Department of Clinical Biochemistry, Black Country Pathology Services, Walsall Manor Hospital, Walsall, UK.
The School of Medicine and Clinical Practice & Department of Biomedical Science and Physiology, The University of Wolverhampton, Wolverhampton, UK.
Int J Clin Pract. 2020 Nov;74(11):e13607. doi: 10.1111/ijcp.13607. Epub 2020 Aug 2.
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.
近年来，已经发布了许多关于性腺功能减退症（HG）的诊断和管理的指导文件。实验室实践在支持具有准确和精确的血清总睾酮（TT）方法和标准化的分析前和分析后协议的指南方面起着重要作用。我们的研究调查了实验室实践目前是否支持 HG 的管理指南。
对英国/爱尔兰的高级实验室生物化学师进行了基于互联网的问卷调查（2018 年 4 月至 5 月）。问题反映了采样、实验室实践、参考范围和结果报告。分析结果时结合了从英国国家外部质量保证服务（UK NEQAS）获得的关于睾酮测定性能的数据。
对 96 份实验室调查的分析得出以下结果：74 家实验室表示已向用户传达了最佳采样时间；81 家实验室使用免疫测定法；76 家实验室包括成年男性的参考范围（31 家有与年龄相关的双/多个间隔）。常见免疫测定法中的下限/上限差异很大；大多数参考范围来自制造商（50.0％）或历史数据（18.8％）。64 家实验室使用基于 TT 水平的行动限，但 63 家实验室未按照指南报告边界范围。58 家实验室有基于 TT 的级联测试方案，其中 50 家实验室提供估计的游离睾酮；67 家实验室提供了解释性评论，但未参考管理指南。UK NEQAS 的数据表明，睾酮测定性能存在很大差异。
我们的调查突出了可能导致 HG（和其他需要测量 TT 的疾病）管理不当的不一致之处。这项调查和 UK NEQAS 的结果都强调需要采取行动，以考虑标准化睾酮测定和协调实验室实践。
