Global Standardization of Lipid/Lipoprotein Testing.

As lipid/lipoprotein research elucidated the mechanism of atherosclerosis, lipid/lipoprotein tests were developed for simple and rapid screening, diagnosis, and management of dyslipidemic patients. In 1988, the Centers of Disease Control and Prevention (CDC) in the United States initiated a global standardization program for lipid/lipoprotein testing through the Cholesterol Reference Measurement Laboratory Network (CRMLN), in which the chemical lipid measurements were adopted as reference measurement procedures (RMPs). In 2010, an American group questioned the accuracy of the direct LDL-C and HDL-C assays, causing a great deal of confusion. Our two comparative studies evaluating the direct LDL-C and HDL-C assays have removed reagents with poor analytical performance from the market and demonstrated that the assays are currently accurate enough for clinical use. Because these traditional chemical methods require a high level of technical expertise, RMP are shifting from chemical reaction-based methods to mass spectrometry-based methods. We are now working on the standardization of lipoprotein(a) using the mass spectrometry-based method as an RMP.