2种国产新型冠状病毒核酸检测试剂检测结果的比较与分析  

Comparative analysis of detection performance between two domestic new coronavirus nucleic acid detection reagents

作　　者：丁晓燕 柯志意 朱秀云[1] 郑海霞[1] 袁静[1] 潘延超 张明霞[1] DING Xiaoyan;KE Zhiyi;ZHU Xiuyun;ZHENG Haixia;YUAN Jing;PAN Yanchao;ZHANG Mingxia(The Third people's Hospital of Shenzhen Institute of Hepatology,Shenzhen,Guangdong,China,518112)

机构地区：[1]深圳市第三人民医院肝病研究所,广东深圳518112

出　　处：《分子诊断与治疗杂志》2020年第3期275-278,共4页Journal of Molecular Diagnostics and Therapy

基　　金：深圳市第三人民医院三名工程团队(SZSM201512005)。

摘　　要：目的对不同的新型冠状病毒(SARS-CoV-2)核酸检测试剂的检测结果进行比较和分析,以供实验室参考。方法收集本院2月9日至2月11日期间共101例检测SARS-CoV-2核酸的临床样本,用两种国产试剂盒进行平行检测,根据检测结果比较试剂盒差异。结果 101例样本中试剂A阳性32例(阳性率31.68%),阴性56例(阴性率55.45%),试剂B阳性35例(阳性率34.65%),阴性53例(阴性率52.48%),两组对比,差异无统计学意义(c2=0.2169,P=0.8972)。试剂单通道结果统计发现两种试剂盒N检测位点检出率较ORF1a/b检测位点检出率高,其中试剂A两个通道的检出率分别为ORF1a/b:31.68%,N:44.55%;试剂B为ORF1a/b:35.64%,N:40.59%且14例确诊患者检测结果显示两种试剂盒对于N位点检出的Ct值非常接近。结论本研究中两种SARS-CoV-2核酸检测试剂的检出率无明显差异,两种试剂盒的N位点检出率都较ORF1a/b高,且两种试剂盒对于N基因检测结果相似。Objective To compare and analyze the detection results of different novel coronavirus(SARS-CoV-2)nucleic acid detection reagents for reference in the laboratory. Methods A total of 101 remaining nucleic acid samples were collected for clinical testing in our hospital on February 9 and 11,and two domestic kits were used for parallel testing to perform nucleic acid amplification. The performance of the samples was compared according to the test results of each reagent. Results Among the 101 samples,32 were positive for reagent A(positive rate 31.68%),56 were negative(negative rate 55.45%),35 were positive for reagent B(positive rate 34.65%),and 53 were negative(negative rate 52.48%). The difference was not statistically significant(c2=0.2169,P=0.8972). According to the single channel results of the kit,the detection rate of the N detection site of the two kits was higher than that of ORF1 a/b,the detection rates of two channels of reagent A were ORF1 ab:31.68%,N:44.55%,respectively. Reagent B were ORF1 a/B:35.64%,N:40.59%.The detection results of the N detection site of the two kits were very similar in the samples of 14 confirmed patients. Conclusion There is no significant difference in the detection rates of the two 2019-ncov nucleic acid detection reagents. The detection rates of the N sites of the two kits arehigher than those of ORF1 ab,and the results of the two kits for the N gene detection are similar.

关 键 词：新型冠状病毒 核酸检测 试剂盒 

分 类 号：R563.1[医药卫生—呼吸系统] R440[医药卫生—内科学]