摘要
对包含具有可比性的样本类型的定量检测试剂在注册申报中,需要样本适用性评价,方式可以参考实验室样本检测评价,主要包括可比性验证、测量程序内比对和干扰试验。本文结合体外诊断试剂注册申报要求及注册审查指导原则,系统阐述了具有可比性的样本类型的内容及国内外技术文件的评价方式,旨在为定量检测试剂的性能评价和注册申报提供参考。
For quantitative tests with comparable sample types,an evaluation of sample application is necessary during registration.The method can be based on laboratory sample testing evaluation,which includes comparability verification,intra-measurement procedure comparison,and interference testing.This paper,systematically explains the concept of comparable sample types and evaluation methods found in domestic and foreign technical documents in accordance with the requirements for the registration and application of in vitro diagnostic reagents and registration review guidelines.The goal is to offer guidance for the performance evaluation and registration declaration of quantitative detection reagents.
作者
吴昊楠
熊宇婷
WU Haonan;XIONG Yuting(Yangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA,Shanghai,China,201210)
出处
《分子诊断与治疗杂志》
2026年第1期222-224,共3页
Journal of Molecular Diagnostics and Therapy
关键词
样本类型
适用性
可比性
测量程序比对
干扰试验
Sample Type
Suitability
Comparability
Measurement Procedure Comparison
Interference Testing
