基于注册审评的流式细胞仪配套检测试剂的临床评价概述

Registration Review of Clinical Evaluation on Flow Cytometry in Vitro Diagnostic Reagents Detection Reagents

从体外诊断试剂注册技术审评角度出发,以流式细胞仪配套检测试剂为例,从法规依据、临床评价的分类及要求、临床评价的主要关注点等方面进行了阐述,尤其对临床评价的样本量要求、评价指标、对比试剂的选择、临床试验的监查与质控等方面进行了重点介绍,旨在为注册申请人对该类产品进行临床评价提供技术指导,同时为技术审评部门对临床评价资料的技术审评提供参考。

This paper discusses the evaluation approach for clinical evaluation of in vitro diagnostic reagents from the perspective of technical evaluation of in vitro diagnostic reagent registration,taking flow cytometry matching detection reagents as an example.This article elaborates on the regulatory basis,classification and requirements of clinical evaluation,and main focus points of clinical evaluation,with a focus on sample size requirements,evaluation indicators,selection of comparative reagents,and monitoring and quality control of clinical trials.The aim is to provide technical guidance for registration applicants to conduct clinical evaluation of such products,at the same time,it provides reference for the technical review of clinical evaluation data by the technical review department.