NMR measurement of LDL particle number using the Vantera® Clinical Analyzer

https://doi.org/10.1016/j.clinbiochem.2014.07.015Get rights and content
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Highlights

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

  • In some patients, LDL-P is more strongly associated with CV events than LDL-C.

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

  • NMR-based LDL-P is FDA cleared for clinical use as an IVD on the Vantera Analyzer.

Abstract

Background

The Vantera Clinical Analyzer was developed to enable fully-automated, high-throughput nuclear magnetic resonance (NMR) spectroscopy measurements in a clinical laboratory setting. NMR-measured low-density lipoprotein particle number (LDL-P) has been shown to be more strongly associated with cardiovascular disease outcomes than LDL cholesterol (LDL-C) in individuals for whom these alternate measures of LDL are discordant.

Objective

The aim of this study was to assess the analytical performance of the LDL-P assay on the Vantera Clinical Analyzer as per Clinical Laboratory Standards Institute (CLSI) guidelines.

Results

Sensitivity and linearity were established within the range of 300–3500 nmol/L. For serum pools containing low, medium and high levels of LDL-P, the inter-assay, intra-assay precision and repeatability gave coefficients of variation (CVs) between 2.6 and 5.8%. The reference interval was determined to be 457–2282 nmol/L and the assay was compatible with multiple specimen collection tubes. Of 30 substances tested, only 2 exhibited the potential for assay interference. Moreover, the LDL-P results from samples run on two NMR platforms, Vantera Clinical Analyzer and NMR Profiler, showed excellent correlation (R2 = 0.96).

Conclusions

The performance characteristics suggest that the LDL-P assay is suitable for routine testing in the clinical laboratory on the Vantera Clinical Analyzer, the first automated NMR platform that supports NMR-based clinical assays.

Abbreviations

NMR
Nuclear magnetic resonance
LDL-P
Low density lipoprotein particle number
LDL-C
Low density lipoprotein-cholesterol
CLSI
Clinical Laboratory Standards Institute
CV
Coefficient of variation
CVD
Cardiovascular disease
LDL
Low density lipoprotein
HDL
High density lipoprotein
HDL-C
High density lipoprotein-cholesterol
VLDL
Very low density lipoprotein
IDL
Intermediate density lipoprotein
LDT
Laboratory developed test
IVD
In vitro diagnostic
FDA
Food and Drug Administration
HDL-P
High density lipoprotein particle number
CLIA
Clinical Laboratory Improvement Amendments
LOB
Limit of blank
LOD
Limit of detection
LOQ
Limit of quantitation
SD
Standard deviation
DMSO
Dimethyl sulfoxide

Keywords

Lipoprotein particle analysis
Low-density lipoprotein
NMR spectroscopy
Cardiovascular disease
CV risk management

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