Clinical Mass Spectrometry in Immunosuppressant Analysis: Toward a Full Automation?

The analysis of immunosuppressive drugs allows the physician to monitor, and eventually correct, immunosuppressive therapy. The panel of molecules under evaluation includes cyclosporine A (CsA), tacrolimus, sirolimus, and everolimus. Initially, assays were performed by immunometric methods, but in t...

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Bibliographic Details
Main Authors: Albertario, M. (Author), Bagnati, M. (Author), Dianzani, U. (Author), Fania, C. (Author), Ferraris, C. (Author), Lamonaca, M. (Author)
Format: Article
Language:English
Published: MDPI 2022
Subjects:
TDM
Online Access:View Fulltext in Publisher
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008 220510s2022 CNT 000 0 und d
020 |a 20763417 (ISSN) 
245 1 0 |a Clinical Mass Spectrometry in Immunosuppressant Analysis: Toward a Full Automation? 
260 0 |b MDPI  |c 2022 
856 |z View Fulltext in Publisher  |u https://doi.org/10.3390/app12073695 
520 3 |a The analysis of immunosuppressive drugs allows the physician to monitor, and eventually correct, immunosuppressive therapy. The panel of molecules under evaluation includes cyclosporine A (CsA), tacrolimus, sirolimus, and everolimus. Initially, assays were performed by immunometric methods, but in the past few years this methodology has been largely superseded by a more accurate and specific technique, liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS), which is now considered the “gold standard” for immunosuppressant analysis. Both LC-MS/MS and often also immunoassays require a preanalytical manual sample preparation, which involves time-consuming sequential operations whose traceability is often hampered and adds up to the probability of gross errors. The aim of this work was to compare an “open” LC-MS/MS with a fully automated system, consisting of LC instrumentation combined with a triple quadrupole MS, named Thermo Scientific™ Cascadion™ SM Clinical Analyzer (Cascadion). Such automated systems suit the requirements of the reference method and are designed to completely eliminate all of the manual procedures. More than 2000 immunosuppressant samples were analyzed both with the open LC-MS/MS and with Cascadion. Statistics allowed the evaluation of linearity, intra-and inter-assay CV%, bias %, limit of detection and of quantitation, and Passing–Bablok and Bland–Altman plots. Results indicated a good correlation between the two methods. In both cases, methods confirmed their suitability for diagnostic settings. Cascadion could provide support when the presence of specialized personnel is lacking, and/or when great productivity and continuous workflow are required. © 2022 by the authors. Licensee MDPI, Basel, Switzerland. 
650 0 4 |a automation 
650 0 4 |a LC-MS/MS 
650 0 4 |a TDM 
700 1 |a Albertario, M.  |e author 
700 1 |a Bagnati, M.  |e author 
700 1 |a Dianzani, U.  |e author 
700 1 |a Fania, C.  |e author 
700 1 |a Ferraris, C.  |e author 
700 1 |a Lamonaca, M.  |e author 
773 |t Applied Sciences (Switzerland)