4种SARS-CoV-2核酸检测试剂一致性评价

Consistency evaluation of 4 nucleic acid detection kits for severe acute respiratory syndrome coronavirus 2

目的评估4种严重急性呼吸综合征冠状病毒2(SARS-CoV-2)核酸检测试剂盒在新型冠状病毒肺炎(COVID-19)诊断中的一致性。方法收集2020年2月18—24日武汉亚心总医院204例COVID-19住院患者临床资料,利用检测剩余标本,对4家通过应急注册审批的SARS-CoV-2核酸检测试剂盒进行一致性评价。在临床诊断为COVID-19的基础上,以任一试剂检出阳性为参考,分别比较4种试剂盒检测SARS-CoV-2ORF1ab基因、N基因的敏感性和特异性。采用Kappa一致性分析和χ^2检验对检测结果的一致性进行统计学分析。结果 4种试剂对SARS-CoV-2的整体检出率分别为72.4%、78.0%、59.3%和72.4%,差异有统计学意义(P=0.011)。A、B、C、D试剂对SARS-CoV-2 ORF1ab基因的检出率分别是47.7%、31.8%、68.2%和83.2%(P<0.000 1);A、B、C试剂对SARS-CoV-2 N基因的检出率分别是79.0%、90.5%和16.2%(P<0.000 1)。结论SARS-CoV-2核酸检测试剂盒存在一定比例的假阴性结果,不同品牌SARS-CoV-2核酸检测试剂检测性能差异有统计学意义,多试剂联合检测有利于提高病毒检出率。

Objective To evaluate the consistency of 4 severe acute respiratory syndrome coronavirus 2(SARSCoV-2) nucleic acid detection kits in the diagnosis of corona virus disease 2019(COVID-19). Methods A total of 204 inpatients diagnosed with COVID-19 in Wuhan Asia General Hospital from February 18,2020 to February 24,2020 were enrolled. The residual samples were used to evaluate the consistency of 4 SARS-CoV-2 nucleic acid detection kits approved for emergency registration. Based on the clinical diagnosis of COVID-19,the positive detection of any of the 4 kits was used as a reference. The sensitivities and specificities of the 4 kits for the detections of ORF1 ab gene and N gene were compared. The consistency was analyzed statistically by Kappa consistency analysis and Chi-square test. Results The overall detection rates of the 4 kits were 72.4%,78.0%,59.3% and 72.4%,respectively(P=0.011). The detection rates of A,B,C and D kits for ORF1 ab gene were 47.7%,31.8%,68.2% and 83.2%,respectively(P<0.000 1). The detection rates of A,B and C kits for N gene were 79.0%,90.5% and 16.2%,respectively(P<0.000 1). Conclusions There is a certain proportion of false negativity in SARSCoV-2 nucleic acid detection kits,and there is statistical significance in the performance of nucleic acid detection kits with different brands. The detection rate may be improved using nucleic acid detection kits with different brands combinedly.