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An isotope dilution LC–MS/MS-based candidate reference method for the quantification of androstenedione in human serum and plasma

Authors :
Magdalena Mayer
Stephan Pongratz
Uwe Kobold
Andrea Geistanger
Christine Kleinschmidt
Christian Geletneky
Verena Hofmann
Daniel Köppl
Stefan Hutzler
Neeraj Singh
Judith Taibon
Manfred Rauh
Eva Albrecht
Katrin Gradl
Source :
Clinical Mass Spectrometry
Publication Year :
2020
Publisher :
Elsevier, 2020.

Abstract

Highlights • LC-MS/MS-based candidate reference method for the quantification of androstenedione. • Certified reference material from NMIA with additional qNMR characterization. • Uncertainty evaluation according to the GUM 1995. • Inter laboratory comparison study and comparison to a routine LC-MS/MS assay.<br />The accurate measurement of androstenedione in human serum and plasma is required for steroid profiling to assure the appropriate diagnosis and differential diagnosis of hyperandrogenism. In this work, we introduce an isotope dilution liquid chromatography–tandem mass spectrometry (LC–MS/MS) candidate reference measurement procedure for the quantification of androstenedione in human serum and plasma. The performance of the procedure enables its use in the evaluation and standardization of routine assays and for the evaluation of patient samples to ensure the traceability of individual patient results. As the primary standard, a certified reference material from NMIA (National Measurement Institute, Australia) was used. Additionally, a quantitative nuclear magnetic resonance (qNMR) method was developed for the value assignment of the primary reference material, which ensures the direct traceability to SI units, as well as the independence from the availability of reference materials. 13C3-labeled androstenedione was used as the internal standard. The introduced method allows the measurement of androstenedione in the range of 0.05–12 ng/mL, and the assay imprecision was found to be

Details

Language :
English
ISSN :
23769998 and 22138005
Volume :
16
Database :
OpenAIRE
Journal :
Clinical Mass Spectrometry
Accession number :
edsair.doi.dedup.....4ae885ed714196a46bc47d015e793cf0