Background: Liquid chromatography coupled with tandem mass spectrometry (LC- MS/MS) tends to overcome other methods for therapeutic drugs monitoring (TDM) due to its very good analytical performances. Nevertheless, the lack of automation still limits its use in laboratory medicine. The Cascadion SM Clinical Analyzer (Thermo Fisher Scientific) is the first fully automated LC-MS/MS instrument available. We evaluated its immunosuppressant drugs (ISD) assay and the incorporation of such instrument into a core-laboratory.
Methods: An extended analytical verification of the Cascadion ISD panel including cyclosporin A, tacrolimus, everolimus and sirolimus was performed. It was compared to the MassTox ISD assay (Chromsystems). Different preanalytical and analytical conditions were tested. Finally, a turnaround-time evaluation and a satisfaction survey of users after 11 months of use in a core-laboratory were performed.
Results: Precision and linearity results were within the analytical goals fixed. The comparison with the MassTox ISD assay showed results in agreement except for cyclosporin A where a bias of -11.6% was observed, probably due to a greater trueness of the Cascadion method. Additional experiments showed good performances. The random accessibility and the ease of use by non-specialized staff members allowed a wider working time range and a reduction of the turnaround-time of 55%.
Conclusion: The Cascadion ISD Panel held its promises in term of analytical performances, workflow aspects and ease of use by non-specialized staff.
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