病毒核酸检测试剂的性能评估和临床试验

Performance Evaluation and Clinical Test of Viral Nucleic Acid Detection Reagents

随着种类繁多的病毒核酸检测试剂的大规模研发和应用,这些产品的注册和申报流程得到了越来越多的重视,而试剂的性能评估与临床试验一直以来都是申报过程中的重要环节,本文概述了性能评估和临床试验所包括的主要项目,操作规范以及相关的技术要求,为生产企业科学合理地进行核酸类诊断试剂的研制与开发提供指引。

As more and more viral nucleic acid detection reagents were developed and applied,the registration process of these novel reagents is attracting more and more attention. Performance evaluation and clinical test have always been considered as the pivotal steps in the process of reagents registration. In this review,the major point,standard operation and related technical details were summarized so as to guide manufacturers to research and to develop nucleic acid reagents scientifically and rationally.