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一种用于阿尔茨海默病的高精度、低成本血液检测:在真实世界队列中验证P-tau181/Aβ42

A high-accuracy, low-cost blood test for Alzheimer's disease: validating P-tau181/Aβ42 in real-world cohorts.

作者信息

Liu Dequan, Li Hang, Liu Qing, Li Haiyan, Tang Yuanyuan, Cheng Kaiting, Li Tong, Chu Yulan, Jia Xiaodong, Yu Wenying, Zhou Hailan, Yan Keqiang

机构信息

Tianjin Kingmed Diagnostics Laboratory Co. Ltd., Tianjin, China.

Tianjin Key Laboratory of Multi-omics Precision Diagnosis Technology for Neurological Diseases, Tianjin, China.

出版信息

Front Aging Neurosci. 2025 Jun 16;17:1599761. doi: 10.3389/fnagi.2025.1599761. eCollection 2025.

DOI:10.3389/fnagi.2025.1599761
PMID:40589622
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12206629/
Abstract

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 frontotemporal dementia (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.

CONCLUSION

Flow cytometry-based P-tau181/Aβ42 offers a cost-effective and accurate diagnostic method for AD, with performance comparable to SIMOA. This biomarker supports scalable AD screening in secondary healthcare settings, overcoming accessibility and cost barriers in resource-limited environments. This biomarker supports scalable AD screening in secondary healthcare settings, overcoming accessibility and cost barriers in resource-limited environments.

摘要

目的

评估通过流式细胞术测量血浆P-tau181/Aβ42作为阿尔茨海默病(AD)诊断的一种经济高效工具的诊断性能。

方法

一项队列研究纳入了123名健康对照者、60名AD/轻度认知障碍(MCI)患者、34名皮质下缺血性血管疾病(SIVD)患者和34名额颞叶痴呆(FTD)患者。使用流式细胞术测量血浆P-tau181和Aβ42水平,并与单分子阵列(SIMOA)进行交叉验证。对公开可用的中国队列数据进行重新分析以比较性能。

结果

P-tau181/Aβ42比值在各组之间显示出显著差异。一个参考区间(0-0.109)对AD与对照者的诊断准确率达到96.2%(敏感性95.0%,特异性96.7%),能将AD与SIVD(准确率88.3%)和FTD(准确率86.2%)区分开来。基于流式细胞术的P-tau181/Aβ42与基于SIMOA的P-tau217一致性为88.3%,而基于SIMOA的P-tau181/Aβ42准确率达到92.3%。

结论

基于流式细胞术的P-tau181/Aβ42为AD提供了一种经济高效且准确的诊断方法,其性能与SIMOA相当。这种生物标志物支持在二级医疗保健环境中进行可扩展的AD筛查,克服了资源有限环境中的可及性和成本障碍。这种生物标志物支持在二级医疗保健环境中进行可扩展的AD筛查,克服了资源有限环境中的可及性和成本障碍。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e0/12206629/bc5c4a9ed3be/fnagi-17-1599761-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e0/12206629/8b1846dbf0b2/fnagi-17-1599761-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e0/12206629/6a052bea78de/fnagi-17-1599761-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e0/12206629/7ea7ae9d2297/fnagi-17-1599761-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e0/12206629/06f66da2c6f1/fnagi-17-1599761-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e0/12206629/bc5c4a9ed3be/fnagi-17-1599761-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e0/12206629/8b1846dbf0b2/fnagi-17-1599761-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e0/12206629/6a052bea78de/fnagi-17-1599761-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e0/12206629/7ea7ae9d2297/fnagi-17-1599761-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e0/12206629/06f66da2c6f1/fnagi-17-1599761-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e5e0/12206629/bc5c4a9ed3be/fnagi-17-1599761-g005.jpg

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