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Lack of Agreement of Homogeneous Assays with the Reference Method for LDL-Cholesterol May Not Indicate Unreliable Prediction of Risk for Cardiovascular Disease

Pacific Biometrics Research Foundation, 24415 SE 156 St., Issaquah, WA 98027, E-mail grwarnick@hotmail.com

The first 300 words of the full text of this article appear below.

To the Editor:

The recent evaluation of four homogeneous methods for LDL-cholesterol (LDL-C) by Miller et al. (1) appropriately concludes that the methods do not meet the analytical performance goals of the National Cholesterol Education Program (NCEP) because of excessive deviation from the Reference Method (RM) in the tested samples. The comparison method in this study, the accepted RM for LDL-C, was performed at the CDC, considered the "gold standard" in lipid/lipoprotein testing. Although the study was well designed and the conclusions were certainly supported by the reported observations in the context of current thought about accuracy in lipoprotein testing, an important issue is raised concerning the balance between standardization and innovation.

Standardization of results is considered to be especially important with the lipid and lipoprotein analytes because national cutpoints have been set by expert panels based on cardiovascular disease (CVD) risk relationships and population distributions from large epidemiology studies (2). The CDC, charged with standardizing the research laboratories, developed RMs using techniques derived from the early research methodologies. Subsequently, an expert panel convened by the NCEP recommended that the CDC RMs be continued for standardization of routine laboratories (3). Other analytical methods demonstrated to give acceptable agreement with the RMs can not only be reasonably assured of reliable patient classification based on the recommended cutpoints, but can also relate to the extensive base of research using standardized methods. Nevertheless, although the RMs were chosen by a consensus process, are widely accepted, and have been useful for years in standardizing both research and routine measurements, they have not been demonstrated to provide optimum selection of lipoprotein particles in predicting CVD risk. A possible unfortunate consequence of the emphasis on accuracy and standardization of results in lipoprotein measurement might be to discourage innovation in developing new and improved . . . [Full Text of this Article]

W. Greg Miller^1a, Parvin P. Waymack² and F. Philip Anderson¹

¹ Department of Pathology, Virginia Commonwealth University, Health System, Richmond, VA 23298

² CDC, National Center for Environmental Health, Division of Laboratory Sciences, Sepcial Activities Branch, Atlanta, GA 30341

^aAuthor for correspondence.

The following articles in journals at HighWire Press have cited this article:

				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]