title: NMR measurement of LDL particle number using the Vantera Clinical 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 (R(2)=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.
authors: LipoScience Inc., Raleigh, NC, USA. Electronic address: steven.matyus@liposcience.com.
authors: Steven P
authors: SP
authors: Matyus
authors: LipoScience Inc., Raleigh, NC, USA.
authors: Paul J
authors: PJ
authors: Braun
authors: LipoScience Inc., Raleigh, NC, USA.
authors: Justyna
authors: J
authors: Wolak-Dinsmore
authors: LipoScience Inc., Raleigh, NC, USA.
authors: Elias J
authors: EJ
authors: Jeyarajah
authors: LipoScience Inc., Raleigh, NC, USA.
authors: Irina
authors: I
authors: Shalaurova
authors: LipoScience Inc., Raleigh, NC, USA.
authors: Yuan
authors: Y
authors: Xu
authors: LipoScience Inc., Raleigh, NC, USA.
authors: Suzette M
authors: SM
authors: Warner
authors: LipoScience Inc., Raleigh, NC, USA.
authors: Thomas S
authors: TS
authors: Clement
authors: LipoScience Inc., Raleigh, NC, USA.
authors: Margery A
authors: MA
authors: Connelly
authors: LipoScience Inc., Raleigh, NC, USA.
authors: Timothy J
authors: TJ
authors: Fischer
mesh_terms: D008078:Cholesterol, LDL / Q000097:blood*; D006801:Humans; D009682:Magnetic Resonance Spectroscopy / Q000379:methods*; D015203:Reproducibility of Results
chemical_list: D008078:Cholesterol, LDL
keywords: CV risk management; Cardiovascular disease; Lipoprotein particle analysis; Low-density lipoprotein; NMR spectroscopy