Clinical Memory Research Unit, Lund University, Malmö, Sweden; Memory Clinic, Skåne University Hospital, Malmö, Sweden.
Institute for Neurodegenerative Disorders, New Haven, CT, USA.
Alzheimers Dement. 2018 Nov;14(11):1470-1481. doi: 10.1016/j.jalz.2018.01.010. Epub 2018 Mar 1.
We studied whether fully automated Elecsys cerebrospinal fluid (CSF) immunoassay results were concordant with positron emission tomography (PET) and predicted clinical progression, even with cutoffs established in an independent cohort.
Cutoffs for Elecsys amyloid-β (Aβ), total tau/Aβ(1-42), and phosphorylated tau/Aβ(1-42) were defined against [F]flutemetamol PET in Swedish BioFINDER (n = 277) and validated against [F]florbetapir PET in Alzheimer's Disease Neuroimaging Initiative (n = 646). Clinical progression in patients with mild cognitive impairment (n = 619) was studied.
CSF total tau/Aβ(1-42) and phosphorylated tau/Aβ(1-42) ratios were highly concordant with PET classification in BioFINDER (overall percent agreement: 90%; area under the curve: 94%). The CSF biomarker statuses established by predefined cutoffs were highly concordant with PET classification in Alzheimer's Disease Neuroimaging Initiative (overall percent agreement: 89%-90%; area under the curves: 96%) and predicted greater 2-year clinical decline in patients with mild cognitive impairment. Strikingly, tau/Aβ ratios were as accurate as semiquantitative PET image assessment in predicting visual read-based outcomes.
Elecsys CSF biomarker assays may provide reliable alternatives to PET in Alzheimer's disease diagnosis.
我们研究了全自动化 Elecsys 脑脊液（CSF）免疫分析结果是否与正电子发射断层扫描（PET）一致，并预测了临床进展，即使使用在独立队列中建立的截止值也是如此。
针对瑞典 BioFINDER（n=277）中的 [F]flutemetamol PET 定义了 Elecsys 淀粉样蛋白-β（Aβ）、总 tau/Aβ（1-42）和磷酸化 tau/Aβ（1-42）的截止值，并在阿尔茨海默病神经影像学倡议（n=646）中针对 [F]florbetapir PET 进行了验证。研究了轻度认知障碍患者（n=619）的临床进展情况。
CSF 总 tau/Aβ（1-42）和磷酸化 tau/Aβ（1-42）比值与 BioFINDER 中的 PET 分类高度一致（总体一致性百分比：90%；曲线下面积：94%）。在阿尔茨海默病神经影像学倡议中，通过预设截止值确定的 CSF 生物标志物状态与 PET 分类高度一致（总体一致性百分比：89%-90%；曲线下面积：96%），并预测轻度认知障碍患者的 2 年临床下降更大。引人注目的是，tau/Aβ 比值在预测基于视觉阅读的结果方面与半定量 PET 图像评估一样准确。
Elecsys CSF 生物标志物检测可能是阿尔茨海默病诊断中替代 PET 的可靠方法。
