The process of method development for a diagnostic assay based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) involves several disparate technologies and specialties. Additionally, method development details are typically not disclosed in journal publications. Method developers may need to search widely for pertinent information on their assay(s). This review summarizes the current practices and procedures in method development. Additionally, it probes aspects of method development that are generally not discussed, such as how exactly to calibrate an assay or where to place quality controls, using examples from the literature. This review intends to provide a comprehensive resource and induce critical thinking around the experiments for and execution of developing a clinically meaningful LC-MS/MS assay.

中文翻译：

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液相色谱-串联质谱在临床实验室中的应用回顾：第一部分-开发。

基于液相色谱-串联质谱 (LC-MS/MS) 的诊断分析方法开发过程涉及多种不同的技术和专业。此外，方法开发的细节通常不会在期刊出版物中披露。方法开发人员可能需要广泛搜索有关其检测的相关信息。本综述总结了方法开发中的当前实践和程序。此外，它使用文献中的示例探讨了通常不讨论的方法开发方面，例如如何准确校准测定或放置质量控制的位置。本综述旨在提供全面的资源，并引发围绕实验和执行开发具有临床意义的 LC-MS/MS 测定的批判性思维。