HDL particle number measured on the Vantera®, the first clinical NMR analyzer
HDL particle number measured on the Vantera®, the first clinical NMR analyzer
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DOI：
10.1016/j.clinbiochem.2014.11.017
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发表时间：
2015-02-01
影响因子：
2.8
通讯作者：
Connelly, Margery A.
中科院分区：
文献类型：
--
作者：
Matyus, Steven P.;Braun, Paul J.;Connelly, Margery A.
目的：多年来，核磁共振波谱已成功地应用于高密度脂蛋白颗粒的测量，提供了高密度脂蛋白颗粒总数、亚类(小、中、大)和加权平均大小的颗粒浓度。关键的临床研究表明，核磁共振测量的高密度脂蛋白-P与冠状动脉疾病的测量更密切相关，并且比高密度脂蛋白-胆固醇(高密度脂蛋白-C)更能预测心血管疾病(CVD)事件。最近，开发了一种基于核磁共振的临床分析仪Vantera(R)，使脂蛋白测量可以在常规的临床实验室环境中进行。这项研究的目的是评估和报告在Vantera(R)临床分析仪上量化的高密度脂蛋白的性能特征。设计和方法：根据临床和实验室标准协会(CLSI)的指南评估分析性能。为了确保在Vantera(R)临床分析仪上测定的高密度脂蛋白与核磁共振分析仪上高密度脂蛋白的定量结果相似，进行了方法比较。结果：批内和实验室内不确定度在2.0%~3.9%之间。线性范围为10.0~65.0mU/L，参比区间男性(22.0~46.0mU/L)和女性(26.7~52.9mU/L)不同。两个核磁共振平台Vantera(R)临床分析仪和核磁共振Profiler之间的高密度脂蛋白-P浓度具有良好的相关性(R2=0.98)。结论：Vantera(R)临床分析仪的性能特点以及用于标本分析的一次试管取样程序表明，高密度脂蛋白-P法适合于常规临床应用。(C)2014年提交人。加拿大临床化学家协会。由爱思唯尔公司出版。
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 (R), 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 (R) 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 (R) 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 with-in the range of 10.0 to 65.0 mu mol/L. The reference intervals were different between men (22.0 to 46.0 mu mol/L) and women (26.7 to 52.9 mu mol/L). HDL-P concentrations between two NMR platforms, Vantera (R) 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 (R) Clinical Analyzer, suggest that the HDL-P assay is suitable for routine clinical applications. (C) 2014 The Authors. The Canadian Society of Clinical Chemists. Published by Elsevier Inc.