基于变性泡介导的加速链交换扩增技术在新型冠状病毒核酸检测中的性能分析  

A Rapid Nucleic Acid Test of SARS-CoV-2 Based on Accelerated Strand Exchange Amplification

作　　者：陈磊 赵晓丽 潘兆宝 程娟 王怀杰 曲梅花 石超 杨国儒 马翠萍[2] CHEN Lei;ZHAO Xiaoli;PAN Zhaobao;CHENG Juan;WANG Huaijie;QU Meihua;SHI Chao;YANG Guoru;MA Cuiping(Department of Laboratory Medicine,Translational Medical Center,Departemtn of Pulmonary and Critical Care Medicine,Weifang Second People's Hospital,Weifang 261041,China;Key Laboratory of Optic-Electric Sensing and Analytical Chemistry for Life Science,MOE,Shandong Provincial Key Laboratory of Biochemical Engineering,College of Marine Science and Biological Engineering,Qingdao Nucleic Acid Rapid Detection Engineering Research Center,Qingdao University of Science and Technology,Qingdao 266042,China;College of Life Sciences,Qingdao Nucleic Acid Rapid Testing International Science and Technology Cooperation Base,Department of Pathogenic Biology,School of Basic Medicine,The Affiliated Hospital,Qingdao University,Qingdao 266071,China)

机构地区：[1]潍坊市第二人民医院检验科,转化医学中心,呼吸与危重症医学科,山东潍坊261041 [2]青岛科技大学教育部生命科学光电传感与分析化学重点实验室,山东省生化工程重点实验室:海洋科学与生物工程学院,青岛核酸快速检测工程研究中心,山东青岛266042 [3]青岛大学生命科学学院,核酸快速检测国际科技合作基地,基础医学院,附属医院临床检验科,山东青岛266071

出　　处：《青岛科技大学学报（自然科学版）》2024年第2期23-28,37,共7页Journal of Qingdao University of Science and Technology:Natural Science Edition

基　　金：国家重点研发计划项目(2018YFE0113300);山东省自然科学基金重点项目(ZR2020KH030);潍坊市卫健委科技项目(WFWSJK-2020-063,WFWSJK-2020-004,WFWSJK-2020-077);潍坊市2020年新冠病毒疫情防控专项项目(2020YQFK017).

摘　　要：运用变性泡介导的加速链交换扩增技术,建立一种新型冠状病毒(SARS-CoV-2)核酸检测的新方法。收集潍坊市第二人民医院检验科1492例疑似SARS-CoV-2样本,以荧光定量PCR结果为参考,计算ASEA-SARS-CoV-2核酸检测试剂盒检测新型冠状病毒样本结果的敏感性、特异性、阳性预测值(PPV)、阴性预测值(NPV)。结果表明:ASEA可在30min内完成核酸扩增,检测限为1000拷贝·mL^(-1)。敏感性为96.7%,特异性为99.9%。该方法可在30min内检测SARS-CoV-2,而之前报道的传统qPCR方法需要数小时。建立了一种基于变性泡介导的加速链交换扩增技术检测新型冠状病毒的新方法。Using the technique ofaccelerated strand exchange amplification(ASEA),a new method for the detection of novel coronavirus nucleic acid was established.Retrospective analysis was performed on 1492 samples from the laboratory department of Weifang Second People's hospital.The sensitivity,specificity,positive predictive value(PPV),negative predictive value(NPV),and agreement rate of the detection results of the SARS-CoV-2 nucleic acid detection kit were calculated.The nucleic acid detection kit could complete nucleic acid amplification within 30 min with a detection limit of 2 copies per reaction.Among the 1492 samples from patients with respiratory tract infections respiratory tract infections,the sensitivity of this kit was 96.7%,and the specificity was 99.9%.This kit for detecting SARS-CoV-2 within only 30 min,while the previously reported traditional qPCR method took several hours.We have proved a rapid nucleic acid detection kit for detecting SARSCoV-2 with accelerating strand exchange amplification.

关 键 词：加速链交换扩增 新型冠状病毒 核酸检测 RNA检测 

分 类 号：R37[医药卫生—病原生物学]