MSACL 2019 EU Abstract

Methodological Traceability: Standardized Description of LC-MS-based Measurement Methods in Laboratory Medicine

Carina Schuster (1), Alan Rockwood (2), Michael Vogeser (1)
(1) Institute of Laboratory Medicine, University Hospital, LMU Munich, Germany, (2) Rockwood Scientific Consulting, Salt Lake City, USA

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Carina Schuster (Presenter) LMU Munich

Relevant Financial Disclosures (within past 24 months) No relevant financial relationship(s) to disclose. Conflict mitigation NOT REQUIRED.

OBJECTIVE: Many detailed guidelines for LC-MS method development are available and well known in the literature. However, the description of the method itself is hardly standardized. Particularly in the field of LC-MS, many variables like different manufacturers and day-to-day or even hour-to-hour variability of instruments have to be considered.
We suggest a standardized approach to the description of LC-MS/MS methods in clinical application as an oral presentation in the Scientific Session 1 (Quality Control) of this conference.
In this concept we suggest differentiating between fundamental and variable characteristics. Fundamental characteristics define the identity of a method and can be standardized between different laboratories and over longer periods: for example, ionization mode (e.g. positive electrospray ionization), main column chemistry like C18 or internal standard compound(s), including labelling pattern. On the other hand, variable characteristics cannot be standardized over time and space: for example, lots of column or solvents, MS instrument manufacturer, as well as ion source geometry or vacuum conditions.
With a companion poster presentation, we aim to exemplify the application of this suggested standard for a representative TDM method.

METHODS: The herein described novel approach was applied for the description of a LC-MS method for the quantification of linezolid in human serum. To highlight the consistency between two different systems across fundamental and variable characteristics, we implemented the method on an Acquity UPLC coupled to a Xevo TQ-S from Waters and an Agilent 1290 Inifnity II coupled to an AB Sciex QTrap 6500+.

CONCLUSION: The suggested approach was found to be a good tool facilitating standardization in the description of LC-MS/MS methods. Notably, variations in fundamental and variable characteristics of both described systems indicate the importance of standardized technical description.