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

Engineering ›› 2020, Vol. 6 ›› Issue (10) : 1130 -1140. DOI: 10.1016/j.eng.2020.07.015

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

^b National Engineering Research Center for Beijing Biochip Technology, Beijing, 102206, China

^c CapitalBio Technology, Beijing, 101111, China

^d CapitalBio Corporation, Beijing, 102206, China

^e Department of Basic Medical Sciences, School of Medicine, Tsinghua University, Beijing, 100084, China

^f Department of Laboratory Medicine, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510120, China

^g Department of Neurology, West China Hospital, Sichuan University, Chengdu, 610041, China

^h Clinical Laboratory Centre, Beijing YouAn Hospital, Capital Medical University, Beijing, 100069, China

ⁱ Department of Pediatrics, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, 102218, China

^j Experiment Center, Capital Institute of Pediatrics, Beijing, 100020, China

^k President’s Office, Beijing YouAn Hospital, Capital Medical University, Beijing, 100069, China

^l 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

^m Department of Clinical Laboratory, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, 102218, China

ⁿ Department of Respiratory and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, 610041, China

^* These authors contributed equally to this work.

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Received	Accepted	Published
2020-04-21		2020-01-24
Issue Date	Revised Date
2024-06-14

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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^TM-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^TM-W system were equal to or less than 50 copies·μL⁻¹, which is comparable to those of conventional reverse transcription polymerase chain reaction. We also demonstrate that the RTisochip^TM-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^TM-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^TM-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^TM-W system provides a powerful platform for fighting the COVID-19 pandemic.

Keywords

Coronavirus disease 2019 / Severe acute respiratory syndrome coronavirus 2 / Microfluidics / Nucleic acid testing / Isothermal

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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. A High-Throughput, Multi-Index Isothermal Amplification Platform for Rapid Detection of 19 Types of Common Respiratory Viruses Including SARS-CoV-2. Engineering, 2020, 6(10): 1130-1140 DOI:10.1016/j.eng.2020.07.015