LCMS/MS法测定24小时尿皮质醇参考范围的大数据测定及验证。

IF 5.3 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM
Gregory A Kline, Erik S Venos, David Campbell, Alexander A Leung, Dennis Orton
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引用次数: 0

摘要

目的:24小时尿游离皮质醇(UFC)是库欣综合征(CS)的一线检测方法。一种新的UFC质谱分析方法需要一个适用于筛查人群的有效的、相关的参考范围。设计:在加拿大政府卫生系统和三级内分泌诊所进行回顾性和前瞻性队列研究。参与者为具有CS潜在特征的患者。方法:采用refineR参考区间算法,从4830例非CS患者的UFC结果中得出95%的中间参考区间,与120例排除CS的前瞻性患者进行比较。结果:UFC和24小时尿量相关(r=0.28)。结论:我们使用了大量人群数据,其中CS的患病率可能非常罕见,加上仔细表型的样本,其中CS被考虑但被排除在外,通过质谱法推导出24小时UFC的有效参考区间,反映了现实世界中使用该测试的人群。鉴于总体分布的上尾高度倾斜,可能需要多模态诊断确认CS的高检测特异性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Big data determination and validation of reference range for 24-h urine cortisol by liquid chromatography-mass spectrometry.

Objective: Twenty-four-hour urine-free cortisol (UFC) is a first-line test for Cushing syndrome (CS). A new mass spectrometry assay for UFC requires a validated, relevant reference range appropriate to a screening population.

Design: Combined retrospective and prospective cohort study in a government health system and tertiary endocrinology clinic, Canada. Participants were patients with potential features of CS.

Methods: The refineR reference interval algorithm was used to derive a middle 95%ile reference interval from 4830 UFC results in non-CS patients, compared with 120 prospective patients where evaluation excluded CS.

Results: Urine-free cortisol and 24-h urine volume were correlated (r = 0.28, P < .0001). There was no significant difference between the volume-corrected UFC distributions in the prospective vs retrospective populations (P = .09). Urine-free cortisol distribution was highly skewed (P < .0001) and showed strong sex interaction. The refineR-generated adult male UFC upper reference limit was 238 nmol/day (86.3 μg/day) and for females was 147 nmol/day (53.3 μg/day); urine volume-corrected, the upper limits were 89 nmol/L (32.3 μg/L) and 91 nmol/L (32.9 μg/L), respectively. Applied to both populations, between 3% and 8% of all results would be flagged high; most are expected to represent nonneoplastic (pseudo)Cushing's.

Conclusions: We used mass population data, where the prevalence of CS was likely very rare, plus a carefully phenotyped sample where CS was considered but excluded, to derive a validated reference interval for 24-h UFC by mass spectrometry in populations that reflect real-world use of the test. Given the highly skewed upper tail of the population distribution, it is probable that high test specificity for CS will require multimodality diagnostic confirmation.

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来源期刊
European Journal of Endocrinology
European Journal of Endocrinology 医学-内分泌学与代谢
CiteScore
9.80
自引率
3.40%
发文量
354
审稿时长
1 months
期刊介绍: European Journal of Endocrinology is the official journal of the European Society of Endocrinology. Its predecessor journal is Acta Endocrinologica. The journal publishes high-quality original clinical and translational research papers and reviews in paediatric and adult endocrinology, as well as clinical practice guidelines, position statements and debates. Case reports will only be considered if they represent exceptional insights or advances in clinical endocrinology. Topics covered include, but are not limited to, Adrenal and Steroid, Bone and Mineral Metabolism, Hormones and Cancer, Pituitary and Hypothalamus, Thyroid and Reproduction. In the field of Diabetes, Obesity and Metabolism we welcome manuscripts addressing endocrine mechanisms of disease and its complications, management of obesity/diabetes in the context of other endocrine conditions, or aspects of complex disease management. Reports may encompass natural history studies, mechanistic studies, or clinical trials. Equal consideration is given to all manuscripts in English from any country.
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