A-149 Reduction of Unnecessary Free and Bioavailable Testosterone Orders Using a Reflex Strategy

IF 8.3 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Clinical chemistry Pub Date : 2026-10-04 DOI:10.1093/clinchem/hvag086.120

Christopher Koch, Dennis Orton, Victoria Higgins, Michael Reid, Ashley Newbigging, Evan Hagen, Joshua Raizman

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引用次数: 0

Abstract

Background Evaluation of testosterone concentration is central to the diagnosis of male hypogonadism, with total testosterone (TT) recommended as the first-line screen in most clinical guidelines. Measurement or calculation of free (FT) or bioavailable testosterone (BAT) are only recommended in select circumstances, particularly when abnormalities in sex hormone binding globulin (SHBG) concentration or function are suspected. Nonetheless, FT and BAT are frequently ordered alongside TT in routine practice, raising concerns regarding overutilization. In this study we optimized calculated FT (cFT) and calculated BAT (cBAT) reference intervals, evaluated cFT/cBAT utilization and clinical utility relative to TT, and defined TT thresholds at which reflexing to cFT/cBAT is most likely to provide further value. Methods TT/SHBG (immunoassay, Roche) and albumin (various platforms) data from adult male patients was extracted from the laboratory information system (N=81,023). Reference intervals for cFT/cBAT were established using RefineR after excluding duplicates, inpatients, non-morning collections, and patients with abnormal diabetes, sex hormone, or prostate markers (N=22,101). Logistic regression was used to model the probability of low cFT/cBAT as a function of continuous TT after excluding duplicates (N=45,977). Results cFT RIs decreased with age with optimal partitioning in 10-year bins. Logistic regression showed a strong inverse association between TT and odds of low cFT (slope = -1.14, odds ratio = 0.32 per 1 nmol/L (∼29 ng/dL) TT increase, p<2×10?¹6), where 1 nmol/L (∼29 ng/dL) decrease in TT approximately tripled the odds of low FT. TT results of =2.5 nmol/L (72 ng/dL) predicted low cFT with 95% probability, while >7.6 nmol/L (219 ng/dL) predicted normal FT, defining a reflex range of 2.5-7.5 nmol/L (∼72-218 ng/dL). In unfiltered data, 10.9% of FT results fell within this interval. cBAT showed similar patterns. Conclusion TT by immunoassay strongly predicted cFT and cBAT, indicating limited incremental diagnostic value from routine FT/BAT testing. By quantifying the probability of low cFT or cBAT when TT exceeds the lower reference limit, reflex algorithms can be derived to substantially reduce unnecessary testing.

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a -149使用反射策略减少不必要的游离和生物可利用睾酮订单

睾酮浓度的评估是诊断男性性腺功能减退的核心，在大多数临床指南中，总睾酮（TT）被推荐为一线筛查。仅在特定情况下才推荐测量或计算游离睾酮（FT）或生物可利用睾酮（BAT），特别是当怀疑性激素结合球蛋白（SHBG）浓度或功能异常时。尽管如此，在日常操作中，FT和BAT经常与TT一起被订购，这引发了人们对过度使用的担忧。在本研究中，我们优化了计算FT （cFT）和计算BAT （cBAT）参考区间，评估了cFT/cBAT的利用率和相对于TT的临床效用，并定义了TT阈值，在该阈值上，cFT/cBAT最可能提供进一步的价值。方法从实验室信息系统（N=81,023）中提取成年男性患者TT/SHBG（免疫测定，罗氏）和白蛋白（各平台）数据。在排除重复、住院患者、非早晨采集、糖尿病、性激素或前列腺标志物异常患者后，使用RefineR建立cFT/cBAT的参考区间（N= 22101）。排除重复后，采用Logistic回归对低cFT/cBAT的概率作为连续TT的函数进行建模（N=45,977）。结果cFT RIs随年龄的增长而下降，以10年为单位划分最佳。Logistic回归显示TT与低cFT发生率之间存在很强的负相关(斜率= -1.14，比值比= 0.32 / 1 nmol/L (~ 29 ng/dL) TT增加，p<2×10？¹6)，其中1 nmol/L （~ 29 ng/dL）的TT降低约使低FT的几率增加了两倍。TT结果=2.5 nmol/L （72 ng/dL）预测低cFT的概率为95%，而&；gt;7.6 nmol/L （219 ng/dL）预测正常FT，定义了2.5-7.5 nmol/L （~ 72-218 ng/dL）的反射范围。在未过滤的数据中，10.9%的FT结果落在这个区间内。cBAT显示了类似的模式。结论TT免疫分析法对cFT和cBAT有较强的预测作用，提示常规FT/BAT检测的增加诊断价值有限。通过量化TT超过下参考限值时低cFT或cBAT的概率，可以推导出反射算法，从而大大减少不必要的测试。

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来源期刊

Clinical chemistry 医学-医学实验技术

CiteScore

11.30

自引率

4.30%

发文量

212

审稿时长

1.7 months

期刊介绍： Clinical Chemistry is a peer-reviewed scientific journal that is the premier publication for the science and practice of clinical laboratory medicine. It was established in 1955 and is associated with the Association for Diagnostics & Laboratory Medicine (ADLM). The journal focuses on laboratory diagnosis and management of patients, and has expanded to include other clinical laboratory disciplines such as genomics, hematology, microbiology, and toxicology. It also publishes articles relevant to clinical specialties including cardiology, endocrinology, gastroenterology, genetics, immunology, infectious diseases, maternal-fetal medicine, neurology, nutrition, oncology, and pediatrics. In addition to original research, editorials, and reviews, Clinical Chemistry features recurring sections such as clinical case studies, perspectives, podcasts, and Q&A articles. It has the highest impact factor among journals of clinical chemistry, laboratory medicine, pathology, analytical chemistry, transfusion medicine, and clinical microbiology. The journal is indexed in databases such as MEDLINE and Web of Science.