糖尿病相关检测试剂注册技术要点解析

Analysis of key technical points of diagnostic reagents for diabetes

检测血液中葡萄糖和糖化血红蛋白的浓度,可辅助用于糖尿病的诊断和治疗监测。随着世界范围内糖尿病的高发,该类试剂一直是注册申报的热点。本文参考国内外相关标准和技术性文件,结合血糖和糖化血红蛋白检测试剂的特性,对注册申报过程中的技术要点进行解析,以期为企业研发和注册工作人员提供一些思路和帮助。

Detecting the concentration of glucose and hemoglobin A1cin blood can be used in the diagnosis and treatment monitoring of diabetes.With the high incidence of diabetes worldwide,these diagnostic reagents for diabetes have gradually become the hot spot of registration.In view of the characteristics of these reagents,this review analyzes the main technical issues referring to internal and overseas related technical documentation,to providing ideas and help for product development and registration.