Objectives: Nuclear magnetic resonance (NMR) spectroscopy has been successfully applied to the measurement of high-density lipoprotein (HDL) particles, providing particle concentrations for total HDL particle number (HDL-P), HDL subclasses (small, medium, large) and weighted, average HDL size for many years. Key clinical studies have demonstrated that NMR-measured HDL-P was more strongly associated with measures of coronary artery disease and a better predictor of incident cardiovascular disease (CVD) events than HDL-cholesterol (HDL-C). Recently, an NMR-based clinical analyzer, the Vantera®, was developed to allow lipoprotein measurements to be performed in the routine, clinical laboratory setting. The aim of this study was to evaluate and report the performance characteristics for HDL-P quantified on the Vantera® Clinical Analyzer. Design and methods: Assay performance was evaluated according to Clinical and Laboratory Standards Institute (CLSI) guidelines. In order to ensure that quantification of HDL-P on the Vantera® Clinical Analyzer was similar to the well-characterized HDL-P assay on the NMR profiler, a method comparison was performed. Results: The within-run and within-lab imprecision ranged from 2.0% to 3.9%. Linearity was established within the range of 10.0 to 65.0μmol/L. The reference intervals were different between men (22.0 to 46.0μmol/L) and women (26.7 to 52.9μmol/L). HDL-P concentrations between two NMR platforms, Vantera® Clinical Analyzer and NMR Profiler, demonstrated excellent correlation (R2=0.98). Conclusions: The performance characteristics, as well as the primary tube sampling procedure for specimen analysis on the Vantera® Clinical Analyzer, suggest that the HDL-P assay is suitable for routine clinical applications.
- Cardiovascular disease
- High-density lipoprotein
- Lipoprotein particle analysis
- NMR spectroscopy