Isotope-dilution-LC-MS/MS candidate reference measurement procedure for cefepime in human serum.

Content Provider	Europe PMC
Author	Schäffler, Judith Vogeser, Michael Habler, Katharina
Copyright Year	2024
Description	BackgroundReference measurement procedures are an essential element in the standardization and comparability of analytical measurement results in laboratory medicine. No LC-MS/MS-based reference measurement procedure for cefepime in serum has been published previously.Materials and methodsAn isotope-dilution based two-dimensional LC-MS/MS reference measurement procedure for cefepime concentrations in human serum was developed and tested. The value assignment of unknown samples is based on a defined measurement series validation. Six unknown samples can be measured per series. Pass criteria for the run and the samples were determined empirically based on a performance evaluation. For this purpose, a between-run determination of five runs of the defined measurement series with six cefepime samples was carried out and evaluated. The goal was to define rigorous, realistic target limits and minimize measurement uncertainty. The final defined target limits are used for series-based validation and value assignment. The results for the six unknown samples are provided with the associated measurement uncertainty for this series.ResultsThe developed and extensively studied measurement procedure for the quantification of cefepime in serum was found to be practicable and fit for its purpose. The between-run mean imprecision of the six cefepime samples was ≤ 2.0 %, for the QCs it was ≤ 2.3 % and the between-run mean inaccuracy of the QCs was within ± 1.1 %.ConclusionThe novel isotope-dilution-LC-MS/MS measurement procedure in accordance to ISO 15193 can be recommended as candidate reference measurement procedure for the value assignment of cefepime concentrations in human serum. Highlights•Novel candidate ID-LC-MS/MS reference measurement procedure for cefepime in serum.•Transparent, traceable value assignment of cefepime samples.•A standardized Excel-tool for value assignment was used.
Related Links	https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC11396040&blobtype=pdf
ISSN	26671468
Volume Number	33
DOI	10.1016/j.jmsacl.2024.08.001
PubMed Central reference number	PMC11396040
PubMed reference number	39279891
Journal	Journal of Mass Spectrometry and Advances in the Clinical Lab [J Mass Spectrom Adv Clin Lab]
e-ISSN	2667145X
Language	English
Publisher	Elsevier
Publisher Date	2024-08-08
Access Restriction	Open
Rights License	This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). © 2024 THE AUTHORS. Publishing services by ELSEVIER B.V. on behalf of MSACL.
Subject Keyword	Cefepime Isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) Reference measurement procedures Metrological traceability Standardization
Content Type	Text
Resource Type	Article
Subject	Spectroscopy Clinical Biochemistry Medical Laboratory Technology Microbiology