Lack of analytical interference of dydrogesterone in progesterone immunoassays

Tanja K. Eggersmann; Albert Wolthuis; Peter H. van Amsterdam; Georg Griesinger

doi:10.1515/cclm-2022-0174

Article

Lack of analytical interference of dydrogesterone in progesterone immunoassays

Tanja K. Eggersmann , Albert Wolthuis , Peter H. van Amsterdam and Georg Griesinger

Published/Copyright: May 11, 2022

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 60 Issue 7

Abstract

Objectives

Progesterone, a sex steroid, is measured in serum by immunoassay in a variety of clinical contexts. One potential limitation of steroid hormone immunoassays is interference caused by compounds with structural similarity to the target steroid of the assay. Dydrogesterone (DYD), an orally active stereoisomer of progesterone, is used for various indications in women’s health. Herein, we report a systematic in vitro investigation of potential interference of DYD and its active metabolite 20α-dihydrodydrogesterone (DHD) in seven widely used, commercially available progesterone assays.

Methods

Routine human plasma samples were anonymized and pooled to create three graded concentration levels of progesterone (P4 high, P4 medium, P4 low). Each pooled P4 plasma sample (6–7 mL) was spiked at high, medium, and “none” concentration with DYD/DHD and was divided into 0.5 mL aliquots. The blinded aliquots were analyzed by seven different laboratories with their routine progesterone assay (six different immunoassays and one liquid chromatography–tandem mass spectrometry assay, respectively) within the Dutch working group on endocrine laboratory diagnostics of the Dutch Foundation for Quality Assessments in Medical Laboratories.

Results

The sample recovery rate (P4 result obtained for sample spiked with DYD/DHD, divided by the result obtained for the corresponding sample with no DYD/DHD × 100) was within a ±10% window for the medium and high P4 concentrations, but more variable for the low P4 samples. The latter is, however, attributable to high inter- and intra-method variability at low P4 concentrations.

Conclusions

This study does not indicate any relevant interference of DYD/DHD within routinely used progesterone assays.

Keywords: α-dihydrodydrogesterone; cross-reaction; Duphaston; dydrogesterone; interference; progesterone immunoassay

Corresponding author: Albert Wolthuis, Stichting Certe Medische Diagnostiek en Advies, Van Swietenlaan 2, 9728 NZ Groningen, the Netherlands, Phone: +31 58 2888455, Fax +31 58 2882227, E-mail: a.wolthuis@certe.nl

Acknowledgments

We thank all participating laboratories in the Netherlands for technical support: Advia Centaur (Siemens Healthineers), Laboratory for Clinical Chemistry and Hematology, Jeroen Bosch Ziekenhuis, Den Bosch, (Dr. R.M.J. Hoedemakers); Atellica (Siemens Healthineers), Laboratory for Clinical Chemistry and Hematology, Ziekenhuis Gelderse Vallei, Ede (Dr. S.C. Endenburg); Architect (Abbott Laboratories), Franciscus laboratorium en trombosedienst, Franciscus Gasthuis en Vlietland, Rotterdam (Dr. Agilent), department FA Lindeboom); Cobas 801 (Roche), Laboratory for clinical chemistry, Stichting Certe MDA location MCL, Leeuwarden (Dr. H. de Wit), DXi (Beckman Coulter), Laboratory for ClinicalChemistry and Hematology, University Medical Center Utrecht location AZU, Utrecht (Dr. E.G.W.M. Lentjes); Immulite 2000 XPi (Siemens Healthineers), Central Diagnostic Laboratory, Maastricht University Medical Center, Maastricht (Dr. J.A.P. Bons); LC-MS/MS (Laboratory Medicine, Radboud University Medical Center, Nijmegen (Dr. A.E. van Herwaarden).

Research funding: The research had no substantial funding. Materials were provided by Abbott (standards) and CERTE (plasma pools). Sample analysis costs, when applicable, were covered by Abbott.
Author contribution: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: T.K.E has received honoraria and/or non-financial support from Ferring and Merck. A.W. has received honoraria from Siemens Healthineers. P.v.A. is an employee of Abbott. G.G. has received honoraria and/or non-financial support (e.g., travel cost compensation) from Abbott, Ferring, Gedeon Richter, Guerbet, Merck, Organon, MSD, ObsEva, PregLem, ReprodWissen GmbH, Vifor, and Cooper.
Informed consent: Not applicable.
Ethical approval: Not applicable.
Data availability: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Received: 2022-02-25

Accepted: 2022-04-06

Published Online: 2022-05-11

Published in Print: 2022-06-27

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https://doi.org/10.1515/cclm-2022-0174

Keywords for this article

α-dihydrodydrogesterone; cross-reaction; Duphaston; dydrogesterone; interference; progesterone immunoassay