摘要
目的针对2019-nCoV检测试剂在实际使用中遇到的假阳性以及多次结果不一致等情况,对市场上5种主要的核酸检测试剂进行了对比研究。方法2020年5月选择经过国家食品药品监督管理总局(CFDA)批准的市场上常用的5种2019-nCoV核酸检测试剂A、B、C、D、E,采用回顾性研究,前期在实际检测中收集的84份样本(28份出现过阳性扩增、56份阴性)进行扩增分析。对检测阳性率进行χ^(2)检验,并对比检测一致性,分析其原因。结果5种试剂盒A、B、C、D、E的检测阳性率分别为29.76%(25/84)、23.80%(20/84)、30.95%(26/84)、29.76%(25/84)和29.76%(25/84)(P>0.05)。5种试剂盒的一致性为67.86%。结论所选择5种2019-nCoV核酸检测试剂盒间阳性率无差异,但是一致性偏低。
Objective In view of the false positives encountered in the actual use of 2019-nCoV detection reagent and the repeated inconsistent results,a comparative study was conducted on 5 major nucleic acid detection reagents in the market.Methods The 52019-nCoV nucleic acid detection reagents(A,B,C,D,E)commonly used in the market approved by the CFDA were selected,and the 84 samples(28 positive amplification and 56 negative)collected in the actual test were analyzed by retrospective study.Carry on the χ^(2) test to the positive rate of the test,compare the consistency of the test,and analyze the reasons.Results The 5 reagents A,B,C,D,E positive rates were 29.76%(25/84),23.80%(20/84),30.95%(26/84),29.76%(25/84)and 29.76%(25/84)respectively(P>0.05).The consistency of the 5 kits was67.86%.Conclusion There is no difference in the positive rates among the 52019-nCoV nucleic acid detection kits selected,but their consistency is low.
作者
石华
孙立荣
马玲
张烨
SHI Hua;SUN Li-rong;MA Ling;ZHANG Ye(Datong City Center for Disease Control and Prevention,Datong,Shanxi,037008,China;不详)
出处
《预防医学论坛》
2021年第7期502-504,共3页
Preventive Medicine Tribune
基金
大同市科学技术局项目:2019新型冠状病毒多重荧光PCR核酸检测方法的评价和筛选。
