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细胞外囊泡（EV）作为疾病的新型生物标志物，在临床检验或疾病诊断和治疗中展现出广阔的应用前景。目前在EV分离技术、EV标志物筛选和验证、EV检测技术等领域均已取得重要进展，而EV真正走进临床实验室，还需要在多组学整合与大数据分析、临床适宜分离与检测技术开发、标准化与规范化质量体系构建、临床试验与产品监管审批等方面持续努力，从而促进EV检测技术在疾病诊断、疗效监测和预后判断中的应用和转化，推动检验医学更好服务人民健康。

Extracellular vesicles (EV), as novel disease biomarkers, have shown broad applicational prospect in the field of laboratory medicine or disease diagnosis. There have been substantial advancements in EV isolation technologies, EV biomarker screening and validation, and EV detection techniques. However, to fully integrate EV into clinical laboratories, ongoing efforts are needed in several areas including multi-omics integration and big data analysis, the development of clinically suitable technologies in isolation and detection, the establishment of standardized and normalization of quality systems, and the execution of clinical trials and administration and approvals of products, so as to promote the application and transformation of EV detection technologies in disease diagnosis, therapeutic evaluation, and prognosis assessment, thereby fostering better service of people's health in the aspect of laboratory medicine.