The clinical impact of assay standardization and traceability: A case study of cholesterol

Abstract

Coronary heart disease (CHD) is the major cause of death internationally, and yet most can be prevented using population-wide strategies by addressing behavioral risk factors, including reduction of blood cholesterol levels. Following the definition of clinical decision limits for cholesterol according to risk of CHD, an international effort was undertaken to establish traceability of routine clinical cholesterol assays to improve reproducibility and accuracy. This task has been achieved through the establishment of the Cholesterol Reference Measurement Laboratory Network. This work is associated with a reduction in the number of persons with elevated cholesterol levels and reduction in the death rates from CHD. It has been a major achievement for the discipline of laboratory medicine and a guide for future efforts for the improvement of patient outcomes.