Elecsys®β-淀粉样蛋白（1-42）脑脊液测定与比较测定和 LC-MS/MS 的方法比较研究。
Method comparison study of the Elecsys® β-Amyloid (1-42) CSF assay versus comparator assays and LC-MS/MS.
机构信息
Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA 19104, USA.
Clinical Memory Research Unit, Lund University, VO Minnessjukdomar, Simrisbanv 14/4, 212 24 Malmö, Sweden; Memory Clinic, Skåne University Hospital, Inga Marie Nilssons gata 47, 214 21 Malmö, Sweden.
出版信息
Clin Biochem. 2019 Oct;72:7-14. doi: 10.1016/j.clinbiochem.2019.05.006. Epub 2019 May 23.
BACKGROUND
Alzheimer's disease (AD) biomarkers, such as cerebrospinal fluid (CSF) amyloid-β (1-42; Aβ42), can provide high diagnostic accuracy. Several immunoassays are available for Aβ42 quantitation, but standardisation across assays remains an issue. We compared the Elecsys® β-Amyloid (1-42) CSF assay with three assays and two liquid chromatography tandem mass spectrometry (LC-MS/MS) methods.
METHODS
Three method comparison studies evaluated the correlation between the Elecsys® β-Amyloid (1-42) CSF assay versus: INNOTEST® β-AMYLOID(1-42) (860 samples) and the Roche Diagnostics-developed LC-MS/MS method (250 samples); INNO-BIA AlzBio3 and the University of Pennsylvania (UPenn)-developed LC-MS/MS method (250 samples); and ADx-EUROIMMUN Beta-Amyloid (1-42) enzyme-linked immunosorbent assay (ELISA) (49 samples).
RESULTS
High correlation was demonstrated between Elecsys® β-Amyloid (1-42) CSF and comparator assays: INNOTEST® β-AMYLOID(1-42) (Spearman's ρ, 0.954); INNO-BIA AlzBio3 (Spearman's ρ, 0.864); ADx-EUROIMMUN Beta-Amyloid (1-42) ELISA (Pearson's r, 0.925). Elecsys® assay and LC-MS/MS measurements were highly correlated: Pearson's r, 0.949 (Roche Diagnostics-developed method) and 0.943 (UPenn-developed method).
CONCLUSION
Findings from this multicentre evaluation further support use of the Elecsys® β-Amyloid (1-42) CSF assay to aid AD diagnosis. CSF-based certified reference materials should improve agreement across assays and mass spectrometry-based methods, which is essential to establish a global uniform CSF Aβ42 cut-off to detect amyloid pathology.
背景
阿尔茨海默病（AD）生物标志物，如脑脊液（CSF）中的淀粉样蛋白-β（1-42；Aβ42），可提供较高的诊断准确性。目前已有多种免疫分析法可用于定量 Aβ42，但检测方法之间的标准化仍是一个问题。我们比较了 Elecsys®β-淀粉样蛋白（1-42）CSF 检测法与三种检测方法和两种液相色谱串联质谱（LC-MS/MS）方法的相关性。
方法
三项方法比较研究评估了 Elecsys®β-淀粉样蛋白（1-42）CSF 检测法与 INNOTEST®β-淀粉样蛋白（1-42）（860 个样本）和罗氏诊断公司开发的 LC-MS/MS 方法（250 个样本），INNO-BIA AlzBio3 和宾夕法尼亚大学（UPenn）开发的 LC-MS/MS 方法（250 个样本），以及 ADx-EUROIMMUN Beta-淀粉样蛋白（1-42）酶联免疫吸附测定（ELISA）（49 个样本）之间的相关性。
结果
Elecsys®β-淀粉样蛋白（1-42）CSF 与比较检测法高度相关：INNOTEST®β-淀粉样蛋白（1-42）（Spearman's ρ，0.954）；INNO-BIA AlzBio3（Spearman's ρ，0.864）；ADx-EUROIMMUN Beta-淀粉样蛋白（1-42）ELISA（Pearson's r，0.925）。Elecsys®检测法与 LC-MS/MS 测量值高度相关：Pearson's r，罗氏诊断公司开发的方法为 0.949，UPenn 开发的方法为 0.943。
结论
这项多中心评估的结果进一步支持使用 Elecsys®β-淀粉样蛋白（1-42）CSF 检测法辅助 AD 诊断。CSF 认证参考物质应提高检测方法之间以及基于质谱的方法之间的一致性，这对于建立全球统一的 CSF Aβ42 临界值以检测淀粉样蛋白病理学至关重要。
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