Lack of Agreement of Homogeneous Assays with the Reference Method for Ldl-Cholesterol May Not Indicate Unreliable Prediction of Risk for Cardiovascular Disease (Letters) (Letter to the Editor‪)‬

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.