After another decade: LC–MS/MS became routine in clinical diagnostics

• Published in: Clinical biochemistry Vol. 82; pp. 2 - 11
• Main Authors: Seger, Christoph, Salzmann, Linda
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2020
• Subjects: Automation, Laboratory - methods; Chromatography, Liquid - trends; Diagnostic Tests, Routine - trends; Drug Monitoring - methods; Endocrinology; Endocrinology - methods; Forecasting; Humans; Laboratory automation; LC–MS/MS; Mass spectrometry; Tandem Mass Spectrometry - trends; TDM; Toxicology; Toxicology - methods; Toxicology; Laboratory automation; TDM; Mass spectrometry; LC–MS/MS; Endocrinology
• ISSN: 0009-9120; 1873-2933; 1873-2933
• DOI: 10.1016/j.clinbiochem.2020.03.004

•The application of mass spectrometry in clinical routine is discussed.•An overview of instrument and platform improvement is given.•Legal boundaries of lab developed tests are presented.•Recent initiatives for Information mitigation and education are summarized. Tandem mass spectrometry – especially in combination with liquid chromatography (LC–MS/MS) – is applied in a multitude of important diagnostic niches of laboratory medicine. It is unquestioned in its routine use and is often unreplaceable by alternative technologies. This overview illustrates the development in the past decade (2009–2019) and intends to provide insight into the current standing and future directions of the field. The instrumentation matured significantly, the applications are well understood, and the in vitro diagnostics (IVD) industry is shaping the market by providing assay kits, certified instruments, and the first laboratory automated LC–MS/MS instruments as an analytical core. In many settings the application of LC–MS/MS is still burdensome with locally lab developed test (LDT) designs relying on highly specialized staff. The current routine applications cover a wide range of analytes in therapeutic drug monitoring, endocrinology including newborn screening, and toxicology. The tasks that remain to be mastered are, for example, the quantification of proteins by means of LC–MS/MS and the transition from targeted to untargeted omics approaches relying on pattern recognition/pattern discrimination as a key technology for the establishment of diagnostic decisions.