阿尔兹海默症标志物测量技术及标准化研究进展

周希蕊; 顾仁济; 马瑞敏; 姜文灿; 罗施中; 冯流星

doi:10.12338/j.issn.2096-9015.2024.0054

阿尔兹海默症标志物测量技术及标准化研究进展

doi: 10.12338/j.issn.2096-9015.2024.0054

1.
中国计量科学研究院，北京 100029
2.
北京化工大学，北京 100029
3.
首都医科大学附属北京天坛医院，北京 100070

基金项目: 国家重点研发计划项目（2021YFC2103900）；国家市场监管重点实验室（营养与健康化学计量及应用）开放课题（AKYKF2312）。

详细信息

作者简介:
周希蕊（1987-），中国计量科学研究院副研究员，研究方向：蛋白质计量技术研究，邮箱：zhouxr@nim.ac.cn

通讯作者:
冯流星（1977-），中国计量科学研究院研究员，研究方向：金属组学计量技术研究，邮箱：fenglx@nim.ac.cn

中图分类号: TB99
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- 被引次数: 0
出版历程
- 收稿日期: 2024-02-27
- 录用日期: 2024-03-27
- 修回日期: 2024-03-28
- 网络出版日期: 2024-07-04

Advances in Measurement Techniques and Standardization of Alzheimer's Disease Biomarkers

1.
National Institute of Metrology, Beijing 100029, China
2.
Beijing University of Chemical Technology, Beijing 100029, China
3.
Laboratory of Beijing Tiantan Hospital and Capital Medical University, Beijing 100070, China

摘要

摘要: 阿尔兹海默症是一种不可逆的神经退行疾病，在65岁以上老年人群中高发；随着各国老龄化程度的加深，AD已经成为影响全球公共健康和社会发展的重大问题。AD的发病机制至今不明确，目前尚无有效的药物可以逆转或阻止病情发展。利用全面的、高度特异性的诊断标志物组合对AD进行早期识别是疾病精准诊断的关键，也是实现疾病有效治疗的先决条件。针对AD诊断标志物开发高灵敏、高准确且高通量的定量技术，是获取可靠结果的有效途径，也是AD临床诊断的迫切需求。推进AD诊断标志物相关检验的标准化，能够显著提升不同检测平台所获结果的一致性、互换性和溯源性。综述梳理了AD诊断标准的演变和药物研发现状，列举了疾病相关的重要诊断标志物，介绍并对比了相关测量检测技术，最后对AD诊断标志物精准测量技术的标准化现状进行了分析并做出展望，希望为推动相关领域标准物质的开发和参考测量程序的建立，以及IVD产品和平台的性能提升提供有益的指导。
- 计量学 /
- 阿尔兹海默症 /
- 诊断标志物 /
- 定量技术 /
- 标准化 /
- 标准物质 /
- 参考测量程序
Abstract: Alzheimer's disease (AD) is an irreversible neurodegenerative disorder highly prevalent in the elderly population aged 65 and above. With increasing global population aging, AD has become a major issue affecting public health and social development worldwide. The pathogenesis of AD remains unclear, and currently, there are no effective drugs to reverse or prevent disease progression. Utilizing a comprehensive and highly specific combination of diagnostic biomarkers for early AD detection is crucial for precise diagnosis and a prerequisite for effective treatment. Developing highly sensitive, accurate, and high-throughput quantitative techniques for AD diagnostic biomarkers is an effective approach to obtain reliable results and meets the urgent need for clinical AD diagnosis. Promoting the standardization of AD diagnostic biomarker-related tests can significantly improve the consistency, interchangeability, and traceability of results obtained from different detection platforms. This review outlines the evolution of AD diagnostic criteria and the current status of drug development, lists important disease-related diagnostic biomarkers, introduces and compares relevant measurement and detection techniques, and finally analyzes and prospects the standardization status of precise measurement techniques for AD diagnostic biomarkers. We aim to provide valuable guidance for promoting the development of related reference materials and the establishment of reference measurement procedures, as well as improving the performance of in vitro diagnostic (IVD) products and platforms in this field.
- metrology /
- Alzheimer's disease /
- biomarkers /
- quantitation techniques /
- standardization /
- certified reference material /
- reference measurement procedure

HTML全文

图 1 APP蛋白的切割方式

Figure 1. Cleavage of amyloid precursor protein (APP)

下载: 全尺寸图片幻灯片

图 2 AD症中Tau蛋白的致病机制

Figure 2. Pathogenesis of Tau protein in Alzheimer's disease

下载: 全尺寸图片幻灯片

图 3 LC-MS/MS检测体液样本中Aβ_1-40和Aβ_1-42的工作流程

Figure 3. Workflow for the detection of Aβ_1-42 and Aβ_1-40 in biofluids

下载: 全尺寸图片幻灯片

表 1 不同机构建立的脑脊液中Aβ的质谱测量程序的测试性能分析

Table 1. Quantification performance of reference measurement procedures established by different organizations

发布机构	美国辉瑞公司	瑞典萨尔格林斯卡医院	宾夕法尼亚大学佩雷尔曼医学院	北京协和医院
检测方法	UPLC/MS/MS^[74]	LC/MS/MS^[75]	UPLC/MS/MS^[76]	UPLC/MS/MS^[77]
前处理	固相萃取	固相萃取	固相萃取	顺序提取磁珠富集
脑脊液体积	0.2 mL	0.18 mL	0.1 mL	0.2 mL
色谱仪器	Acquity UPLC	Acella 1250	Acquity UPLC	Acquity UPLC
色谱仪器	(Waters)	Acella 1250	(Waters)	(Waters)
质谱仪器	三重四极杆	Q-Exactive quadrupole-Orbitrap	三重四极杆	三重四极杆
质谱仪器	Xevo TQ-S (Waters)	(Thermo Scientific)	Xevo TQ-S (Waters)	Xevo TQ-XS(Waters)
色谱柱	BEH 300	Pro-Swift RP-4H	BEH 300	BEH C4 柱
	2.1 mm × 150 mm	1 mm × 250 mm	2.1 mm × 300 mm	2.1 mm × 50 mm
	(Waters)	(Thermo Scientific)	(Waters)	(Waters)
标曲范围
Aβ_1-40	100～10000 pg/mL	150～4000 pg/mL	100～3000 pg/mL	500～25000 pg/mL
Aβ_1-42	100～10000 pg/mL	1500～40000 pg/mL	200～20000 pg/mL	100～5000 pg/mL
离子对
Aβ_1-40	1083.0>1053.6	1083.47>17种子离子	1083.6>1054	1083.2>1053.77
Aβ_1-42	1129.0>1078.5	1129.58>15种子离子	1129.6>1079	1129.27>1106.8

下载: 导出CSV

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