NMR measurement of LDL particle number using the Vantera (R) Clinical Analyzer

作者：Matyus Steven P^*; Braun Paul J; Wolak Dinsmore Justyna; Jeyarajah Elias J; Shalaurova Irina; Xu Yuan; Warner Suzette M; Clement Thomas S; Connelly Margery A; Fischer Timothy J

来源：Clinical Biochemistry, 2014, 47(16-17): 203-210.

DOI：10.1016/j.clinbiochem.2014.07.015

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

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 (CBI) 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.

• 出版日期2014-11