Automated LC-MS/MS: Ready for the clinical routine Laboratory?

Background: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is a sensitive method with high specificity. However, its routine use in the clinical laboratory is hampered by its high complexity and lack of automation. Studies demonstrate excellent analytical performance using the first fully automated LC-MS/MS for 25-hydroxy vitamin D and immunosuppressant drugs (ISD) in hospital routine laboratories.Objectives: Our objectives were (1) to verify the suitability of an automated LC-MS/MS in a commercial labo-ratory, which differs from the needs of hospital laboratories, and (2) examine its usability among operators with various professional backgrounds.Methods: We assessed the analytical assay performance for vitamin D and the ISDs cyclosporine A and tacrolimus over five months. The assays were compared to an identical analyzer in a hospital laboratory, to in-house LC-MS/ MS methods, and to chemiluminescent microparticle immunoassays (CMIA). Nine operators evaluated the us-ability of the fully automated LC-MS/MS system by means of a structured questionnaire.Results: The automated system exhibited a high precision (CV < 8%), accuracy (bias < 7%) and good agreement with concentrations of external quality assessment (EQA) samples. Comparable results were obtained with an identical analyzer in a hospital routine laboratory. Acceptable median deviations of results versus an in-house LC-MS/MS were observed for 25-OH vitamin D3 (-10.6%), cyclosporine A (-4.3%) and tacrolimus (-6.6%). The median bias between the automated system and immunoassays was only acceptable for 25-OH vitamin D3 (6.6%). All users stated that they had had a good experience with the fully automated LC-MS/MS system.Conclusions: A fully automated LC-MS/MS can be easily integrated for routine diagnostics in a commercial laboratory.