Lecture

cobasⓇ Mass Spec for therapeutic drug monitoring – an initial experience report

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  • ICM Saal 5
  • Type: Lecture

Lecture description

Background: Therapeutic drug monitoring (TDM) is a cornerstone of precision pharmacotherapy for drugs with e.g., narrow therapeutic windows and high interindividual pharmacokinetic variability. Thus, linking TDM with clinical response and toxicity risk, it supports individualized dosing and improves the likelihood of achieving therapeutic targets, particularly in complex settings such as critical illness, polypharmacy, and organ dysfunction [1, 2].


Objective: To describe initial hands-on experience with the cobas® Mass Spec solution (cobas® i 601 analyzer with Ionify® reagent packs) for TDM, focusing on workflow automation, analytical performance considerations, implications for routine diagnostics compared with conventional laboratory-developed LC-MS/MS methods as well as potential limitations.

Methods/ Approach: We mapped end-to-end TDM processes on cobas® Mass Spec (sample handling, preparation, measurement, and result generation) and compared them with conventional LC-MS/MS workflows, focusing on antiepileptic drugs like
lamotrigine and defined antibiotics. Compared to conventional LC-MS/MS (characterized by multi-vendor components, manual/semi-manual sample preparation, and intensive method maintenance), cobas® Mass Spec is expected to (i) increase automation and throughput consistency, (ii) improve standardization across sites, and (iii) streamline routine operation and training requirements [3, 4].

Preliminary Results/ Findings: In the first step a direct method comparison is done for the antiepileptic drug lamotrigine (frequently specified reference range ~3–15 mg/L) and the β-lactam antibiotics meropenem and piperacillin, where TDM-guided dosing
has been extensively studied in critically ill populations [5, 6].

Outlook: Anticipated limitations include dependence on the commercial assay menu, constraints in method customization compared with LDT LC-MS/MS, and the continued need to evaluate comparability when transitioning methods. The primary endpoints will be precision and trueness across clinically relevant therapeutic ranges to assess suitability for routine patient care.

Literature:
[1] Emerging therapeutic drug monitoring technologies and applications. Front Pharmacol. 2024.
[2] Overview of therapeutic drug monitoring and clinical practice. SciDirect. 2023.
[3] Roche transforms mass spectrometry diagnostics with launch of cobas® Mass Spec solution (CE mark). Roche. 2024 Dec 18.
[4] Roche cobas® Mass Spec: overall concept white paper (automation, integration, standardization). Roche.
[5] Lamotrigine. In: Baselt RC et al. Disposition of Toxic Drugs and Chemicals in Man. 12th ed. Thieme.
[6] Beta-lactam antibiotic TDM in critically ill patients: systematic review and meta-analysis. Clin Infect Dis. 2022.

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