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Reviews |
1
Pacific Biometrics Research Foundation, Issaquah, WA 98027.
2
Department of Clinical Chemistry, University Hospital, 79106 Freiburg, Germany.
3
Departments of Laboratory Medicine and Pathology, Children’s Hospital and Harvard Medical School, Boston, MA 02115.
aAddress correspondence to this author at: Pacific Biometrics Research Foundation, 24415 SE 156 St., Issaquah, WA 98027. Fax 425-392-7680; e-mail grwarnick{at}hotmail.com.
Background: Adoption of automated homogeneous assays for HDL-cholesterol (HDL-C) is increasing, driven by the need of clinical laboratories to cope with increasing workloads while containing costs. However, performance characteristics of homogeneous assays often differ in important aspects from those of the earlier precipitation methods. This review provides an overview of the new generation of homogeneous assays for HDL-C within the historical context of the evolution of methods and the efforts to standardize measurements of the lipoproteins.
Approach: This is a narrative review based on method evaluations conducted in the laboratories of the authors as well as on relevant publications, especially comparative evaluation studies, from the literature. Publications considered here have been collected by the authors over the past 30 years of involvement as methods for HDL-C made the transition from their early use in lipid research laboratories to clinical laboratories and the recent emergence of homogeneous assays.
Content: The presentation includes descriptions of methodologies, including homogeneous, precipitation, electrophoresis, and ultracentrifugation assays. Reference methods and recommended approaches for assessing accuracy are described. Accuracy and imprecision are summarized in the context of the National Cholesterol Education Program (NCEP) standards for analytical performance. The effects of interfering substances and preanalytical sources of variation are presented.
Summary: Homogeneous assays have been shown to be reasonably well suited for use in routine clinical laboratories, generally meeting the NCEP criteria for precision, accuracy, and total error. However, discrepant results compared with the reference methods have been observed with some of the assays, and the sources of discrepancies are not well characterized. Some homogeneous reagents have not been thoroughly evaluated. At least three of the reagents have experienced successive adjustments in formulation; hence, the reagents may not yet be fully optimized. For these reasons, the homogeneous assays cannot be confidently recommended for use in long-term clinical trials and other research applications without thorough validation.
The following articles in journals at HighWire Press have cited this article:
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  V. Charlton-Menys, D. J. Betteridge, H. Colhoun, J. Fuller, M. France, G. A. Hitman, S. J. Livingstone, H. A. W. Neil, C. B. Newman, M. Szarek, et al. Targets of Statin Therapy: LDL Cholesterol, Non-HDL Cholesterol, and Apolipoprotein B in Type 2 Diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS) Clin. Chem., March 1, 2009; 55(3): 473 - 480. [Abstract] [Full Text] [PDF]
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R. Movva and D. J. Rader Laboratory Assessment of HDL Heterogeneity and Function Clin. Chem., May 1, 2008; 54(5): 788 - 800. [Abstract] [Full Text] [PDF]
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 S. E. Borggreve, H. L. Hillege, G. M. Dallinga-Thie, P. E. de Jong, B. H.R. Wolffenbuttel, D. E. Grobbee, A. van Tol, R. P.F. Dullaart, and on behalf of the PREVEND Study Group High plasma cholesteryl ester transfer protein levels may favour reduced incidence of cardiovascular events in men with low triglycerides Eur. Heart J., April 4, 2007; (2007) ehm062v1. [Abstract] [Full Text] [PDF]
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 S. E. Borggreve, H. L. Hillege, B. H. R. Wolffenbuttel, P. E. de Jong, S. J. L. Bakker, G. van der Steege, A. van Tol, R. P. F. Dullaart, and on behalf of the PREVEND Study Group The Effect of Cholesteryl Ester Transfer Protein -629C->A Promoter Polymorphism on High-Density Lipoprotein Cholesterol Is Dependent on Serum Triglycerides J. Clin. Endocrinol. Metab., July 1, 2005; 90(7): 4198 - 4204. [Abstract] [Full Text] [PDF]
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D. J. Blom, F. H. O'Neill, and A. D. Marais Screening for Dysbetalipoproteinemia by Plasma Cholesterol and Apolipoprotein B Concentrations Clin. Chem., May 1, 2005; 51(5): 904 - 907. [Full Text] [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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N. Rifai, G. R. Cooper, W. V. Brown, W. Friedewald, R. J. Havel, G. L. Myers, and G. R. Warnick Clinical Chemistry Journal Has Contributed to Progress in Lipid and Lipoprotein Testing for Fifty Years Clin. Chem., October 1, 2004; 50(10): 1861 - 1870. [Full Text] [PDF]
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E. S. Lima and R. C. Maranhao Rapid, Simple Laser-Light-Scattering Method for HDL Particle Sizing in Whole Plasma Clin. Chem., June 1, 2004; 50(6): 1086 - 1088. [Full Text] [PDF]
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N. Kadri, P. Douville, and P. Lachance Monoclonal Paraprotein May Interfere with the Roche Direct HDL-C Plus Assay Clin. Chem., June 1, 2002; 48(6): 964 - 964. [Full Text] [PDF]
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T. G. Cole, W. L. Nowatzke, C. L. Bisgaier, and B. R. Krause Method-dependent Changes in ""HDL-Cholesterol"" with Recombinant Apolipoprotein A-IMilano Infusion in Healthy Volunteers Clin. Chem., April 1, 2002; 48(4): 680 - 681. [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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G. R. Warnick, G. L. Myers, G. R. Cooper, and N. Rifai Impact of the Third Cholesterol Report from the Adult Treatment Panel of the National Cholesterol Education Program on the Clinical Laboratory Clin. Chem., January 1, 2002; 48(1): 11 - 17. [Abstract] [Full Text] [PDF]
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