The need for accurate total cholesterol measurement. Recommended analytical goals, current state of reliability, and guidelines for better determinations.

We have approached a dawn of a new era in detection, evaluation, treatment, and monitoring of individuals with elevated blood cholesterol levels who are at increased risk for CHD. The NHLBI's National Cholesterol Education Program will be the major force underlying this national awareness program, which is dependent on the clinical laboratories providing reliable data. Precision or reproducibility of results is not a problem for most of the laboratories, but accuracy is a major concern. Both the manufacturers and laboratorians need to standardize the measurement for cholesterol so that the accuracy base is traceable to the NCCLS NRS/CHOL. The manufacturers need to adopt a uniform policy that will ensure that the values assigned to calibration, quality control, and quality assurance or survey materials are accurate and traceable to the NCCLS/CHOL. Since, at present, there are some limitations of these materials caused by matrix effects, laboratories are encouraged to use the CDC-NHLBI National Reference Laboratory Network to evaluate and monitor their ability to measure patient blood cholesterol levels accurately. Major areas of analytical problems are identified and general, as well as specific, recommendations are provided to help ensure reliable measurement of cholesterol in patient specimens.