Diagnostic Accuracy of Plasma p-tau217 for Detecting Pathological Cerebrospinal Fluid Changes in Cognitively Unimpaired Subjects Using the Lumipulse Platform

Francisco Martínez-Dubarbie, A. Guerra-Ruiz, S. López-García, C. Lage, M. Fernández-Matarrubia, J. Infante, A. Pozueta-Cantudo, M. García-Martínez, A. Corrales-Pardo, M. Bravo, M. López-Hoyos, J. Irure-Ventura, E. Valeriano-Lorenzo, M. T. García-Unzueta, P. Sánchez-Juan, E. Rodríguez-Rodríguez
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Abstract

Background

Plasma biomarkers of Alzheimer’s disease (AD), especially p-tau217, are promising tools to identify subjects with amyloid deposition in the brain, determined either by cerebrospinal fluid (CSF) or positron emission tomography. However, it is essential to measure them in an accurate and fully automated way in order to apply them in clinical practice.

Objectives

To evaluate the diagnostic performance of the fully-automated Lumipulse plasma p-tau217 assay in preclinical AD.

Design

Cross-sectional analyses from a prospective cohort.

Setting

A population-based study.

Participants

Volunteers over 55 years without cognitive impairment or contraindications for complementary tests.

Measurements

Plasma p-tau217 was measured with the fully-automated Lumipulse assay, as well as CSF Aβ40, Aβ42, p-taul81, and t-tau levels. We correlated plasma p-tau217 with CSF Aβ40, Aβ42 and p-tau181, and assessed the differences in plasma p-tau217 according to CSF amyloid status (A−/+), AD status (AD+ being those subjects A+T+ and AD- the rest) and ATN group. We performed ROC curves and measured the areas under the curve (AUC) using CSF amyloid as result, and both p-tau217 and ApoE4 status as predictor.

Results

We screened 209 cognitively unimpaired volunteers with a mean age 64 years (60–69) and 30.2% of ApoE4 carriers. Plasma p-tau217 correlated significantly with CSF Aβ42/Aβ40 (Rho=−0.51; p-value<0.001) and p-tau181 (r=0.59; p-value<0.001). Its levels were significantly higher in A+ subjects (0.26 pg/ml) compared with A- (0.12 pg/ml; p-value<0.001); and along ATN groups. It predicts CSF amyloid pathology with an AUC of 0.85.

Conclusions

Plasma p-tau217 measured using the Lumipulse platform shows promise as an accurate biomarker of preclinical AD pathology.

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利用 Lumipulse 平台检测血浆 p-tau217 对认知功能未受损受试者脑脊液病理变化的诊断准确性
背景阿尔茨海默病(AD)的血浆生物标记物,尤其是p-tau217,是通过脑脊液(CSF)或正电子发射断层扫描确定脑内淀粉样蛋白沉积受试者的有前途的工具。目的 评估全自动 Lumipulse 血浆 p-tau217 检测法在临床前 AD 中的诊断性能。参与者55岁以上、无认知障碍或辅助检查禁忌症的志愿者。测量采用全自动鲁米帕斯检测法测量血浆p-tau217以及脑脊液Aβ40、Aβ42、p-taul81和t-tau水平。我们将血浆p-tau217与CSF Aβ40、Aβ42和p-tau181相关联,并根据CSF淀粉样状态(A-/+)、AD状态(AD+为A+T+受试者,其余为AD-受试者)和ATN组评估血浆p-tau217的差异。我们以 CSF 淀粉样蛋白为结果,以 p-tau217 和载脂蛋白 E4 状态为预测因子,绘制了 ROC 曲线并测量了曲线下面积(AUC)。血浆 p-tau217 与脑脊液 Aβ42/Aβ40 (Rho=-0.51; p-value<0.001) 和 p-tau181 (r=0.59; p-value<0.001) 显著相关。与 A- 组(0.12 pg/ml;p 值<0.001)相比,A+ 组(0.26 pg/ml)和 ATN 组(0.12 pg/ml;p 值<0.001)的淀粉样蛋白水平明显更高。结论使用 Lumipulse 平台测量的血浆 p-tau217 有希望成为临床前 AD 病理学的准确生物标记物。
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The Journal of Prevention of Alzheimer's Disease
The Journal of Prevention of Alzheimer's Disease Medicine-Psychiatry and Mental Health
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9.20
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期刊介绍: The JPAD Journal of Prevention of Alzheimer’Disease will publish reviews, original research articles and short reports to improve our knowledge in the field of Alzheimer prevention including: neurosciences, biomarkers, imaging, epidemiology, public health, physical cognitive exercise, nutrition, risk and protective factors, drug development, trials design, and heath economic outcomes.JPAD will publish also the meeting abstracts from Clinical Trial on Alzheimer Disease (CTAD) and will be distributed both in paper and online version worldwide.We hope that JPAD with your contribution will play a role in the development of Alzheimer prevention.
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