Dirks Niek F, Ackermans Mariëtte T, Martens Frans, Cobbaert Christa M, de Jonge Robert, Heijboer Annemieke C
Amsterdam UMC, Vrije Universiteit Amsterdam, Endocrine Laboratory, Department of Clinical Chemistry, Amsterdam Gastroenterology & Metabolism, Amsterdam, Netherlands.
Amsterdam UMC, University of Amsterdam, Endocrine Laboratory, Department of Clinical Chemistry, Amsterdam, Netherlands.
Clin Chim Acta. 2021 Mar;514:80-83. doi: 10.1016/j.cca.2020.12.020. Epub 2020 Dec 22.
With the upcoming EU regulation on the use of in-vitro diagnostic devices, a critical evaluation of the current status of our in-house developed LC-MS/MS methods is timely and of great relevance. Recently, much attention has been devoted to the need for better specification of analytical and clinical performance. Appropriate reporting of the actual achieved analytical performance is an important determinant of the clinical performance and subsequent clinical effectiveness of a test. We advocate for the application of CLSI C62-A guidelines for method validation and suggest some adaptations for analytical validation of in-house developed LC-MS/MS methods for endogenous substances. Additionally, we underline the importance of well-equipped reviewers and standardized method description, including the presentation of figural evidence of obtained method performance. Achieving this ensures future quality of our in-house developed LC-MS/MS methods.
随着即将出台的欧盟体外诊断设备使用法规，对我们内部开发的液相色谱-串联质谱（LC-MS/MS）方法的现状进行批判性评估既及时又具有重大意义。最近，人们非常关注对分析性能和临床性能进行更完善规范的必要性。准确报告实际达到的分析性能是一项检测临床性能及后续临床有效性的重要决定因素。我们主张应用临床和实验室标准协会（CLSI）C62-A指南进行方法验证，并针对内部开发的用于内源性物质的LC-MS/MS方法的分析验证提出一些调整建议。此外，我们强调配备完善的评审人员和标准化方法描述的重要性，包括展示所获方法性能的图形证据。做到这一点可确保我们内部开发的LC-MS/MS方法的未来质量。
