Recommendations for Improving Cholesterol Measurement: Executive Summary: A Report From the Laboratory Standardization Panel of the National Education Program

In November 1985 the National Cholesterol Education Program (NCEP) was launched with the goal of reducing the prevalence of elevated blood cholesterol in the United States and thereby contribute to reducing the incidence of coronary heart disease (CHD). This program was based on convincing scientific evidence showing that elevated cholesterol (and associated increased low-density lipoprotein cholesterol levels) is associated with increased risk of CHD. Studies also have shown that reducing cholesterol levels reduces the incidence of CHD. A Laboratory Standardization Panel was formed as part of the NCEP so laboratories could provide the same degree of accuracy and precision in measuring cholesterol levels as the Lipid Research Clinic laboratories. As ASCP representative, I served on this panel, which has made recommendations to laboratories and manufacturers in an attempt to provide optimal cholesterol standardization and measurement. The full report addresses the need for reliable measurements with current performance update and analytical performance specifications. The report also addresses preanalytical factors that include biological and other factors altering cholesterol levels. Analytical issues are then dealt with, including methods, reagents, instruments, calibration, quality control, matrix effects, and desk top analyzers.