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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

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posted on 2023-08-31, 10:25 authored by Channa N Jayasena, Nipun Lakshitha de Silva, Michael O'ReillyMichael 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

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. 

Funding

Society for Endocrinology

MRC

NIHR

NIHR Biomedical Research Centre Funding Scheme and the NIHR/Imperial Clinical Research Facility

NIHR post-doctoral fellowship

History

Comments

The original article is available at https://journals.sagepub.com/

Published Citation

Jayasena CN. et al. 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. Ann Clin Biochem. 2023;60(4):223-227.

Publication Date

30 June 2023

PubMed ID

37391940

Department/Unit

  • Medicine

Publisher

Sage

Version

  • Published Version (Version of Record)