A High-Throughput, Multi-Index Isothermal Amplification Platform for Rapid Detection of 19 Types of Common Respiratory Viruses Including SARS-CoV-2  

一款用于快速检测包括SARS-CoV-2在内的19种常见呼吸道病毒的高通量、多指标等温扩增平台

作　　者：Wanli Xing Yingying Liu Huili Wang Shanglin Li Yongping Lin Lei Chen Yan Zhao Shuang Chao Xiaolan Huang Shaolin Ge Tao Deng Tian Zhao Baolian Li Hanbo Wang Lei Wang Yunpeng Song Ronghua Jin Jianxing He Xiuying Zhao Peng Liu Weimin Li Jing Cheng 邢婉丽;刘莹莹;王会丽;李尚霖;林勇平;陈蕾;赵艳;晁爽;黄小兰;葛少林;邓涛;赵添;李宝莲;王瀚博;王磊;宋云鹏;金荣华;何建行;赵秀英;刘鹏;李为民;程京

机构地区：[1]Department of Biomedical Engineering,School of Medicine,Tsinghua University,Beijing 100084,China [2]National Engineering Research Center for Beijing Biochip Technology,Beijing 102206,China [3]CapitalBio Technology,Beijing 101111,China [4]CapitalBio Corporation,Beijing 102206,China [5]Department of Basic Medical Sciences,School of Medicine,Tsinghua University,Beijing 100084,China [6]Department of Laboratory Medicine,First Affiliated Hospital of Guangzhou Medical University,Guangzhou 510120,China [7]Department of Neurology,West China Hospital,Sichuan University,Chengdu 610041,China [8]Clinical Laboratory Center,Beijing Youan Hospital Capital Medical University,Beijing 100069,China [9]Department of Pediatrics,Beijing Tsinghua Changgung Hospital,School of Clinical Medicine,Tsinghua University,Beijing 102218,China [10]Experiment Center,Capital Institute of Pediatrics,Beijing 100020,China [11]President's Office,Beijing Youan Hospital,Capital Medical University,Beijing 100069,China [12]Department of Cardiothoracic Surgery,State Key Laboratory of Respiratory Disease,China Clinical Research Center for Respiratory Disease,Guangzhou Institute of Respiratory Health,First Affiliated Hospital of Guangzhou Medical University,Guangzhou 510120,China [13]Department of Clinical Laboratory,Beijing Tsinghua Changgung Hospital,School of Clinical Medicine,Tsinghua University,Beijing 102218,China [14]Department of Respiratory and Critical Care Medicine,West China Hospital,Sichuan University,Chengdu 610041,China

出　　处：《Engineering》2020年第10期1275-1286,共12页工程（英文）

基　　金：科技部国家重点研究发展计划(2020YFC0847400);清华大学(20201080055)和广州呼吸健康研究院(2020GIRHHMS02和2020GIRHHMS03)预防与控制COVID-19科学技术应急响应项目的资助。

摘　　要：快速、准确地诊断以及及时对感染严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的患者进行隔离被认为是抗击新冠病毒肺炎(COVID-19)大流行的最有效的措施。本文介绍了一款高通量、多指标的等温扩增检测平台(RTisochip^TM-W),该平台使用离心式微流控芯片,在90min内即可完成一次运行,从16个样本中检测出包括SARS-CoV-2在内的19种常见呼吸道病毒。通过RTisochip^TM-W系统检测的所有病毒的检出限均等于或小于50拷贝·μL^-1,与常规逆转录聚合酶链反应(RT-PCR)灵敏度相当。该系统具有重复性好、鲁棒性强和特异性高的优点。最后,使用RTisochip^TM-W系统对201例临床前样本、14例COVID-19阳性临床样本、25例临床确诊样本以及614例来自呼吸道感染或疑似感染的患者的临床样本进行了测试。测试结果与临床诊断结果吻合良好,也反映出呼吸道传染病的流行特征。在对SARS-CoV-2的诊断上,RTisochip^TM-W系统与参考试剂盒的一致性达到98.15%。基于大量的测试结果,我们相信RTisochip^TM-W系统是一款抗击COV ID-19大流行的强有力工具。

关 键 词：COVID-19 SARS-CoV-2 微流控 核酸检测 等温扩增 

分 类 号：R440[医药卫生—诊断学] R563.1[医药卫生—临床医学]