= Discovery stage.
= Translation stage.
= Clinically available.
MSACL 2019 EU : Vogeser

MSACL 2019 EU Abstract

Self-Classified Topic Area(s): Quality Management & Standardization

A Proposal to Standardize the Description of LC-MS -based Measurement Methods in Laboratory Medicine

Michael Vogeser (1), Carina Schuster (1), Alan L. Rockwood (2)
(1) Hospital of the University of Munich (LMU), Munich, Germany, (2) Rockwood Scientific Consulting, Salt Lake City, Utah, USA


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 Michael Vogeser (Presenter)
Hospital of the University of Munich (LMU)

Presenter Bio: Professor of Laboratory Medicine at the LMU Munich and Ssnior physician at the Hosptial of the University. Co-Editor-in-Chief of Clinical Mass Spetrometry

Relevant Financial Disclosures (within past 24 months)
Honorarium/Expenses Roche Diagnostics
Grant/Research Support DGKL
Committee/Board/Advisory Board German Association of Clinical Chemistry and Laboratory Medicine

Abstract

Background: So far, most publications reporting mass spectrometry-based measurement methods intended for diagnostic use describe in detail the method realization in one individual laboratory site - showing a very limited level of abstraction

Methods: To overcome this limitation we suggest a standardized approach to reporting LC-MS based methods, differentiating between fundamental characteristics of a measurement method on the one hand; and variable characteristics on the other hand. In this concept, fundamental characteristics are those that can be essentially translated into separate realizations too - e.g. the mode of ionization (e.g., electrospray in positive polarity) or the m/z ratio of monitored ions. They are intended to define in their entirety the identity of a measurement method. In contrast, variable characteristics are those that cannot realistically be standardized over time and space – e.g. the lot of a chromatographic column or of solvents, or the instrument specific geometry of the ion source that is highly manufacturer dependent, as well as instrument tuning settings.

Results: We have developed a preliminary set of 35 fundamental characteristics – defining a measurement procedure generically; these also include well-defined essential system performance characteristics – e.g. the required mass resolution, or a signal readout for the lowest concentrated calibrant. Furthermore, we suggest a set of 15 variable characteristics – which should be documented for each individual implementation and analytical run to achieve methodological traceability of individual results.

Conclusion: We recommend this novel standardized approach to method description for discussion and evaluation in the community.