Development and clinical application of a rapid and sensitive loop-mediated isothermal amplification test for SARS-CoV-2 infection
View ORCID ProfileXuejiao Hu, Qianyun Deng, Junmin Li, Jierong Chen, Zixia Wang, Zhixin Fang, Haijian Li, Yunhu Zhao, Pan Yu, Wenmin Li, Xiaoming Wang, Shan Li, Lei Zhang, Tieying Hou
doi: https://doi.org/10.1101/2020.05.20.20108530
Abstract
Background The outbreak of SARS-CoV-2 urgently requires sensitive and convenient COVID-19 diagnostics to assure the containment and timely treatment of patients. We aimed to develop and validate a novel reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay to detect SARS-CoV-2 in both qualified laboratories and point-of-care settings. Methods Patients with suspected COVID-19 and close contacts between Jan 26 and April 8, 2020, were recruited from two hospitals. Respiratory samples were collected and tested with LAMP and the results were compared with those obtained by RT-qPCR. The inconsistent samples between these two methods were subjected to next-generation sequencing for confirmation. In addition, we tested the RT-LAMP on an asymptomatic COVID-19 carrier and patients with other respiratory viral infections. Results We finally collected a cohort of 129 cases (329 nasopharyngeal swabs) and the independent cohort of 76 patients (152 nasopharyngeal swabs and sputum samples).
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