阿尔兹海默症标志物测量技术及标准化研究进展

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

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。

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.