摘要
睾酮是机体内重要的内分泌激素,睾酮血清水平检测是临床生化检测的重要项目,该文旨在对睾酮测定试剂在注册申报资料中的问题进行分析并提出建议。通过介绍该类试剂的注册情况,分析目前该类试剂在注册申报和临床使用中的问题,并对相应申报资料的特殊性要求进行探讨。
Testosterone is an important endocrine hormone in the human body,and the measurement of serum testosterone levels is a key component of clinical biochemical testing.This paper aims to analyze common issues encountered in the registration dossier of testosterone in vitro diagnostic devices and propose corresponding recommendations.Based on an overview of reagent registration requirements,we examine problems that arise in product registration dossiers as well as challenges observed in clinical application and further analyze the special regulatory and technical requirements for this category of diagnostic products.
作者
张苏琳
蔡瑶
孙骏
ZHANG Sulin;CAI Yao;SUN Jun(Center for Evaluation of Jiangsu Medical Products Administration,Nanjing,China,210002)
出处
《分子诊断与治疗杂志》
2026年第2期442-444,共3页
Journal of Molecular Diagnostics and Therapy
关键词
体外诊断试剂
睾酮
In vitro diagnostic reagents
Testosterone
