title: HDL particle number measured on the Vantera®, the first clinical NMR analyzer.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: LipoScience, Inc., Raleigh, NC, USA. Electronic address: steven.matyus@liposcience.com.
authors.forename: Steven P
authors.initials: SP
authors.lastname: Matyus
authors.affiliation: LipoScience, Inc., Raleigh, NC, USA.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Braun
authors.affiliation: LipoScience, Inc., Raleigh, NC, USA.
authors.forename: Justyna
authors.initials: J
authors.lastname: Wolak-Dinsmore
authors.affiliation: Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.
authors.forename: Amy K
authors.initials: AK
authors.lastname: Saenger
authors.affiliation: LipoScience, Inc., Raleigh, NC, USA.
authors.forename: Elias J
authors.initials: EJ
authors.lastname: Jeyarajah
authors.affiliation: LipoScience, Inc., Raleigh, NC, USA.
authors.forename: Irina
authors.initials: I
authors.lastname: Shalaurova
authors.affiliation: LipoScience, Inc., Raleigh, NC, USA.
authors.forename: Suzette M
authors.initials: SM
authors.lastname: Warner
authors.affiliation: LipoScience, Inc., Raleigh, NC, USA.
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Fischer
authors.affiliation: LipoScience, Inc., Raleigh, NC, USA.
authors.forename: Margery A
authors.initials: MA
authors.lastname: Connelly
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D008076:Cholesterol, HDL / Q000097:blood*; D005260:Female; D006801:Humans; D009682:Magnetic Resonance Spectroscopy / Q000295:instrumentation* / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010316:Particle Size; D012015:Reference Standards; D015203:Reproducibility of Results; D013048:Specimen Handling / Q000295:instrumentation; D055815:Young Adult
chemical_list: D008076:Cholesterol, HDL
keywords: Cardiovascular disease; High-density lipoprotein; Lipoprotein particle analysis; NMR spectroscopy