Elsevier

Clinical Biochemistry

Volume 48, Issue 3, February 2015, Pages 148-155
Clinical Biochemistry

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

https://doi.org/10.1016/j.clinbiochem.2014.11.017Get rights and content
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Highlights

  • The Vantera Clinical Analyzer is the first NMR analyzer designed for clinical use.

  • In recent studies, HDL-P was more strongly associated with CV events than HDL-C.

  • The Vantera HDL-P assay performance is robust and suitable for clinical testing.

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 (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.

Abbreviations

NMR
nuclear magnetic resonance
HDL
high-density lipoprotein
HDL-P
HDL particle number
HDL
high-density lipoprotein
CVD
cardiovascular disease
HDL-C
high-density lipoprotein—cholesterol
LDL-C
low-density lipoprotein—cholesterol
VLDL
very low density lipoprotein
IDL
intermediate density lipoprotein
LDL
low-density lipoprotein
LDL-P
LDL particle number
FDA
Food and Drug Administration
CLIA
Clinical Laboratory Improvement Amendments
LOB
limit of blank
LOD
limit of detection
LOQ
limit of quantitation
CLSI
Clinical Laboratory Standards Institute
CV
coefficient of variation
CI
confidence intervals
IM
ion mobility
CIM
calibrated ion mobility

Keywords

Lipoprotein particle analysis
High-density lipoprotein
NMR spectroscopy
Cardiovascular disease

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