Quality of lipid and lipoprotein measurements in community laboratories

Objective.-To determine the reliability of cholesterol and lipoprotein measurements conducted in local community laboratories. Methods.-Standardized duplicate serum aliquots at three concentrations (low, intermediate, and high) of total cholesterol, triglycerides, and high-density lipoprotein cholesterol were sent to 21 laboratories used by the physicians participating in the Cholesterol-Lowering Intervention Program. Results obtained from the laboratories were compared with values obtained from the Centers for Disease Control and Prevention-standardized Heinz Lipid Laboratory and with the means of the entire sample. Results.-The mean coefficient of variation (CV) was 1.3% or less for all three levels of total cholesterol, which demonstrates a high degree of precision. Accuracy was also high; over 80% of all laboratories were within 5% of the Heinz Laboratory low reference value, and all were within the 5% range for the medium and high samples. The CVs for triglycerides (<2.3%) and high-density lipoprotein cholesterol (<2.2%) were similar to that for total cholesterol, but up to 56% and 61% of the values fell outside the Heinz reference range for high-density lipoprotein cholesterol (intermediate concentration) and triglycerides (low concentration), respectively. As the Heinz Laboratory has a negative 2.7% bias versus the Centers for Disease Control and Prevention for total cholesterol and high-density lipoprotein cholesterol measurements, a higher percentage of laboratories fell outside the Centers for Disease Control and Prevention range. For medium and high total cholesterol samples, 16% of the laboratories were outside the 5% Centers for Disease Control and Prevention range, and the value was 58% for the low total cholesterol sample. For high-density lipoprotein cholesterol the percentages were 61%, 56%, and 39% for the low, medium, and high samples, respectively. Conclusions.-These data suggest that according to the standards set by the National Cholesterol Education Program Laboratory Standardization Panel, reliability of total cholesterol measurements in local laboratories is high. Lower levels of accuracy were noted for triglycerides and high-density lipoprotein cholesterol measurements. (Arch Pathol Lab Med. 1997;121:105-109)