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SARSCoV-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(试剂盒A与C比较)、0.510(试剂盒A与D比较)、0.669(试剂盒B与C比较)、0.633(试剂盒B与D比较)、0.565(试剂盒C与D比较)(P<0.01)。试剂盒A、B、C和D检测结果的阳性率分别为39.94%、30.50%、31.45%和18.55%,除了试剂盒B和C之间的阳性率差异无统计学意义(P>0.05)外,其他试剂盒间检测结果阳性率差异均有统计学意义(P<0.05)。试剂盒A、B、C、D的敏感性和特异性分别为98.2%和90.4%、87.1%和99.0%、82.6%和95.2%、54.1%和100.0%,试剂盒D与其他3种试剂盒的总符合率的差异均有统计学意义(P<0.05)。结论试剂盒A和试剂盒B结果的一致性最高,其中试剂盒A的敏感性更优,准确性较好。试剂盒D敏感性较差,对新型冠状病毒肺炎(COVID-19)的漏诊风险较大。 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.
出处 《检验医学》 CAS 2021年第4期396-399,共4页 Laboratory Medicine
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 Severe acute respiratory syndrome coronavirus 2 Nucleic acid detection Pharyngeal swab Comparison Kit
