新型冠状病毒检测试剂质量把控要点  

Key Points for Quality Control of 2019 Novel Coronavirus Testing Kits

作　　者：邓敏 DENG Min(Shanghai Institute of Medical Device Testing,Shanghai,201318)

机构地区：[1]上海市医疗器械检验研究院,上海市201318

出　　处：《中国医疗器械杂志》2021年第3期321-325,共5页Chinese Journal of Medical Instrumentation

摘　　要：自新型冠状病毒肺炎COVID-19疫情暴发以来,准确、快速的新型冠状病毒检测技术在疫情防控方面发挥了重要作用。结合实际检测工作、试剂上市情况及对政策法规的理解,针对在检验过程中遇到的实际问题,对2019新型冠状病毒检测试剂质量把控要点方面进行分析和探讨。Since the outbreak of COVID-19,the accurate and rapid clinical diagnosis technology of SARS-CoV-2 has played a crucial role in the prevention and control of epidemic situation.This study aims to analyze and discuss the key points for quality control of 2019 novel coronavirus testing kits,while incorporating the actual testing process,the distribution of testing kits and interpretation of relevant policies and regulations.

关 键 词：2019新型冠状病毒 核酸检测 抗体检测 

分 类 号：TH776[机械工程—仪器科学与技术] F203[机械工程—精密仪器及机械]