液相色谱串联质谱临床检测方法的开发与验证.pdfVIP

检验医学2019 年3 月第34 卷第3 期 Laboratory Medicine ，March 2019 ，Vol. 34 ，No. 3 ·189 · 文章编号 ：1673-8640 （2019 ）03-0189-08 中图分类号：R446.1 文献标志码 ：A DOI ：10.3969/j.issn.1673-8640.2019.03.001 液相色谱串联质谱临床检测方法的开发与验证 中国医师协会检验医师分会临床质谱检验医学专业委员会 摘要：液相色谱串联质谱（LC-MS/MS ）是近年来发展极为迅速的新技术。该技术结合了液相色谱的高 分离性能和质谱的高敏感性、高特异性等优势，被广泛应用于化工、生物、医药、食品、临床医学、环境等 领域。在临床检验和诊断领域，LC-MS/MS作为传统诊断技术的补充，可提供更为准确、可靠的依据，使许多 疾病得到准确、快速的诊断。文章结合目前已公布的LC-MS/MS方法相关验证指南、文献及实际操作经验，系 统介绍了LC-MS/MS方法开发的关键流程，并以25-羟基维生素D [25 （OH ）D ]为实例介绍方法验证的关键要 3 3 素，为LC-MS/MS技术临床应用方法的建立、验证和实施提供参考。 关键词：液相色谱串联质谱；方法开发；方法验证 Consensus of method development and validation of liquid chromatography-tandem mass spectrometry in clinical laboratories Clinical Mass Spectrometry Committee ，Chinese Medical Doctor Association of Laboratory Medicine. Abstract ：Liquid chromatography-tandem mass spectrometry （LC-MS/MS ） is an emerging technology which has developed rapidly in recent years. It has combined the separation properties of liquid chromatography and the high sensitivity and specificity of mass spectrometry ，which is widely applied in various areas ，such as chemistry ，biology ，pharmaceutical science ，food ，clinic and environmental science. Especially in the field of clinical laboratory and diagnostics ，LC-MS/MS used as a complement to traditional diagnostic techniques can often provide more accurate and reliable testing results in accurate and rapid diagnosis of diseases. In this review ，some internationally published LC-MS/MS method validation guidelines ，related literature and practical experience were summarized ，and some key processes of LC-MS/MS development were introduced. Using 25-hydroxyvitamin D3 [25 （OH ）D ] as an example ，the key elements of method validation were reviewed ，in ord