国产实验室新型冠状病毒核酸快速检测试剂上市后多中心临床评价  

Multicenter post-marketing clinical evaluation on the clinical performance of the five domestic fast nucleic acid detection reagents for 2019-nCoV

作　　者：冯永辉 余斐[2] 鲁艳军[3] 杨梦婕[4] 张靖[4] 韩晓旭 尚红 Feng Yonghui;Yu Fei;Lu Yanjun;Yang Mengjie;Zhang Jing;Han Xiaoxu;Shang Hong(National Clinical Research Center forLaboratory Medicine,Shenyang 110001,China;"Department of Laboratory Medicine,the First Affiliated Hospital,Zhejiang University school of Medicine,Hangzhou 310003,China;Department of Clinical Laboratory,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China;National Institute of Viral Disease Control and Prevention,Chinese Center for Disease Control and Prevention,Beijing 102206,China)

机构地区：[1]国家医学检验临床医学研究中心,沈阳110001 [2]浙江大学医学院附属第一医院检验科,杭州310003 [3]华中科技大学同济医学院附属同济医院检验科,武汉430030 [4]中国疾病预防控制中心病毒病预防控制所,北京102206

出　　处：《中华检验医学杂志》2022年第10期1045-1048,共4页Chinese Journal of Laboratory Medicine

基　　金：国家重点研发计划(2020YFC0848000)。

摘　　要：目的对我国已批准上市的5种新型冠状病毒(2019-nCoV)核酸快速检测试剂进行多中心临床评价。方法2020年11月在浙江大学医学院附属第一医院、华中科技大学同济医学院附属同济医院和中国疾病预防控制中心病毒病预防控制所3家机构选取共计57份确诊2019-nCoV感染者及15份非感染者的咽拭子样本,对获批上市的5种2019-nCoV核酸快速检测试剂进行检测,分析阳性符合率、阴性符合率、总符合率,并分析阳性强度与阳性符合率的关系,检测时间和复检率情况。结果5种试剂盒阳性符合率为92.59%(50/54)、83.64%(46/55)、98.25%(56/57)、94.44%(51/54)和98.18%(54/55);阴性符合率为93.33%(14/15)、93.33%(14/15)、86.67%(13/15)、100%(14/14)和93.33%(14/15);总符合率为92.75%(64/69)、85.71%(60/70)、95.83%(69/72)、94.20%(65/69)和97.14%(68/70)。5种试剂盒对强阳性和中阳性标本的检出率均为100%(90/90、84/84),对循环阈值33以上的弱阳性样本检出率为82.18%(83/101),2种试剂盒的复检率高于10%,分别为15.28%(11/72)和12.50%(9/72)。5种试剂盒从提取到扩增检测所需平均总时长在32.33~65.33 min。结论5种2019-nCoV核酸快速检测试剂盒性能均较好,可以作为常规核酸检测的补充。Objective:This multicenter clinical evaluation analyzed the clinical performance of five fast nucleic acid detection systems for 2019-nCoV.Methods:Clinical performance of the five fast nucleic acid detection reagents approved in China was evaluated in the present study. Fifty-seven throat swabs samples from COVID-19 patients and fifteen throat swabs samples from healthy people were collected from the First Affiliated Hospital of Zhejiang University school of Medicine, Tongji Hospital of Tongji Medical College of HUST, and National Institute of Viral Disease Control and Prevention of CDC to evaluate the positive coincidence rate, negative coincidence rate, total coincidence rate, the detection time and retest rate as well as the relation between positive intensity and positive coincidence rate of the five fast nucleic acid detection systems in November 2020.Results:The positive coincidence rates of the five kits were 92.59% (50/54), 83.64% (46/55), 98.25% (56/57), 94.44% (51/54) and 98.18% (54/55);and the negative coincidence rates were 93.33% (14/15), 93.33% (14/15), 86.67% (13/15), 100% (14/14) and 93.33% (14/15);and the total coincidence rates were 92.75% (64/69), 85.71% (60/70), 95.83% (69/72), 94.20% (65/69) and 97.14% (68/70), respectively. The positive coincidence rate of the five kits reached 100% for the strong-positive (90/90) and medium-positive samples (84/84), but only 82.18% (83/101) for weak-positive samples (cycle threshold value>33), and the retest rate of two kits were 15.28% (11/72) and 12.50% (9/72), which were both higher than 10%. Total time from sample extraction to amplification was between 32.33-65.33 minutes for these five kits.Conclusion:The five fast nucleic acid detection reagents have good performance and can be used as a supplement to routine nucleic acid detection reagents.

关 键 词：新型冠状病毒 实时荧光定量PCR 核酸快速检测技术 性能评价 

分 类 号：R440[医药卫生—诊断学]