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HDL particle number measured on the Vantera®, the first clinical NMR analyzer

Authors :
Amy K. Saenger
Suzette M. Warner
Margery A. Connelly
Timothy J. Fischer
Irina Shalaurova
Elias J. Jeyarajah
Paul J. Braun
Steven P. Matyus
Justyna Wolak-Dinsmore
Source :
Clinical Biochemistry. 48:148-155
Publication Year :
2015
Publisher :
Elsevier BV, 2015.

Abstract

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.

Details

ISSN :
00099120
Volume :
48
Database :
OpenAIRE
Journal :
Clinical Biochemistry
Accession number :
edsair.doi.dedup.....2844604842643c49ea96b3ad42acfb78
Full Text :
https://doi.org/10.1016/j.clinbiochem.2014.11.017