Comprehensive Guide to LC-MS/MS Method Development for Clinical Diagnostic Assays
This first-of-two-part review provides a thorough resource for developing clinically meaningful LC-MS/MS assays, covering calibration strategy, quality control placement, internal standard selection, and matrix considerations. Method development details typically absent from journal publications are discussed with practical examples. The review is designed to guide both novice and experienced practitioners through the complex process of building a diagnostic mass spectrometry assay from the ground up.
The original study
Review of the Use of Liquid Chromatography-Tandem Mass Spectrometry in Clinical Laboratories: Part I-Development.
- Authors
- Rappold BA
- Journal
- Annals of laboratory medicine
- Type
- Journal Article, Review
- PMID
- 34635606
Original abstract
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.