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Engineering >> 2020, Volume 6, Issue 10 doi: 10.1016/j.eng.2020.07.015

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

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

Received: 2020-04-21 Revised: 2020-06-28 Accepted: 2020-07-21 Available online: 2020-09-05

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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 (RTisochipTM-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 RTisochipTM-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 RTisochipTM-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 RTisochipTM-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 RTisochipTM-W with the referenced kits was 98.15% for the detection of SARS-CoV-2. Based on these extensive trials, we believe that the RTisochipTM-W system provides a powerful platform for fighting the COVID-19 pandemic.

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