液相色谱-串联质谱在临床检验中的发展与展望  

Development and Prospect of Liquid Chromatography-Tandem Mass Spectrometry in Clinical Examination

作　　者：陈宁清 姜红强 夏建松 黄巧巧 严国飞 姚芦鹬 CHEN Ningqing;JIANG Hongqiang;XIA Jiansong;HUANG Qiaoqiao;YAN Guofei;YAO Luyu(Zhejiang Center of Medical Device Evaluation,Hangzhou Zhejiang 310009,China)

机构地区：[1]浙江省医疗器械审评中心,浙江杭州310009

出　　处：《中国医疗设备》2025年第3期154-159,共6页China Medical Devices

基　　金：浙江省药品监管科技计划项目(2024017)。

摘　　要：质谱技术因其高灵敏度、高特异性、重现性好,且兼具高通量、高效率的特点,尤其是液相色谱-串联质谱(Liquid Chromatography-Tandem Mass Spectrometry,LC-MS/MS)技术在临床检验中应用广泛,逐渐在临床检验中占据重要地位。本文简述了LC-MS/MS的主流结构组成和技术特点,再从应用、监管、发展和创新4个方面进行详细概述,指出了LC-MS/MS技术发展面临的机遇和挑战。最后展望了质谱技术的发展方向,指出随着研究的深入和广泛开展,可进一步促进其良性发展。Mass spectrometry technology has gradually assumed a significant position in the field of clinical testing.This is due to its characteristics such as high sensitivity,high specificity,good reproducibility,high throughput and high efficiency.In particular,liquid chromatography-tandem mass spectrometry(LC-MS/MS)technology,which embodies these qualities,has been widely applied in clinical testing.This paper commenced with a concise elucidation of the principal structural components and technical characteristics of LC-MS/MS.Subsequently,it comprehensively elaborated on four key aspects,namely,its application scenarios,regulatory aspects,development trends,and innovation frontiers.Moreover,it meticulously identified the opportunities and challenges encountered in the advancement of LC-MS/MS technology.Finally,the future development trajectory of mass spectrometry was forecasted.It was expounded that with the in-depth and extensive progression of research,the salutary development of mass spectrometry could be further propelled.

关 键 词：液相色谱-串联质谱 临床检验 质谱技术 体外诊断 高通量检测 遗传代谢病筛查 

分 类 号：R197.39[医药卫生—卫生事业管理]