The extended lipid panel assay: a clinically-deployed high-throughput nuclear magnetic resonance method for the simultaneous measurement of lipids and Apolipoprotein B.
The extended lipid panel assay: a clinically-deployed high-throughput nuclear magnetic resonance method for the simultaneous measurement of lipids and Apolipoprotein B.
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扩展的脂质面板测定法：一种用于同时测量脂质和载脂蛋白的临床部署的高通量核磁共振方法。
DOI：
10.1186/s12944-020-01424-2
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发表时间：
2020-12-01
影响因子：
4.5
通讯作者：
Otvos JD
中科院分区：
文献类型：
--
作者：
Garcia E;Bennett DW;Connelly MA;Jeyarajah EJ;Warf FC;Shalaurova I;Matyus SP;Wolak-Dinsmore J;Oskardmay DN;Young RM;Sampson M;Remaley AT;Otvos JD
采用化学/酶法的标准脂质组测定法测量总胆固醇（TC）、甘油三酯（TG）和高密度脂蛋白胆固醇（HDL-C），从中计算低密度脂蛋白胆固醇（LDL-C）的估计值。这些血脂指标普遍用于指导动脉粥样硬化性心血管疾病风险的管理。载脂蛋白B（apo B）通常被认为在制定降脂治疗决策方面上级LDL-C，但由于增加的分析成本，apo B免疫测定相对较少进行。本研究的目的是开发和验证一种快速、高通量、无试剂检测方法的性能，该方法使用已在临床上部署用于脂蛋白颗粒和其他检测的Vantera®核磁共振（NMR）分析仪平台，产生包括apoB的“扩展脂质组”（ELP）。建立偏最小二乘回归模型，使用血浆或血清质子NMR光谱的定义区域作为输入，以同时定量TC、TG、HDL-C和apoB。采用通过化学方法独立分析脂质和apoB的患者血清的大训练集（n > ~ 1000），以确保预测模型反映群体的广泛脂质组成多样性。全面评价了NMR ELP测定的分析性能。TC、TG、HDL-C和apoB的化学测定值与ELP测定值之间表现出良好的一致性，相关系数范围为0.980至0.997。使用低、中和高水平血清样本池测量的运行内精密度研究得出4种分析物的变异系数范围为：低水平样本池1.0 - 3.8%，中等水平样本池1.0 - 1.7%，高水平样本池0.9 - 1.3%。20天内实验室内精密度的相应值分别为1.4 - 3.6%、1.2 - 2.3%和1.0 - 1.9%。在三个研究中心进行的5天独立检测产生了高度一致的检测结果。38种供试内源性或外源性物质未观察到重大干扰。广泛的测定性能评价证实，NMR ELP测定是有效的、稳健的，并且实质上等同于用于脂质和apoB的临床测量的标准化学测定。常规报告载脂蛋白B和标准血脂指标有助于更广泛地利用载脂蛋白B进行临床决策。在线版本包含补充材料，可通过10.1186/s12944-020-01424-2获得。
Standard lipid panel assays employing chemical/enzymatic methods measure total cholesterol (TC), triglycerides (TG), and high-density lipoprotein cholesterol (HDL-C), from which are calculated estimates of low-density lipoprotein cholesterol (LDL-C). These lipid measures are used universally to guide management of atherosclerotic cardiovascular disease risk. Apolipoprotein B (apoB) is generally acknowledged to be superior to LDL-C for lipid-lowering therapeutic decision-making, but apoB immunoassays are performed relatively infrequently due to the added analytic cost. The aim of this study was to develop and validate the performance of a rapid, high-throughput, reagent-less assay producing an “Extended Lipid Panel” (ELP) that includes apoB, using the Vantera® nuclear magnetic resonance (NMR) analyzer platform already deployed clinically for lipoprotein particle and other testing. Partial least squares regression models, using as input a defined region of proton NMR spectra of plasma or serum, were created to simultaneously quantify TC, TG, HDL-C, and apoB. Large training sets (n > ~ 1000) of patient sera analyzed independently for lipids and apoB by chemical methods were employed to ensure prediction models reflect the wide lipid compositional diversity of the population. The analytical performance of the NMR ELP assay was comprehensively evaluated. Excellent agreement was demonstrated between chemically-measured and ELP assay values of TC, TG, HDL-C and apoB with correlation coefficients ranging from 0.980 to 0.997. Within-run precision studies measured using low, medium, and high level serum pools gave coefficients of variation for the 4 analytes ranging from 1.0 to 3.8% for the low, 1.0 to 1.7% for the medium, and 0.9 to 1.3% for the high pools. Corresponding values for within-lab precision over 20 days were 1.4 to 3.6%, 1.2 to 2.3%, and 1.0 to 1.9%, respectively. Independent testing at three sites over 5 days produced highly consistent assay results. No major interference was observed from 38 endogenous or exogenous substances tested. Extensive assay performance evaluations validate that the NMR ELP assay is efficient, robust, and substantially equivalent to standard chemistry assays for the clinical measurement of lipids and apoB. Routine reporting of apoB alongside standard lipid measures could facilitate more widespread utilization of apoB for clinical decision-making. The online version contains supplementary material available at 10.1186/s12944-020-01424-2.
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影响因子：
9.3
作者：
Otvos, James D.;Shalaurova, Irina;Tracy, Russell P.
通讯作者：
Tracy, Russell P.
影响因子：
3.3
作者：
Arlot, Sylvain;Celisse, Alain
通讯作者：
Celisse, Alain
影响因子：
4.2
作者：
Jellinger, Paul S.;Handelsman, Yehuda;Davidson, Michael
通讯作者：
Davidson, Michael
影响因子：
2.8
作者：
Matyus, Steven P.;Braun, Paul J.;Connelly, Margery A.
通讯作者：
Connelly, Margery A.
影响因子：
7.4
作者：
Jimenez, Beatriz;Holmes, Elaine;Nicholson, Jeremy K.
通讯作者：
Nicholson, Jeremy K.