一种新型全自动电化学发光免疫分析法检测人脑脊液中β-淀粉样蛋白（1-42）的技术性能。
Technical performance of a novel, fully automated electrochemiluminescence immunoassay for the quantitation of β-amyloid (1-42) in human cerebrospinal fluid.
机构信息
Roche Diagnostics GmbH, Penzberg, Germany.
Clinical Neurochemistry Laboratory, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at University of Gothenburg, Mölndal, Sweden; UCL Institute of Neurology, London, UK.
出版信息
Alzheimers Dement. 2016 May;12(5):517-26. doi: 10.1016/j.jalz.2015.09.009. Epub 2015 Nov 10.
INTRODUCTION
Available assays for quantitation of the Alzheimer's disease (AD) biomarker amyloid-beta 1-42 (Aβ [1-42]) in cerebrospinal fluid demonstrate significant variability and lack of standardization to reference measurement procedures (RMPs). We report analytical performance data for the novel Elecsys β-amyloid (1-42) assay (Roche Diagnostics).
METHODS
Lot-to-lot comparability was tested using method comparison. Performance parameters were measured according to Clinical & Laboratory Standards Institute (CLSI) guidelines. The assay was standardized to a Joint Committee for Traceability in Laboratory Medicine (JCTLM) approved RMP.
RESULTS
Limit of quantitation was <11.28 pg/mL, and the assay was linear throughout the measuring range (200-1700 pg/mL). Excellent lot-to-lot comparability was observed (correlation coefficients [Pearson's r] >0.995; bias in medical decision area <2%). Repeatability coefficients of variation (CVs) were 1.0%-1.6%, intermediate CVs were 1.9%-4.0%, and intermodule CVs were 1.1%-3.9%. Estimated total reproducibility was 2.0%-5.1%. Correlation with the RMP was good (Pearson's r, 0.93).
DISCUSSION
The Elecsys β-amyloid (1-42) assay has high analytical performance that may improve biomarker-based AD diagnosis.
简介
现有的阿尔茨海默病（AD）生物标志物淀粉样蛋白-β 1-42（Aβ[1-42]）在脑脊液中的定量检测方法存在明显的变异性，且缺乏与参考测量程序（RMP）的标准化。我们报告了新型 Elecsys β-淀粉样蛋白（1-42）检测（罗氏诊断）的分析性能数据。
方法
采用方法比较测试了批间可比性。根据临床和实验室标准协会（CLSI）指南测量性能参数。该检测已标准化为联合临床化学溯源性委员会（JCTLM）批准的 RMP。
结果
定量限<11.28pg/mL，检测在整个测量范围内（200-1700pg/mL）均呈线性。观察到极好的批间可比性（Pearson 相关系数[r]＞0.995；医学决策区域的偏差＜2%）。重复性变异系数（CVs）为 1.0%-1.6%，中间 CVs 为 1.9%-4.0%，模块间 CVs 为 1.1%-3.9%。估计总再现性 CVs 为 2.0%-5.1%。与 RMP 的相关性良好（Pearson r，0.93）。
讨论
Elecsys β-淀粉样蛋白（1-42）检测具有较高的分析性能，可能有助于改善基于生物标志物的 AD 诊断。
Zotero 插件