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The extended lipid panel assay: a clinically-deployed high-throughput nuclear magnetic resonance method for the simultaneous measurement of lipids and Apolipoprotein B
Lipids in Health and Disease ( IF 4.5 ) Pub Date : 2020-12-01 , DOI: 10.1186/s12944-020-01424-2
Erwin Garcia 1 , Dennis W Bennett 1 , Margery A Connelly 1 , Elias J Jeyarajah 1 , Franklin C Warf 1 , Irina Shalaurova 1 , Steven P Matyus 1 , Justyna Wolak-Dinsmore 1 , David N Oskardmay 1 , Randolph M Young 2 , Maureen Sampson 3 , Alan T Remaley 4 , James D Otvos 1
Affiliation  

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.

中文翻译:

扩展的脂质面板分析:一种临床部署的高通量核磁共振方法,用于同时测量脂质和载脂蛋白 B

采用化学/酶促方法的标准脂质面板检测可测量总胆固醇 (TC)、甘油三酯 (TG) 和高密度脂蛋白胆固醇 (HDL-C),从中计算出低密度脂蛋白胆固醇 (LDL-C) 的估计值。这些脂质测量值普遍用于指导动脉粥样硬化心血管疾病风险的管理。载脂蛋白 B (apoB) 在降脂治疗决策方面通常被认为优于 LDL-C,但由于增加了分析成本,apoB 免疫分析的执行频率相对较低。本研究的目的是开发和验证一种快速、高通量、无试剂检测的性能,产生“扩展脂质面板”(ELP),其中包括 apoB、使用已在临床上部署用于脂蛋白颗粒和其他测试的 Vantera® 核磁共振 (NMR) 分析仪平台。偏最小二乘回归模型使用血浆或血清的质子核磁共振谱的定义区域作为输入,创建以同时量化 TC、TG、HDL-C 和 apoB。采用通过化学方法独立分析脂质和 apoB 的患者血清的大型训练集 (n > ~ 1000),以确保预测模型反映人群广泛的脂质成分多样性。对 NMR ELP 分析的分析性能进行了综合评估。TC、TG、HDL-C 和 apoB 的化学测量值和 ELP 测定值之间表现出极好的一致性,相关系数范围从 0.980 到 0.997。使用低、中、和高水平血清库给出了 4 种分析物的变异系数,低浓度为 1.0 到 3.8%,中等浓度为 1.0 到 1.7%,高浓度为 0.9 到 1.3%。20 天内实验室内精度的相应值分别为 1.4 至 3.6%、1.2 至 2.3% 和 1.0 至 1.9%。5 天内在三个地点进行的独立测试产生了高度一致的测定结果。测试的 38 种内源性或外源性物质均未观察到重大干扰。广泛的检测性能评估证实 NMR ELP 检测有效、稳健,并且基本上等同于用于临床测量脂质和 apoB 的标准化学检测。apoB 的常规报告以及标准的脂质测量可以促进 apoB 在临床决策中的更广泛应用。
更新日期:2020-12-01
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