Industry workshop - ROCHE

29 September 2026

Workshop

• IW03 • 13:00 > 13:25 • Industry workshop - ROCHE • Carré 1

Standardisation Journey of the cobas® Mass Spec Gentamicin Assay

Elie Fux, PhD; R&D Manager, Roche Diagnostics GmbH, Penzberg, Germany

Standardization of liquid chromatography–tandem mass spectrometry (LC-MS/MS) assays to reference measurement procedures (RMPs) in accordance with ISO 17511:2020 is critical for routine therapeutic drug monitoring. In this workshop, we will explore the metrological challenges behind the standardization of therapeutic drug monitoring assays and, in particular, the journey toward SI-traceable measurement of gentamicin.

Gentamicin is a potent aminoglycoside antibiotic with a narrow therapeutic index, comprising a mixture of distinct congeners (C1, C1a, C2, C2a, and C2b). Historically, primary calibrators for gentamicin have been assigned using reference materials defined by biological activity in International Units (IU) via microbial cylinder-plate assays rather than mass-based SI units. So, what happens when we move from biological activity to an SI-based calibration approach ?

During the workshop, we will discuss:

Why gentamicin presents a particular challenge for metrological traceability

What changes when primary calibration moves from biological activity to SI-traceable mass units

How qNMR can contribute to the calibration chain

How to separate analytical effects from metrological effects

How a candidate isotope-dilution LC-MS/MS reference measurement procedure compares with a JCTLM-listed reference method

What these approaches mean for harmonization of routine mass spectrometry across laboratories and platforms

Join us to explore how a robust measurement framework can improve comparability and confidence in gentamicin therapeutic drug monitoring and contribute to global harmonization.

Disclaimer: The cobas® i 601 analyzer and a selection of Ionify® analytes are CE-marked. Further Ionify reagents are currently under development. Availability and regulatory status vary by country. COBAS and IONIFY are trademarks of Roche. All other product names and trademarks are the property of their respective owners.

Research funding: This research was funded by Roche Diagnostics GmbH.