ORIGINAL RESEARCH article

Front. Aging Neurosci.

Sec. Alzheimer's Disease and Related Dementias

Volume 17 - 2025 | doi: 10.3389/fnagi.2025.1599761

This article is part of the Research TopicBlood, Cerebrospinal Fluid, and Vascular Biomarkers for DementiaView all 17 articles

A High-Accuracy, Low-Cost Blood Test for Alzheimer's Disease: Validating P-tau181/Aβ42 in Real-World Cohorts

Provisionally accepted
Dequan  LiuDequan Liu1,2Hang  LiHang Li1,2Qing  LiuQing Liu3Haiyan  LiHaiyan Li1,2Yuanyuan  TangYuanyuan Tang3Kaiting  ChengKaiting Cheng3Tong  LiTong Li1,2Yulan  ChuYulan Chu1,2Xiaodong  JiaXiaodong Jia1,2Wenying  YuWenying Yu1,2Hailan  ZhouHailan Zhou1,2Keqiang  YanKeqiang Yan1,2*
  • 1Tianjin Key Laboratory of Multi-omics Precision Diagnosis Technology for Neurological Diseases, Tianjin, China
  • 2Tianjin Kingmed Diagnostics Laboratory Co.Ltd, Tianjin, China
  • 3GuangZhou Kingmed Diagnostics Laboratory Co.Ltd, Guangzhou, China

The final, formatted version of the article will be published soon.

Objective: To evaluate the diagnostic performance of plasma P-tau181/Aβ42 measured via flow cytometry as a cost-effective tool for Alzheimer's disease (AD) diagnosis.Methods: A cohort study involved 123 healthy controls, 60 AD/mild cognitive impairment (MCI) patients, 34 subcortical ischemic vascular disease (SIVD) patients, and 34 frontotemporaldementia (FTD) patients. Plasma P-tau181 and Aβ42 levels were measured using flow cytometry and cross-validated with Single-molecule Array (SIMOA). Publicly available Chinese cohort data were reanalyzed for comparative performance.Results: The P-tau181/Aβ42 ratio revealed significant differences between groups. A reference interval (0–0.109) achieved 96.2% diagnostic accuracy (95.0% sensitivity, 96.7% specificity) for AD versus controls, distinguishing AD from SIVD (88.3% accuracy) and FTD (86.2% accuracy). Flow cytometry-based P-tau181/Aβ42 showed 88.3% consistency with SIMOA-based P-tau217, while SIMOA-based P-tau181/Aβ42 achieved 92.3% accuracy.Conclusions: Flow cytometry-based P-tau181/Aβ42 offers a cost-effective and accurate diagnostic method for AD, with performance comparable to SIMOA.Significance: This biomarker supports scalable AD screening in secondary healthcare settings, overcoming accessibility and cost barriers in resource-limited environments.

Keywords: Alzheimer's disease, Plasma biomarkers, P-tau181/Aβ42, SiMoA, Flow Cytometry

Received: 25 Mar 2025; Accepted: 22 May 2025.

Copyright: © 2025 Liu, Li, Liu, Li, Tang, Cheng, Li, Chu, Jia, Yu, Zhou and Yan. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Keqiang Yan, Tianjin Kingmed Diagnostics Laboratory Co.Ltd, Tianjin, China

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