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Standardising the biochemical confirmation of adult male hypogonadism: A joint position statement by the Society for Endocrinology and Association of Clinical Biochemistry and Laboratory Medicine

Year: 2023
Type: article
Abstract: BACKGROUND: Inter-assay variation between different immunoassays and different mass spectrometry methods hampers the biochemical confirmation of male hypogonadism. Furthermore, some laboratories utilise assay manufacturer reference ranges that do not necessarily mirror assay performance characteristics, with the lower limit of normality ranging from 4.9 nmol/L to 11 nmol/L. The quality of the normative data underlying commercial immunoassay reference ranges is uncertain. DESIGN: A working group reviewed published evidence and agreed upon standardised reporting guidance to augment total testosterone reports. RESULTS: Evidence-based guidance on appropriate blood sampling, clinical action limits, and other major factors likely to affect the interpretation of results are provided. CONCLUSIONS: This article aims to improve the quality of the interpretation of testosterone results by non-specialist clinicians. It also discusses approaches for assay harmonisation which have been successful in some but not all healthcare systems.
DOI: 10.1111/cen.14929
Authors: Channa N. Jayasena, Nipun L. de Silva, Michael W. O'Reilly, Finlay MacKenzie, Rachel Marrington, Hugh Jones, Mark Livingston, Paul Downie, Geoff Hackett, Sud Ramachandran, Jeremy Tomlinson, Janine David, Christopher Boot, Mayur Patel, Julie Tarling, Fredrick Wu, Richard Quinton
Institutions: Imperial College London, Royal College of Surgeons in Ireland, University Hospitals Birmingham NHS Foundation Trust, Royal Hallamshire Hospital, University of Sheffield, University of Wolverhampton, Walsall Manor Hospital, Bristol Royal Infirmary, Oxford Centre for Diabetes, Endocrinology and Metabolism, Princess of Wales Hospital, Royal Victoria Infirmary, Great Western Hospital, Great Western Hospitals NHS Foundation Trust, Bedford Hospital NHS Trust, University of Manchester, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne Hospital, Newcastle University
Language: English
Field: Medicine
Open Access status: hybrid
Estimated APC paid: $4,330
OpenAlex ID: W4382792632
FWCI: 1.325
Cites: 26
Cited by: 8
Related to: 10