An audit of the measurement and reporting of male testosterone levels in UK clinical biochemistry laboratories.
Journal
International journal of clinical practice
ISSN: 1742-1241
Titre abrégé: Int J Clin Pract
Pays: India
ID NLM: 9712381
Informations de publication
Date de publication:
Nov 2020
Nov 2020
Historique:
received:
06
03
2020
accepted:
06
07
2020
pubmed:
11
7
2020
medline:
28
4
2021
entrez:
11
7
2020
Statut:
ppublish
Résumé
A number of guidance documents have been published in recent years for the diagnosis and management of hypogonadism (HG). Laboratory practice has a major role in supporting guidelines with accurate and precise serum total testosterone (TT) methods and standardised pre- and post-analytical protocols. Our study investigated whether laboratory practice currently supports the management guidelines for HG. 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 testosterone assay performance. Analyses of 96 laboratory surveys returned the following: 74 laboratories stated that the 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 the 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 the management guidelines. Data from UK NEQAS demonstrated considerable variation in testosterone assay performance. Our survey has highlighted inconsistencies that could lead to HG (and other conditions requiring measurement of TT) 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.
Substances chimiques
Testosterone
3XMK78S47O
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e13607Informations de copyright
© 2020 The Authors. International Journal of Clinical Practice published by John Wiley & Sons Ltd.
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