An Audit of the Measurement and Reporting of Male Testosterone Levels in UK Clinical Biochemistry Laboratories.

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Livingston, Mark and Downie, Paul and Hackett, Geoff and Marrington, Rachel and Heald, Adrian and Ramachandran, Sudarshan (2020) An Audit of the Measurement and Reporting of Male Testosterone Levels in UK Clinical Biochemistry Laboratories. International journal of clinical practice. e13607. ISSN 1742-1241. This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs

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Official URL: https://onlinelibrary.wiley.com/journal/17421241

Abstract

INTRODUCTION

A number of guidance documents have been published in recent years for diagnosis and management of hypogonadism (HG). Laboratory practice has a major role in supporting guidelines with accurate and precise total serum testosterone (TT) methods and standardised pre- and post-analytical protocols. Our study investigated whether laboratory practice currently supports the management guidelines for HG.

METHODS

An internet-based questionnaire-survey of senior laboratory biochemists (UK/Republic of Ireland) was conducted (April-May 2018). Questions reflected sampling, laboratory practice, reference ranges and reporting of results. The results were analysed in conjunction with data obtained from the UK National External Quality Assurance Service (UK NEQAS) on assay performance.

RESULTS

Analyses of 96 laboratory surveys returned the following: 74 laboratories stated that optimal sampling time was communicated to users; 81 laboratories used immunoassays; 76 laboratories included reference ranges for adult men (31 had dual/multiple age-related intervals). Wide variability in lower/upper limits was evident in the common immunoassays; the majority of reference ranges were from manufacturers (50.0%) or historical (18.8%). Action limits based on TT levels were used by 64 laboratories, but 63 did not report a borderline range as suggested by guidelines. Protocols for cascading tests based on TT were evident in 58 laboratories, with 50 laboratories offering estimated free testosterone; Interpretative comments were provided by 67 laboratories, but no references were made to management guidelines. Data from UK NEQAS demonstrated considerable variation in testosterone assay performance.

CONCLUSIONS

Our survey has highlighted inconsistencies that could lead to HG (and other conditions requiring TT measurement) not being managed appropriately. The results from this survey and from UK NEQAS reinforce the requirement for action to be considered regarding the standardisation of testosterone assays and harmonisation of laboratory practice.

Item Type: Article
Additional Information: This article is available to all UHB staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their UHB Athens login IDs
Subjects: QU Biochemistry
WK Endocrine system. Endocrinology
Divisions: Ambulatory Care > Endocrinology
Related URLs:
Depositing User: Jamie Edgar
Date Deposited: 24 Jul 2020 14:37
Last Modified: 24 Jul 2020 14:37
URI: http://www.repository.uhblibrary.co.uk/id/eprint/3311

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