摘要
目的开展两种待考核试剂(RNA恒温扩增-金探针层析法、双扩增法)和参比试剂[实时荧光定量聚合酶链式反应(quantitative real-time-polymerase chain reaction,qPCR)]的对比实验,评价待考核试剂的应用性能和有效性,能否满足临床检测要求。方法对2020-01-23~03-12日作者医院采集的269份样本,同时采用待考核试剂和参比试剂检测严重急性呼吸综合征冠状病毒2(severe acute respiratory syndrome coronavirus 2,SARS-CoV-2),以临床确诊/排除结果共同评价本次待考核试剂的临床试验结果。结果待考核试剂与参比试剂进行比对,灵敏度98.91%[95%置信区间(confidence interval,CI)(96.79%,100%)],特异性100%[95%CI(97.94%,100%)],总符合率99.63%[95%CI(98.90%,100%)],一致性Kappa值0.99;与临床确诊/排除结果进行比对,咽拭子、痰液、咽拭子+痰液的一致性Kappa值分别为0.90、0.92、0.92;总符合率分别为96.24%、96.39%、96.67%。结论两种SARS-CoV-2核酸检测试剂盒与参比试剂、临床确诊/排除结果比较,SARS-CoV-2检测符合情况良好,符合临床对上市产品的质量要求。
Objective To carry out the comparative experiments of two kinds of reagents to be tested(RNA constant temperature amplification gold probe chromatography,double amplification)and reference reagents[quantitative real-time-polymerase chain reaction(qPCR)],and to evaluate whether the application performance and effectiveness of the reagent to be assessed can meet the requirements of clinical testing.Methods A total of 269 samples were collected in author′s hospital from January 23 to March 12,2020.The severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)was detected by the test reagent and reference reagent,and the clinical test results of this test reagent were evaluated together with the clinical diagnosis/exclusion results.Results The sensitivity was 98.91%[95%confidence interval(CI)(96.79%,100%)],the specificity was 100%[95%CI(97.94%,100%)],the total coincidence rate was 99.63%[95%CI(98.90%,100%)],and the consistency Kappa value was 0.99 between the reagent to be examined and reference reagent.Compared with the clinical diagnosis/exclusion results,the consistency Kappa value of pharyngeal swab,sputum,pharyngeal swab and sputum were 0.90,0.92,0.92,respectively;the total coincidence rates were 96.24%,96.39%,96.67%,respectively.Conclusion Comparison of two SARS-CoV-2 nucleic acid detection kits with reference reagents and clinical diagnosis/exclusion results,the detection of the SARS-CoV-2 is in good condition,and has good clinical performance,which is in line with the quality requirements of clinical products.
作者
彭定辉
陈良君
叶光明
里进
孙慧
王诗婵
陈薇
PENG Dinghui;CHEN Liangjun;YE Guangming;LI Jin;SUN Hui;WANG Shichan;CHEN Wei(Department of Laboratory,Zhongnan Hospital of Wuhan University,Wuhan Hubei 430071,China)
出处
《华南国防医学杂志》
CAS
2020年第7期455-459,共5页
Military Medical Journal of South China
基金
湖北省卫生健康委科研联合项目(WJ2019H070)
关键词
严重急性呼吸综合征冠状病毒2
核酸检测
RNA恒温扩增-金探针层析法
双扩增法
实时荧光定量聚合酶链式反应
Severe acute respiratory syndrome coronavirus 2
Nucleic acid detection
RNA isothermal amplification gold probe chromatography
Double amplification
Quantitative real-time-polymerase chain reaction
