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
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.
Society for Endocrinology
NIHR Biomedical Research Centre Funding Scheme
NIHR/Imperial Clinical Research Facility
NIHR postdoctoral fellowship
CommentsThe original article is available at https://onlinelibrary.wiley.com/
Published CitationJayasena 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. Clin Endocrinol (Oxf). 2023
Publication Date1 July 2023
- Published Version (Version of Record)