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一种用于快速检测包括新型冠状病毒在内的19种常见呼吸道病毒的高通量、多指标等温扩增平台

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

作者信息

Xing Wanli, Liu Yingying, Wang Huili, Li Shanglin, Lin Yongping, Chen Lei, Zhao Yan, Chao Shuang, Huang Xiaolan, Ge Shaolin, Deng Tao, Zhao Tian, Li Baolian, Wang Hanbo, Wang Lei, Song Yunpeng, Jin Ronghua, He Jianxing, Zhao Xiuying, Liu Peng, Li Weimin, Cheng Jing

机构信息

Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing 100084, China.

National Engineering Research Center for Beijing Biochip Technology, Beijing 102206, China.

出版信息

Engineering (Beijing). 2020 Oct;6(10):1130-1140. doi: 10.1016/j.eng.2020.07.015. Epub 2020 Sep 5.

Abstract

Fast and accurate diagnosis and the immediate isolation of patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are regarded as the most effective measures to restrain the coronavirus disease 2019 (COVID-19) pandemic. Here, we present a high-throughput, multi-index nucleic acid isothermal amplification analyzer (RTisochip™-W) employing a centrifugal microfluidic chip to detect 19 common respiratory viruses, including SARS-CoV-2, from 16 samples in a single run within 90 min. The limits of detection of all the viruses analyzed by the RTisochip™-W system were equal to or less than 50 copies·μL, which is comparable to those of conventional reverse transcription polymerase chain reaction. We also demonstrate that the RTisochip™-W system possesses the advantages of good repeatability, strong robustness, and high specificity. Finally, we analyzed 201 cases of preclinical samples, 14 cases of COVID-19-positive samples, 25 cases of clinically diagnosed samples, and 614 cases of clinical samples from patients or suspected patients with respiratory tract infections using the RTisochip™-W system. The test results matched the referenced results well and reflected the epidemic characteristics of the respiratory infectious diseases. The coincidence rate of the RTisochip™-W with the referenced kits was 98.15% for the detection of SARS-CoV-2. Based on these extensive trials, we believe that the RTisochip™-W system provides a powerful platform for fighting the COVID-19 pandemic.

摘要

快速准确的诊断以及对感染严重急性呼吸综合征冠状病毒2(SARS-CoV-2)患者的立即隔离被视为遏制2019冠状病毒病(COVID-19)大流行的最有效措施。在此,我们展示了一种高通量、多指标核酸等温扩增分析仪(RTisochip™-W),它采用离心微流控芯片,可在90分钟内单次运行检测来自16个样本中的19种常见呼吸道病毒,包括SARS-CoV-2。RTisochip™-W系统分析的所有病毒的检测限均等于或低于50拷贝·μL,这与传统逆转录聚合酶链反应的检测限相当。我们还证明了RTisochip™-W系统具有重复性好、稳健性强和特异性高的优点。最后,我们使用RTisochip™-W系统分析了201例临床前样本、14例COVID-19阳性样本、25例临床诊断样本以及614例来自呼吸道感染患者或疑似患者的临床样本。检测结果与参考结果匹配良好,反映了呼吸道传染病的流行特征。RTisochip™-W与参考试剂盒检测SARS-CoV-2的符合率为98.15%。基于这些广泛的试验,我们相信RTisochip™-W系统为抗击COVID-19大流行提供了一个强大的平台。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/824b/7833526/d53737d9a683/gr1_lrg.jpg

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