Stable Isotope-Dilution-LC-MS/MS-based Reference Methods – Suggestion for Description of Methods and Structure of Analytical Series
Michael Vogeser (1), Carina Schuster (1), Christina Ritter-Sket (2). Anja Kessler (2) (1) University Hospital, LMU Munich, Institute of Laboratory Medicine, Munich, Germany (2) Referenzinstitut für Bioanalytik), Bonn, Germany
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Michael Vogeser (Presenter) University Hospital, LMU Munich
Presenter Bio: Professor of Laboratory Medicine at the LMU Munich and Senior Physician at the University Hospital. Co-Editor-in-Chief of CMS. Secretary of the German Association of Clinical Chemistry and Laboratory Medicine.
Relevant Financial Disclosures
(within past 24 months)
No relevant financial relationship(s) to disclose.
Abstract
ID-LC-MS/MS methods are increasingly used as reference for routine methods, but actually the characteristics of such reference methods (RM) are so far not conclusively specified. A RM concept specifically for ID-LC/MS was developed, including three key elements: 1. Standardized method description – differentiating between essential characteristics (such as recorded mass transitions) and variable features that realistically can not be standardized over time (such as lot of columns). 2. Standardized structure of analytical series, including several features for performance verification (e.g., addressing matrix effects). 3. Based on this, a series-related validation concept according to pre-defined criteria as essential characteristic of the RM. This novel approach was successfully applied to a RM for the quantification of linezolid in serum.
= Discovery stage.
= Translation stage.
= Clinically available.
