期刊
ANNALS OF LABORATORY MEDICINE
卷 42, 期 2, 页码 121-140出版社
KOREAN SOC LABORATORY MEDICINE
DOI: 10.3343/alm.2022.42.2.121
关键词
Tandem Mass Spectrometry; Liquid Chromatography; Method Development; Sample Preparation; Calibration; Internal Standards; Matrix Effects; Quality Control
This review summarizes the current practices and procedures in method development for a diagnostic assay based on liquid chromatography-tandem mass spectrometry (LC-MS/MS), and explores aspects that are generally not discussed, providing a comprehensive resource and inducing critical thinking for the development of clinically meaningful LC-MS/MS assays.
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.
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