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首页> 外文期刊>Journal of mass spectrometry: JMS >Challenges in implementing clinical liquid chromatography-tandem mass spectrometry methods - seeing the light at the end of the tunnel
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Challenges in implementing clinical liquid chromatography-tandem mass spectrometry methods - seeing the light at the end of the tunnel

机译：实施临床液相色谱-串联质谱法的挑战-看到隧道尽头的光

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摘要

The use of liquid chromatography-tandem mass spectrometry (LC-MS/MS) in the clinical setting is a relatively new application. One of the significant barriers hampering the transition of LC-MS/MS from the research lab into a clinical setting is the uncertainty of how to successfully develop and validate a method that meets guidelines for clinical applications. Here, we have taken this seemingly overwhelming process and broken it into five general stages for consideration: assessing the clinical validity of a new LC-MS/MS assay, determination of feasibility, assay development, assay validation and post-implementation monitoring. Although various publications are available and serve as resources for determining development processes and acceptability criteria for specific LC-MS/MS assays, many of them are general recommendations or are specific to research applications that may not translate either practically or clinically. In this perspective special feature article, a resource is compiled that describes key differences between LC-MS/MSmethods for research use versus clinical use. In addition, the challenges facing the expanding role of this technique in the clinical setting are discussed, including instrumentation/automation challenges, potential regulation of laboratory developed tests by the US Food and Drug Administration and standardization and harmonization of MS methods through the use of traceable materials and availability of guidance documents.
机译：在临床环境中使用液相色谱-串联质谱（LC-MS / MS）是一个相对较新的应用。阻碍LC-MS / MS从研究实验室过渡到临床环境的重要障碍之一是如何成功开发和验证一种符合临床应用指南的方法尚不确定。在这里，我们采用了这个看似不堪重负的过程，并将其分为五个总体阶段进行考虑：评估新LC-MS / MS测定的临床有效性，确定可行性，测定开发，测定验证和实施后监测。尽管可以获得各种出版物，并且可以作为确定特定LC-MS / MS分析的开发过程和可接受性标准的资源，但其中许多是一般性建议，或者特定于可能无法在实践或临床上进行翻译的研究应用。在此观点的专题文章中，汇集了资源，描述了用于研究用途与临床用途的LC-MS / MS方法之间的关键区别。此外，还讨论了该技术在临床环境中不断扩展的作用所面临的挑战，包括仪器/自动化挑战，美国食品和药物管理局对实验室开发的测试的潜在监管以及通过使用可追溯的方法对MS方法进行标准化和统一指导文件的材料和可用性。

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