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一次实验室新型冠状病毒核酸检测单基因假阳性原因分析

The reason analysis of false positive of single gene in a novel Coronavirus nucleic acid test
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摘要 目的分析一起实验室新型冠状病毒核酸检测单基因假阳性事件产生的原因,避免此类事件再次发生,确保检测结果的准确性,为相关部门制定防治策略和开展工作提供准确的数据参考。方法对试验员、试验试剂耗材、仪器设备、环境条件等因素进行回顾分析,采用排除法查找本次试验出现假阳性的原因。结果导致本次实验假阳性结果的关键是新冠病毒核酸采样管使用的是样本释放剂,未进行核酸提取过程就直接进行PCR扩增。结论建议实验室应严格按照《新型冠状病毒肺炎防控方案》要求,临床标本检测前对由核酸提取试剂、提取仪、扩增试剂、扩增仪等组成的检测系统进行必要的性能验证,对标本特别是重点人群标本进行新冠病毒核酸检测时,采用常规病毒采样管进行样本采集,并选择磁珠法和膜吸附法对标本进行核酸提取后再进行下一步检测,避免不经过核酸提取直接进行PCR扩增。 Objective To analyze the causes of a single gene false positive event of novel Coronavirus nucleic acid detection in laboratory,to avoid the recurrence of such events and to ensure the accuracy of detection results,and to provide accurate data reference for relevant departments to formulate the prevention and control strategies and carry out the work.Methods The factors such as testers,reagent consumables,instruments and equipments,and environmental conditions were analyzed retrospectively,and the false positive reasons in this experiment were found by exclusion method.Results The key to the false positive result of this test was that the sample releasing agent was used in the COVID-19 nucleic acid sample tube,and the PCR amplification was performed directly without the process of nucleic acid extraction.Conclusion It is suggested that the laboratory should strictly fllow the requirements of New Coronavirus Pneumonia Prevention and Control Program,and carry out necessary performance verification on the detection system consisting of nucleic acid extraction reagents,extraction instruments,amplification reagents and amplification instruments etcetera before clinical specimen detection.When conducting the new Coronavirus nucleic acid detection on the samples,especially those from key populations,the routine virus sampling tube should be used for sample collection,and the magnetic bead method and membrane adsorption method should be selected for nucleic acid extraction before the next detection,so as to avoid direct PCR amplification without nucleic acid extraction.
作者 凡小荣 周艳 王梓璇 邓凯元 高丹 FAN Xiaorong;ZHOU Yan;WANG Zixuan;DENG Kaiyuan;GAO Dan(Neijiang Center for Disease Control and Prevention,Neijiang,Sichuan 641199,China)
出处 《医学动物防制》 2023年第10期1018-1020,共3页 Journal of Medical Pest Control
基金 四川省卫生健康委员会医学重大创新项目——新冠肺炎疫情常态化关键技术研究(21ZDYF0511)。
关键词 新型冠状病毒 核酸提取 核酸检测 单基因 假阳性 分析 Novel Coronavirus Nucleic acid extraction Nucleic acid detection Single gene False positive Analysis
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