不同新型冠状病毒核酸检测试剂性能比较分析  

Comparison and analysis oftheperformancein different COVID-19 nucleic acid detection reagents

作　　者：张伟宏[1] 马雯 李富荣[2] 葸静 金哲宇 崔学强[2] 何瑞芬 张俊华[2] 朴文花[2] ZHANG Weihong;MA Wen;LI Furong;XI Jing;JIN Zheyu;CUI Xueqiang;HE Ruifen;ZHANG Junhua;PIAO Wenhua(The Center for Disease Control and Preventionof Yinchuan,Yinchuan 750002,China;The Department of Clinical Medical Examination and Diagnosis Center,Ningxia Hui Autonomous Region People's Hospital,Yinchuan 750002,China;Ningxia Jinyu Medical Laboratory,Yinchuan 750002,China;Department of Orthopedics,The First Affiliated Hospital of Suzhou University,Suzhou 215006,China)

机构地区：[1]宁夏银川市疾病预防控制中心,宁夏银川750002 [2]宁夏回族自治区人民医院临床医学检验诊断中心,宁夏银川750002 [3]宁夏金域医学检验所,宁夏银川750002 [4]苏州大学附属第一医院骨科,江苏苏州215006

出　　处：《宁夏医学杂志》2020年第10期913-916,共4页Ningxia Medical Journal

基　　金：宁夏重点研发计划科技支撑“新型冠状病毒感染的肺炎疫情防控”专项(2020BEG03023)。

摘　　要：目的比较6种新型冠状病毒核酸检测试剂盒的性能,为相关实验室选择核酸检测试剂提供参考依据。方法选择6种国产新型冠状病毒核酸检测试剂盒,比较其基本情况,并用5例阳性患者的咽拭子标本,提取RNA倍比稀释后进行RT-qPCR检测,分析扩增结果,评估各试剂盒的差异。结果使用核酸检测试剂盒检测稀释后的RNA,扩增后可见IC基因、N基因及ORF1ab基因的Ct值及△Rn值有显著差异;在1∶16稀释倍数时F试剂未检测到ORF1ab基因,C试剂在1∶64时无法检出ORF1ab基因和N基因,A、B、D试剂在1∶256稀释倍数时未检测到ORF1ab基因和N基因,E试剂在各个稀释度均可扩增IC、ORF1ab、N及E 4个基因。结论新型冠状病毒核酸检测试剂对低病毒载量核酸的检测能力有较大差异,各实验室选用试剂时需要进行性能验证,根据检测目的和检测对象选择合适的试剂盒。Objective To compare and analyze the detection ability of six domestic SARS-CoV-2(Covid-19)detection kits,thus providing reference for molecular laboratories.Methods Six domestic detection kits,categorized randomLy from A to F,were selected and applied in the detection of SARS-Cov-2.Five positive nasopharyngeal swab specimens were selected in the study,Ct(threshold cycle)value,ΔRn value and detection of target genes(ORF1ab,E and N gene)and IC gene were analyzed and evaluated prior to and after different dilution folds.Results Ct(threshold cycle)andΔRn value for ORF1ab,IC,E,N gene showed statistically significant differences at different dilution folds for six detection kits.At the dilution of 1∶16,F kit was unable to detect ORF1ab gene.At the dilution of 1∶64,C kit was unable to detect ORF1ab and N gene.At a dilution of 1∶256,A,B and D kits were unable detect ORF1ab and N genes.E kit detected IC,ORF1ab,N and E gene at all dilution folds.Conclusion Detection ability for 6 nucleic acid detection kits varied for low-viral load samples.Performance validation prior selection of kits is recommended.Selection of reagent kits should be based on the aim of the testing and testing subjects.

关 键 词：2019新型冠状病毒 核酸检测 试剂盒 性能比较 

分 类 号：R192.3[医药卫生—卫生事业管理]