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A survey on measurement and reporting of total testosterone, sex hormone-binding globulin and free testosterone in clinical laboratories in Europe

  • Nick Narinx ORCID logo , Jennifer Afrakoma Nyamaah ORCID logo , Karel David ORCID logo , Vera Sommers ORCID logo , Joeri Walravens ORCID logo , Tom Fiers ORCID logo , Bruno Lapauw ORCID logo , Brigitte Decallonne ORCID logo , Frank Claessens ORCID logo , Katleen Van Uytfanghe ORCID logo , Jaak Billen ORCID logo , Pieter Vermeersch ORCID logo , Dirk Vanderschueren ORCID logo and Leen Antonio ORCID logo EMAIL logo
Published/Copyright: March 12, 2025
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 8

Abstract

Objectives

To compare clinical laboratory workflows for the assessment of androgens in men, focusing on total testosterone (T), sex hormone-binding globulin (SHBG) and free T, in clinical laboratories throughout Europe.

Methods

An internet-based survey that included questions related to pre-analytical, analytical and post-analytical phases of androgen measurements was distributed between December 2022 and December 2023 by clinical laboratory/chemistry and endocrine societies. A total of 124 unique records from clinical laboratories in 27 European countries were analyzed.

Results

Pre-analytical requirements for total T are subject to improvement as less than half of clinical laboratories recommended adequate morning sampling time and/or sampling in a fasting state. Total T was predominantly quantified using enzyme-linked immunoassay (IA) on automated platforms, with only one in four centers using mass spectrometry (MS), while SHBG was exclusively measured by IA. Additionally, free T was used by a majority of clinical laboratories, mainly reported as approximation by calculation of free T (cFT) using the Vermeulen formula. Generally, age-stratification was the preferred means of reporting reference ranges for total T, SHBG and cFT. However, considerate variability was observed in reported lower and upper limits, leading to the necessity of interpreting test results against assay-specific reference ranges, thereby hindering comparability of results between clinical laboratories.

Conclusions

Our survey highlights significant inter-laboratory variability for the assessment of androgen status in men, implying non-commutability of clinical test results between different centers. In addition, we observed poor adherence to pre-analytical recommendations. These findings advocate for continued harmonization efforts of measurement procedures for SHBG and total/free T.

Keywords: free testosterone; male hypogonadism; sex hormone-binding globulin; survey; total testosterone
Corresponding author: Prof. Dr. Leen Antonio, Laboratory of Clinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven Herestraat 49 – Box 7003, 3000 Leuven, Belgium; and Department of Endocrinology, University Hospitals Leuven, Leuven, Belgium, E-mail:

Funding source: Fonds Wetenschappelijk Onderzoek

Award Identifier / Grant number: 11P9024N

Award Identifier / Grant number: 1800923N

Award Identifier / Grant number: T004321N

Acknowledgments

We thank all collaborating societies for their support and their kind help in the dissemination of this survey study. Furthermore, we thank all participating clinical laboratories for supplying survey data. We wish to convey a special thank you to Prof. Dr. Jean-Marc Kaufman and Prof. Dr. Frederick C. Wu (members of the BEED-ED Advisory Board) for their continuous support and to Dr. Giovanni Corona, Dr. Sjoerd A.A. van den Berg and Dr. Gido Snaterse for their help in disseminating the survey. Collaboration for this publication is based upon work from COST Action CA20119 Andronet, supported by COST (European Cooperation in science and technology, see http://www.cost.eu).

  1. Research ethics: This survey study, with internal reference number S66446, was approved by the Institutional Review Board, Ethics Committee Research UZ/KU Leuven. This study was conducted in accordance with the principles outlined in the Declaration of Helsinki.

  2. Informed consent: Not applicable.

  3. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors declare that this research was conducted independently, without any sponsorship or financial support from manufacturers or commercial firms. This study represents the authors’ unbiased and objective academic work. There are no conflicts of interest to disclose.

  6. Research funding: This work was funded by research grants from Research Foundation Flanders (FWO, T004321N, 1800923N, 11P9024N).

  7. Data availability: Data will be made available upon reasonable request.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2024-1237).

Received: 2024-10-23
Accepted: 2025-03-02
Published Online: 2025-03-12
Published in Print: 2025-07-28

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2024-1237
Keywords for this article
free testosterone; male hypogonadism; sex hormone-binding globulin; survey; total testosterone

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Setting analytical performance specification by simulation (Milan model 1b)
  4. Reviews
  5. Unveiling the power of R: a comprehensive perspective for laboratory medicine data analysis
  6. Clostebol detection after transdermal and transmucosal contact. A systematic review
  7. Opinion Papers
  8. A value-based score for clinical laboratories: promoting the work of the new EFLM committee
  9. Digital metrology in laboratory medicine: a call for bringing order to chaos to facilitate precision diagnostics
  10. Perspectives
  11. Supporting prioritization efforts of higher-order reference providers using evidence from the Joint Committee for Traceability in Laboratory Medicine database
  12. Clinical vs. statistical significance: considerations for clinical laboratories
  13. Genetics and Molecular Diagnostics
  14. Reliable detection of sex chromosome abnormalities by quantitative fluorescence polymerase chain reaction
  15. Targeted proteomics of serum IGF-I, -II, IGFBP-2, -3, -4, -5, -6 and ALS
  16. Candidate Reference Measurement Procedures and Materials
  17. Liquid chromatography tandem mass spectrometry (LC-MS/MS) candidate reference measurement procedure for urine albumin
  18. General Clinical Chemistry and Laboratory Medicine
  19. Patient risk management in laboratory medicine: an international survey to assess the severity of harm associated with erroneous reported results
  20. Exploring the extent of post-analytical errors, with a focus on transcription errors – an intervention within the VIPVIZA study
  21. A survey on measurement and reporting of total testosterone, sex hormone-binding globulin and free testosterone in clinical laboratories in Europe
  22. Quality indicators in laboratory medicine: a 2020–2023 experience in a Chinese province
  23. Impact of delayed centrifugation on the stability of 32 biochemical analytes in blood samples collected in serum gel tubes and stored at room temperature
  24. Concordance between the updated Elecsys cerebrospinal fluid immunoassays and amyloid positron emission tomography for Alzheimer’s disease assessment: findings from the Apollo study
  25. Novel protocol for metabolomics data normalization and biomarker discovery in human tears
  26. Use of the BIOGROUP® French laboratories database to conduct CKD observational studies: a pilot EPI-CKD1 study
  27. Reference Values and Biological Variations
  28. Consensus instability equations for routine coagulation tests
  29. Hematology and Coagulation
  30. Flow-cytometric lymphocyte subsets enumeration: comparison of single/dual-platform method in clinical laboratory with dual-platform extended PanLeucogating method in reference laboratory
  31. Cardiovascular Diseases
  32. Novel Mindray high sensitivity cardiac troponin I assay for single sample and 0/2-hour rule out of myocardial infarction: MERITnI study
  33. Infectious Diseases
  34. Cell population data for early detection of sepsis in patients with suspected infection in the emergency department
  35. Letters to the Editor
  36. Lab Error Finder: A call for collaboration
  37. Cascading referencing of terms and definitions
  38. Strengthening international cooperation and confidence in the field of laboratory medicine by ISO standardization
  39. Determining the minimum blood volume required for laboratory testing in newborns
  40. Performance evaluation of large language models with chain-of-thought reasoning ability in clinical laboratory case interpretation
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  42. Dr. Morley Donald Hollenberg. An extraordinary scientist, teacher and mentor
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