新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)特异性分析  

Specificity of 2019-nCoV nucleic acid detection kit(fluorescence PCR)

作　　者：董江锴 杜金凤 程天龄 黄迎燕 夏小凯 邹勇 张云涛 杨晓明 DONG Jiang-kai;DU Jin-feng;CHENG Tian-ling;HUANG Ying-yan;XIA Xiao-kai;ZOU Yong;ZHANG Yun-tao;YANG Xiao-ming(Shanghai GeneoDx Biotech Co.,LTD.,Shanghai 201700,China;不详)

机构地区：[1]上海捷诺生物科技有限公司,上海201700 [2]长春生物制品研究所有限责任公司,占林长春130012 [3]中国生物技术股份有限公司,北京100029 [4]国家联合疫苗工程技术研究中心武汉生物制品研究所有限责任公司,湖北武汉430207

出　　处：《中国生物制品学杂志》2021年第5期560-565,共6页Chinese Journal of Biologicals

基　　金：“科技助力经济2020”重点专项(沪科[2020]183号)。

摘　　要：目的对上海捷诺生物科技有限公司连续生产的3批新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)的检测特异性进行评价。方法使用地方性人冠状病毒(HKU1、OC43、NL63和229E)、重症急性呼吸综合征冠状病毒(severe acute respiratory syndromecoronavirus,SARS-CoV)、中东呼吸综合征冠状病毒(Middle East respiratory syndrome coronavirus,MERS-CoV)、季节性流感病毒、鼻病毒、腺病毒及肺炎克雷伯菌、结核分枝杆菌等55种常见呼吸道病原体,分组对本试剂盒交叉反应性进行验证;按照国家药品监督管理局医疗器械技术审评中心发布的《2019新型冠状病毒核酸检测试剂注册技术审评要点》要求,选取人黏蛋白、血液(人)、苯福林、羟甲唑啉、氯化钠(含防腐剂)等29种干扰物质对本试剂盒进行抗干扰物质验证。结果连续3批试剂盒交叉反应验证混合阳性样本检测结果均为阳性,阴性样本检测结果均为阴性,准确性符合率为100%,所使用的交叉反应物质对试剂盒检测结果无影响;抗干扰物质验证阳性样本、临界阳性样本检测结果均为阳性,阴性样本检测结果均为阴性,准确性符合率为100%,29种内源/外源干扰物质对本试剂盒检测结果无影响。结论上海捷诺生物科技有限公司生产的新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)对55种常见呼吸道病原体无交叉反应,对宿主自身组织及临床常见呼吸道疾病治疗药物等内源和外源干扰物质具备良好的抗干扰特性,该试剂盒特异性检测结果符合国家新型冠状病毒核酸检测试剂注册标准;且连续生产的3批产品特异性检测结果有较高的稳定性。Objective To evaluate the specificity of three consecutive batches of 2019-nCoV nucleic acid detection kit(fluorescence PCR)manufactured by Shanghai GeneoDx Biotech Co.,LTD. Methods A total of 55 common respiratory pathogens,including endemic human coronaviruses(HKU1,OC43,NL63 and 229 E),severe acute respiratory syndrome conronavirus(SARS-CoV),Middle East respiratory syndrome coronavirus(MERS),seasonal influenza virus,rhinovirus,adenovirus,Klebsiella pneumonia and Mycobacterium tuberculosis,were grouped and used for verification of cross reactivity of the detection kit. According to the requirements in the Key Points of Technical Review for Registration of2019 New Coronavirus Nucleic Acid Detection Reagents issued by Center for Medical Device Evaluation,National Medical Products Administration(NMPA),human mucoprotein,human blood,phenylephrine,oxymetazoline,sodium chloride(including those as preservatives)and other 29 interfering substances were selected to verify the anti-interference substances of this kit. Results In the verification for cross reactivity,the test results of mixed positive samples by the three consecutive batches of kit were positive,while those of negative samples were negative,indicating a coincidence rate of accuracy of 100%. The cross-reactive substances showed no effect on the test result by the kit. All the test results of positive and borderline positive samples were positive,while those of negative samples were negative,indicating a coincidence rate of accuracy of 100%. All the 29 kinds of endogenous/exogenous interfering substances showed no influence on the test results by this kit. Conclusion The new coronavirus 2019-nCoV nucleic acid detection kit(fluorescence PCR method)manufactured by Shanghai GeneoDx Biotech Co.,LTD. showed no cross-reactivity with 55 common respiratory pathogens,while showed anti-interference properties against endogenous and exogenous interfering substances such as host tissue,common respiratory pathogen and common drugs for respiratory diseases in clinic. The s

关 键 词：新型冠状病毒 核酸 试剂盒 荧光PCR 交叉反应性 抗干扰性 稳定性 

分 类 号：R373.1[医药卫生—病原生物学]