Key result
HDL-P concentrations measured on the Vantera Clinical Analyzer demonstrated excellent correlation with the NMR Profiler (R2 = 0.98), with within-lab imprecision ranging from 2.0% to 3.9%.
Why the study?
Does the Vantera Clinical Analyzer provide comparable HDL-P quantification to the established NMR Profiler for routine clinical applications?
Does the Vantera Clinical Analyzer provide comparable HDL-P quantification to the established NMR Profiler for routine clinical applications?
Effect estimate: R2 = 0.98
The Vantera Clinical Analyzer provides reliable and accurate quantification of HDL particle number, comparable to established NMR profiling, supporting its use in routine clinical laboratories.
NMR HDL-P may refine CVD risk prediction; leaves open clinical adoption pending validation in prospective cohorts.
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 65.0 μmol/L. The reference intervals were different between men (22.0 to 46.0 μmol/L) and women (26.7 to 52.9 μmol/L). HDL-P concentrations between two NMR platforms, Vantera(®) Clinical Analyzer and NMR Profiler, demonstrated excellent correlation (R(2) = 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.
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Matyus et al. (2014) studied this question. HDL-P quantification on the Vantera Clinical Analyzer vs. NMR Profiler was evaluated on Method comparison between Vantera Clinical Analyzer and NMR Profiler (R2 = 0.98). HDL-P concentrations measured on the Vantera Clinical Analyzer demonstrated excellent correlation with the NMR Profiler (R2 = 0.98), with within-lab imprecision ranging from 2.0% to 3.9%.