Regional interlaboratory standardization of determinations of cholesterol, high-density lipoprotein cholesterol, and triglycerides

The Clinical Chemistry Forum of Central Virginia initiated a lipid standardization program to help ensure that its members meet the current National Cholesterol Education Program guidelines for cholesterol testing, and to standardize assays of high-density lipoprotein (HDL) cholesterol and triglycerides so as to provide accurate lipid profiles. We found that freshly collected, never-frozen human sera must be used to assess interlaboratory accuracy for cholesterol, HDL cholesterol, and triglycerides assays, and that at least 23 samples are required to detect a 3% bias with 90% power when the between-laboratory imprecision (CV) is 3%. After recalibration, all 12 laboratories had a mean cholesterol bias ≤5%, nine of 10 laboratories had a mean HDL cholesterol bias ≤40 mg/L for samples with values ≤570 mg/L, and 10 of 12 laboratories had a mean triglycerides bias ≤10% for fresh human sera split between participants and the Centers for Disease Control. Pools of frozen human serum were shown to have matrix biases >3% for cholesterol in seven of 11 laboratories, and >40 mg/L for HDL cholesterol in six of nine laboratories.