Report from the HarmoSter study: impact of calibration on comparability of LC-MS/MS measurement of circulating cortisol, 17OH-progesterone and aldosterone
Open accessAbstract
Objectives: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is recommended for measuring circulating steroids. However, assays display technical heterogeneity. So far, reproducibility of corticosteroid LC-MS/MS measurements has received scant attention. The aim of the study was to compare LC-MS/MS measurements of cortisol, 17OH-progesterone and aldosterone from nine European centers and assess performance according to external quality assessment (EQA) materials and calibration. Methods: Seventy-eight patient samples, EQA materials and two commercial calibration sets were measured twice by laboratory-specific procedures. Results were obtained by in-house (CAL1) and external calibrations (CAL2 and CAL3). We evaluated intra and inter-laboratory imprecision, correlation and agreement in patient samples, and trueness, bias and commutability in EQA materials. Results: Using CAL1, intra-laboratory CVs ranged between 2.8–7.4%, 4.4–18.0% and 5.2–22.2%, for cortisol, 17OH-progesterone and aldosterone, respectively. Trueness and bias in EQA materials were mostly acceptable, however, inappropriate commutability and target value assignment were highlighted in some cases. CAL2 showed suboptimal accuracy. Median inter-laboratory CVs for cortisol, 17OH-progesterone and aldosterone were 4.9, 11.8 and 13.8% with CAL1 and 3.6, 10.3 and 8.6% with CAL3 (all p<0.001), respectively. Using CAL1, median bias vs. all laboratory-medians ranged from −6.6 to 6.9%, −17.2 to 7.8% and −12.0 to 16.8% for cortisol, 17OH-progesterone and aldosterone, respectively. Regression lines significantly deviated from the best fit for most laboratories. Using CAL3 improved cortisol and 17OH-progesterone between-method bias and correlation. Conclusions: Intra-laboratory imprecision and performance with EQA materials were variable. Inter-laboratory performance was mostly within specifications. Although residual variability persists, adopting common traceable calibrators and RMP-determined EQA materials is beneficial for standardization of LC-MS/MS steroid measurements.
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The paper found weak correlation or partial positive correlation for hormone circadian oscillations between glucocorticoids and gonadal hormones.
“As stated above, we found weak correlation or partial positive correlation for hormone circadian oscillations; see e.g. [114–116].”
From Fibromyalgia pathogenesis explained by a neuroendocrine multistable model (2024) · cites this paper as [114]
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Self-citation
- Authors
- Fanelli, F., Cantù, M., Temchenko, A., Mezzullo, M., Lindner, J. M., Peitzsch, M., Hawley, J. M., Bruce, S., Binz, P.-A., Ackermans, M. T., Heijboer, A. C., Van den Ouweland, J., Koeppl, D., Nardi, E., MacKenzie, F., Rauh, M., Eisenhofer, G., Keevil, B. G., Vogeser, M., & Pagotto, U.
- Affiliations
- IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT)
- Ente Ospedaliero Cantonale (CH)
- Institut für Laboratoriumsmedizin (DE)
- University Hospital Carl Gustav Carus (DE)
- Manchester University NHS Foundation Trust (GB)
- Centre Hospitalier Universitaire Vaudois (CH)
- Department of Clinical Chemistry , Endocrine Laboratory, Amsterdam UMC, University of Amsterdam , Amsterdam , The Netherlands
- Amsterdam University Medical Centers (NL)
- Department of Clinical Chemistry , Canisius-Wilhelmina Hospital , Nijmegen , The Netherlands
- Universitätsklinikum Erlangen (DE)
- University of Bologna (IT)
- University Hospitals Birmingham NHS Foundation Trust (GB)
- Corresponding author
- Fanelli, Flaminia
- ORCID
- Venue
- Clinical Chemistry and Laboratory Medicine (CCLM)
- Publisher
- Walter de Gruyter GmbH
- Published
- 2022-02-16
- Volume
- 60
- Issue
- 5
- Pages
- 726-739
- ISSN
- 1434-6621 (ISSN-L)
- 1437-4331
- OpenAlex
- W4213201955
- Cited by
- 36
- References
- 35
- Citations by year
- 2026: 7 · 2025: 8 · 2024: 8 · 2023: 8 · 2022: 5
- FWCI
- 4.51
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Clinical Chemistry and Laboratory Medicine (CCLM) (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion, other-oa)
- SERVAL (Université de Lausanne) (publishedVersion, cc-by)
- Pure Amsterdam UMC (acceptedVersion, cc-by)
- UvA-DARE (University of Amsterdam) (submittedVersion, cc-by)
- IRIS (submittedVersion, cc-by)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion, cc-by)
- Funders
- Deutsche Forschungsgemeinschaft (CRC/TRR 205, 501100001659, TRR205, 314061271, 10.13039/501100001659, TRR 205/1, CRC/TRR 205/1, 205/1)
- Regione Emilia-Romagna (PRUA 1-2012-004)
- Topics
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Scientific Measurement and Uncertainty Evaluation
- Keywords
- LC-MS/MS, corticosteroid measurement, cortisol, 17-hydroxyprogesterone, aldosterone, assay calibration, external quality assessment, interlaboratory comparability, measurement reproducibility, commutability, bias
- MeSH terms
- Aldosterone, Calibration, Chromatography, Liquid, Humans, Hydrocortisone, Progesterone, Reproducibility of Results, Tandem Mass Spectrometry
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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