A novel microfluidics-based method to establish HDL 2b clinical utility showing satisfactory assay performance
Certain HDL subfractions, especially HDL 2b, have been linked to cardiovascular risk and qualitative and/or quantitative changes of these are increasingly considered as emerging cardiovascular risk factors. In this study, a novel microfluidics-based method was employed so as to establish HDL 2b clinical utility. To this end, samples from 503 participants of the Prospective Cardiovascular Muenster (PROCAM) study were analyzed by electrophoresis on a microfluidics system. Among the 503 study participants, 251 were male survivors of myocardial infarction and 252 were matched healthy controls. The novel method showed satisfactory assay performance with an inter-site coefficient of variance of <10% for HDL 2b percentage. Between patients and controls, there were significant differences in the HDL 2b subfraction that were independent of other risk factors. When including HDL 2b percentage in logistic regression analysis, the number of false positives decreased from 64 to 39 and the number of false negatives from 48 to 45 within the study. This novel method shows satisfactory assay performance in addition to drastically reduced analysis times and improved ease of use when compared to other methods, while confirming the clinical relevance of HDL 2b determination suggested by previous studies.


















