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
Jayasena, Channa N de Silva, Nipun Lakshitha O'Reilly, Michael W MacKenzie, Finlay Marrington, Rachel Jones, Hugh Livingston, Mark Downie, Paul Hackett, Geoff Ramachandran, Sud
Jayasena, Channa N
de Silva, Nipun Lakshitha
O'Reilly, Michael W
MacKenzie, Finlay
Marrington, Rachel
Jones, Hugh
Livingston, Mark
Downie, Paul
Hackett, Geoff
Ramachandran, Sud
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Affiliation
Imperial College; University of Medicine and Health Sciences; University Hospitals Birmingham NHS Foundation Trust; University Hospitals NHS Foundation Trust; Royal Hallamshire Hospital; Walsall Healthcare NHS Trust;
The University of Wolverhampton; Bristol Royal Infirmary; Spire Hospital; University Hospitals Birmingham NHS Foundation Trust; University of Oxford;
Princess of Wales Hospital; Royal Victoria Infirmary; Great Western Hospital NHS Foundation Trust; Bedfordshire Hospitals NHS Foundation Trust; University of Manchester; Newcastle-upon-Tyne Hospitals NHS Foundation Trust & University of Newcastle-upon-Tyne
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Publication date
2023-06-30
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Collections
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Abstract
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.
Citation
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. 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 Jul;60(4):223-227.
Type
Article