Gonzalez-Carranza Hector Rodrigo, Morgentaler Abraham, Reyes-Vallejo Luis Antonio
Department of Urology, Angeles Metropolitano Hospital, Mexico City, Mexico.
Department of Urology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Transl Androl Urol. 2025 Jun 30;14(6):1759-1764. doi: 10.21037/tau-2025-162. Epub 2025 Jun 26.
The diagnosis of testosterone deficiency (hypogonadism) requires documentation of low testosterone concentration. Despite the thresholds for low testosterone established by various guidelines, non-expert physicians rely on reference ranges provided by laboratories. The objective of this study was to determine the consistency of laboratory-established reference ranges for total testosterone (TT) among Mexico City clinical laboratories.
Information was requested from 202 laboratories in Mexico City in August 2024. The items of interest included the TT reference ranges, equipment, assays, and costs.
The responses were obtained from 134 laboratories. There were 27 different sets of reference ranges used in this study. The high TT threshold ranged from 400 to 1,719 ng/dL (variability: 487%), whereas the lower limit ranged from 84 to 470 ng/dL (variability: 426%). Five measurement methods were described, and the most frequently used was chemiluminescence 69 (51.11%), followed by electrochemiluminescence 25 (18.65%). The cost ranged from $9-160 USD, with a mean of $35 USD.
The extreme variability in laboratory-established TT reference ranges represents a major challenge for the appropriate diagnosis and management of men with symptomatic testosterone deficiency. Although these results were obtained in Mexico City, there is good reason to believe that this problem exists globally.
睾酮缺乏（性腺功能减退）的诊断需要记录低睾酮浓度。尽管各种指南已确定了低睾酮的阈值，但非专业医生依赖实验室提供的参考范围。本研究的目的是确定墨西哥城各临床实验室之间总睾酮（TT）的实验室参考范围的一致性。
2024年8月，向墨西哥城的202家实验室索取信息。感兴趣的项目包括TT参考范围、设备、检测方法和成本。
收到了134家实验室的回复。本研究中使用了27套不同的参考范围。TT的高阈值范围为400至1719 ng/dL（变异性：487%），而低限范围为84至470 ng/dL（变异性：426%）。描述了五种测量方法，最常用的是化学发光法69例（51.11%），其次是电化学发光法25例（18.65%）。成本范围为9至160美元，平均为35美元。
实验室确定的TT参考范围的极端变异性对有症状的睾酮缺乏男性的正确诊断和管理构成了重大挑战。尽管这些结果是在墨西哥城获得的，但有充分理由相信这个问题在全球都存在。
