病毒学实验室资质认定中非标方法的确认研究

摘要

The laboratories of National Institute for Viral Disease Control and Prevention,Chinese Center for Disease Control and Prevention,have developed a series of experimental method.These method have unique advantages over the national standard method and industry standard method.How to make these method become public products through legal procedures to serve disease prevention and control more extensively is an obligatory task for national virological laboratories.This article explores the establishment,verification,validation,and examination of virological non-standard method under laboratory certification and accreditation conditions through empirical research on the " RT-RAA method for detecting EV71/CA16 and other viruses".%中国疾病预防控制中心病毒病预防控制所的各实验室自行研究建立了一系列实验方法,这些方法相比国标方法,行标方法等具有独特的优势,如何让这些方法通过一定法律程序成为公共产品,以便更广泛的为疾病预防控制服务,是作为国家级病毒学实验室义不容辞的任务.本文通过对“RT-RAA法检测EV71/ CA16等病毒”方法的实证研究,探索基于实验室资质认定条件下病毒学非标方法建立、确认、验证、核查等一系列问题.