Elizabeth T. Leary, PhD, Chief Scientific Officer at Pacific Biomarkers, Inc. (PBI), a provider of biomarker laboratory services to the pharmaceutical, biotechnology and diagnostics industries, has co-authored a paper appearing in the March issue of Clinical Chemistry. The article explores the contribution of assay methodologies in the risk score classification of cardiovascular disease.
In the paper, Dr. Leary and her co-authors evaluated the accuracy of cardiovascular disease risk score classification by direct LDL cholesterol, calculated LDL cholesterol, and non-HDL cholesterol compared to classification by reference measurement procedures performed at the Centers for Disease Control and Prevention.
A total of 175 individuals were examined, including 138 with cardiovascular disease or conditions that may affect measurement of LDL cholesterol.
The study concluded that except for individuals with elevated triglycerides, 7 of 8 direct LDL cholesterol methods failed to show improved cardiovascular disease risk score classification over the corresponding calculated LDL cholesterol methods.
Non-HDL cholesterol showed overall the best concordance with the reference measurement procedures for cardiovascular disease risk score classification of both normal and hypertriglyceridemic individuals.
"Most clinical papers pretty much ignore assay differences and their contribution in the interpretation of study findings," said Dr. Leary. "We have presented evidence that not all assays for cardiovascular risk are equally accurate, a conclusion that may help select the appropriate assay for each study and refine methodologies that target those patients at risk for cardiovascular disease."