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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*

Lookup NU author(s): Dr Richard Quinton

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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).


Abstract

© The Author(s) 2023.Background: Inter-assay variation between different immunoassays and different mass spectrometry methods hampers the biochemical confirmation of male hypogonadism. Furthermore, some laboratories utilis eassay 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.


Publication metadata

Author(s): Jayasena CN, de Silva NL, O'Reilly MW, MacKenzie F, Marrington R, Jones H, Livingston M, Downie P, Hackett G, Ramachandran S, Tomlinson J, David J, Boot C, Patel M, Tarling J, Wu F, Quinton R

Publication type: Article

Publication status: Published

Journal: Annals of Clinical Biochemistry

Year: 2023

Volume: 60

Issue: 4

Pages: 223-227

Print publication date: 01/07/2023

Online publication date: 30/06/2023

Acceptance date: 12/05/2023

Date deposited: 01/08/2023

ISSN (print): 0004-5632

ISSN (electronic): 1758-1001

Publisher: SAGE Publications Ltd

URL: https://doi.org/10.1177/00045632231179022

DOI: 10.1177/00045632231179022

PubMed id: 37391940


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Funding

Funder referenceFunder name
MRC
NIHR
NIHR Biomedical Research Centre Funding Scheme
NIHR/Imperial Clinical Research Facility
Society for Endocrinology

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