The Centers for Disease Control-National Heart, Lung and Blood Institute Lipid Standardization Program. An approach to accurate and precise lipid measurements

Abstract

In collaboration with the National Heart, Lung, and Blood Institute, the CDC has supported programs for standardizing lipid measurements for more than 30 years. These programs were begun because comparable and accurate quantitative measurements were needed for epidemiologic studies of coronary heart disease. Since the first program was initiated, over 500 national and international laboratories have participated in the various CDC lipid standardization programs. The cornerstone of these standardization programs has been an accuracy base of lipid reference materials and methods developed by CDC. Specifically, CDC has developed human, serum-based reference materials for cholesterol, HDL, triglyceride, and apolipoproteins A-I and B and reference methods for total cholesterol, HDL, and triglyceride. The CDC reference method for cholesterol has been adopted as the national reference method for cholesterol by the National Reference System for the Clinical Laboratory Council of the National Committee for Clinical Laboratory Standards. The approved CDC reference method along with an approved NBS definitive method, an approved NBS certified Reference Material, and the CDC certified serum-based secondary reference materials make up the accuracy base for serum cholesterol measurements in the United States, and together they are recognized as the National Reference System for Cholesterol. The NCEP Laboratory Standardization Panel recommends that cholesterol measurements made by all clinical laboratories should be standardized so that cholesterol values are traceable to the National Reference System for Cholesterol. In support of the NCEP's efforts, CDC will establish a standardization program permitting the laboratory and manufacturing community to trace cholesterol measurements and the development of cholesterol diagnostic products back to the national reference system. The major emphasis of this standardization effort is to establish a network of reference method laboratories (1) to assign cholesterol values to all commercially prepared lots of calibrators and control materials and (2) to provide reference measurements on individual "fresh" human serum specimens to manufacturers and clinical laboratories. CDC is also working to (1) provide reference materials to manufacturers, (2) collaborate with NBS to maintain documentation of the national reference system accuracy base, (3) cooperate with proficiency testing organizations to assist in the accurate labeling of reference materials, and (4) provide training and education pertinent to cholesterol standardization.(ABSTRACT TRUNCATED AT 400 WORDS)