Analysis of key technical points of diagnostic reagents for diabetes / 中华检验医学杂志

ABSTRACT

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.