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4种SARS-Cov-2核酸检测试剂盒测定结果分析
引用本文:陈建波,杨勇,李慧源,任婵君,杜娟,李根石,陶然,陈敬贤,张玲,李淼. 4种SARS-Cov-2核酸检测试剂盒测定结果分析[J]. 检验医学, 2021, 0(4): 396-399
作者姓名:陈建波  杨勇  李慧源  任婵君  杜娟  李根石  陶然  陈敬贤  张玲  李淼
作者单位:武汉金域医学检验所;甘肃金域医学检验暨病理诊断所;长沙金域医学检验所;广州金域医学检验中心;国家呼吸系统疾病临床医学研究中心病毒诊断研究中心
摘    要:目的 比对4种严重急性呼吸综合征冠状病毒2(SARS-CoV-2)核酸检测试剂盒测定结果,为实验室选择试剂盒和评估试剂盒性能提供参考.方法 收集318例咽拭子标本,提取核酸后,分别用4种SARS-CoV-2核酸检测试剂盒进行检测.结果 4种试剂盒检测结果比对的Kappa值分别为0.741(试剂盒A与B比较)、0.653...

关 键 词:严重急性呼吸综合征冠状病毒2  核酸检测  咽拭子  比对  试剂盒

Comparison of 4 commercial kits for detecting SARS-CoV-2 nucleic acid
CHEN Jianbo,YANG Yong,LI Huiyuan,REN Chanjun,DU Juan,LI Genshi,TAO Ran,CHEN Jingxian,ZHANG Ling,LI Miao. Comparison of 4 commercial kits for detecting SARS-CoV-2 nucleic acid[J]. Laboratory Medicine, 2021, 0(4): 396-399
Authors:CHEN Jianbo  YANG Yong  LI Huiyuan  REN Chanjun  DU Juan  LI Genshi  TAO Ran  CHEN Jingxian  ZHANG Ling  LI Miao
Affiliation:(Wuhan Kingmed Center for Clinical Laboratory,Wuhan 430100,Hubei,China;Gansu Kingmed Center for Clinical Laboratory,Lanzhou 730070,Gansu,China;Changsha Kingmed Center for Clinical Laboratory,Changsha 410006,Hunan,China;Guangzhou Kingmed Center for Clinical Laboratory,Guangzhou 510005,Guangdong,China;Research Center for Clinical Virology,the National Clinical Research Center for Respiratory Disease,Guangzhou 510005,Guangdong,China)
Abstract:Objective To compare the performance of 4 commercial kits for the detection of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)nucleic acid.Methods Totally,318 pharyngeal swab samples were collected.After nucleic acid extraction,these samples were detected by the 4 commercial kits.Results Kappa values were 0.741(Kit A vs Kit B),0.653(Kit A vs Kit C),0.510(Kit A vs Kit D),0.669(Kit B vs Kit C),0.633(Kit B vs Kit D)and 0.565(Kit C vs Kit D)(P<0.01).The positive rates of Kit A,Kit B,Kit C and Kit D were 39.94%,30.50%,31.45%and 18.55%,respectively.There was statistical significance(P<0.05)except for that between Kit B and Kit C(P>0.05).The sensitivity and specificity were 98.2%and 90.4%for Kit A,87.1%and 99.0%for Kit B,82.6%and 95.2%for Kit C,54.1%and 100.0%for Kit D,respectively,and the accuracy of Kit D was lower than those of the other kits(P<0.05).Conclusions The performance of Kit A is consistent with that of Kit B,and Kit A has good sensitivity and accuracy for the detection of SARS-CoV-2 nucleic acid.Kit D is not appropriate for screening corona virus disease 2019(COVID-19)due to its low sensitivity.
Keywords:Severe acute respiratory syndrome coronavirus 2  Nucleic acid detection  Pharyngeal swab  Comparison  Kit
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