St. Louis, MO 63110.
4
David Hassemer (State Laboratory of Hygiene, Madison,
WI); Santica Marcovina (Northwest Lipid Research Laboratories,
Department of Medicine, University of Washington, Seattle, WA); Robert
Rej (Wadsworth Center for Laboratories and Research, New York State
Department of Health, Albany, NY); Thomas G. Cole (Core Laboratory for
Clinical Studies, Washington University School of Medicine, St. Louis,
MO); Elizabeth T. Leary (Pacific Biometrics Research Foundation,
Seattle, WA); Christa M. Boersma-Cobbaert (Lipid Reference Laboratory,
Department of Clinical Chemistry, University of Rotterdam, Rotterdam,
The Netherlands); Masakazu Nakamura (Osaka Medical Center for Cancer
and Cardiovascular Diseases, Osaka, Japan); Chris J. Packard (Institute
of Biochemistry, Glasgow Royal Infirmary, Glasgow, Scotland); David W.
Seccombe [Canadian Reference Laboratory (1996) Ltd., Vancouver,
Canada]; Ferruccio Ceriotti (Laboratorio Analisi Cliniche, H.S.
Raffaele, Milan, Italy). Inactive laboratories that also participated
in the study: John H. Eckfeldt (Department of Laboratory Medicine and
Pathology, University of Minnesota Hospital and Clinic, Minneapolis,
MN); Joan A. Waletzky (Department of Biochemistry, The Cleveland Clinic
Foundation, Cleveland, OH); Judith R. McNamara (Jean Mayer USDA Human
Nutrition Research Center on Aging at Tufts University, Boston, MA).
a Address correspondence to this author at: Centers for Disease Control and Prevention, Mailstop F25, 4770 Buford Hwy. NE, Atlanta, GA 30341-3724. Fax 770-488-4192; e-mail mmk1{at}cdc.gov
Background: Accurate and precise HDL-cholesterol (HDL-C) measurements are essential for effective application of National Cholesterol Education Program treatment guidelines. The Cholesterol Reference Method Laboratory Network (CRMLN) assists manufacturers of in vitro diagnostic products to establish traceability to the accuracy base. CRMLN sought to implement a designated comparison method (DCM) that overcomes the impracticalities of the expensive and labor-intensive reference method for HDL-C.
Methods: CRMLN evaluated candidate DCMs and selected one that uses 50-kDa dextran sulfate with magnesium ions as the precipitation reagent followed by measurement of cholesterol by the CDC reference method. After validating the method, we transferred it to all CRMLN laboratories and successfully standardized it using CDC frozen serum reference materials. CRMLN laboratories participate in monthly performance evaluations.
Results: CRMLN laboratories were able to meet a precision goal,
as indicated by SD, of 
0.03 mmol/L (1 mg/dL) 94.4% of the time. They
were able to meet a bias goal of 0.05 mmol/L (2 mg/dL) for HDL-C
<1.09 mmol/L (42 mg/dL) 97.3% of the time and a goal of 3% for
HDL-C 
1.09 mmol/L (42 mg/dL) 95.6% of the time. CRMLN is working to
further improve its performance by implementing a bias criterion of
0.03 mmol/L (1 mg/dL) for all HDL-C concentrations.
Conclusions: CRMLN selected, validated, standardized, and implemented a DCM for HDL-C that is accurate, robust, transferable, and practical. The DCM is being used to assist manufacturers in calibrating their products so that ultimately, clinical laboratories using the products will more accurately measure HDL-C.
The following articles in journals at HighWire Press have cited this article:
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  M. S. Yee, D. V. Pavitt, T. Tan, S. Venkatesan, I. F. Godsland, W. Richmond, and D. G. Johnston Lipoprotein separation in a novel iodixanol density gradient, for composition, density, and phenotype analysis J. Lipid Res., June 1, 2008; 49(6): 1364 - 1371. [Abstract] [Full Text] [PDF]
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 G. L. Vega, M. F. Weiner, A. M. Lipton, K. von Bergmann, D. Lutjohann, C. Moore, and D. Svetlik Reduction in Levels of 24S-Hydroxycholesterol by Statin Treatment in Patients With Alzheimer Disease Arch Neurol, April 1, 2003; 60(4): 510 - 515. [Abstract] [Full Text] [PDF]
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 S Houterman, W. Verschuren, C. Oomen, C. Boersma-Cobbaert, and D Kromhout Trends in total and high density lipoprotein cholesterol and their determinants in The Netherlands between 1993 and 1997 Int. J. Epidemiol., October 1, 2001; 30(5): 1063 - 1070. [Abstract] [Full Text] [PDF]
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 G. R. Warnick, M. Nauck, and N. Rifai Evolution of Methods for Measurement of HDL-Cholesterol: From Ultracentrifugation to Homogeneous Assays Clin. Chem., September 1, 2001; 47(9): 1579 - 1596. [Abstract] [Full Text] [PDF]
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M. M. Muller Implementation of Reference Systems in Laboratory Medicine Clin. Chem., December 1, 2000; 46(12): 1907 - 1909. [Full Text] [PDF]
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G. L. Myers, M. M. Kimberly, P. P. Waymack, S. J. Smith, G. R. Cooper, and E. J. Sampson A Reference Method Laboratory Network for Cholesterol: A Model for Standardization and Improvement of Clinical Laboratory Measurements Clin. Chem., November 1, 2000; 46(11): 1762 - 1772. [Abstract] [Full Text] [PDF]
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C. M. Cobbaert and T. K. J. Luderer Total Error Evaluation of Roche Direct HDL-Cholesterol Reagent and Calibrator across 31 Lot Combinations: A 2-Year Experience Clin. Chem., January 1, 2000; 46(1): 133 - 134. [Full Text] [PDF]
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