首页|Multicenter evaluation of a simple and sensitive nucleic acid self-testing for SARS-CoV-2

Multicenter evaluation of a simple and sensitive nucleic acid self-testing for SARS-CoV-2

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A rapid and accurate COVID-19 diagnosis is a prerequisite for blocking the source of infection as soon as possible and taking the appropriate medical action.Herein,we developed GeneClick,a device for nucleic acid self-testing of SARS-CoV-2,consisting of three modules:a sampling kit,a microfluidic chip-based disposable cartridge,and an amplification reader.In addition,we evaluated the clinical performance of GeneClick using 2162 nasal swabs collected at three medical institutions,using three commercial RT-qPCR kits and an antigen self-test as references.Compared to RT-qPCR,the sensitivity and specificity of the GeneClick assay were 97.93％and 99.72％,respec-tively,with a kappa value of 0.979(P＜0.01).Of the 2162 samples,2076 were also tested for SARS-CoV-2 antigens.Among the 314 positive samples identified by GeneClick assay,63 samples were undetected by antigen tests.Overall,the GeneClick nucleic acid self-test demonstrated higher accuracy than the antigen-based detection.Based on the additional features,including simple operation,affordable price,portable device,and reliability of smartphone APP-driven sampling and result reporting,GeneClick offers a powerful tool for field-based SARS-CoV-2 detection in primary healthcare institutions or at-home use.

Nucleic acid self-testingSARS-CoV-2RT-qPCRAntigen-test

Xin-Xin Shen、Feng-Yu Li、Meng Qin、Guo-Hao Zhang、Meng-Yi Zhang、Hong Liu、Xiu-Li Sun、Zhen-Jiang Xin、Xue-Jun Ma

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NHC Key Laboratory of Medical Virology and Viral Diseases,National Institute for Viral Disease Control and Prevention,Chinese Center for Disease Control and Prevention,Beijing,102206,China

Hebei Medical University,Shijiazhuang,050031,China

Fengtai District Center for Disease Control and Prevention of Beijing,Beijing,100071,China

Beijing Baicare Biotechnology Co.,Ltd,Beijing,102206,China

Shandong University of Technology,School of Life Sciences and Medicine,Zibo,255000,China

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National Key R&D Program of ChinaNational Natural Science Foundation of ChinaNatural Science Foundation of Shandong Province,China

2021YFC230110282202593ZR2022MH115

2023

10.1016/j.virs.2023.06.009

中国病毒学
中国科学院武汉病毒研究所，中国微生物学会

中国病毒学

CSTPCDCSCD
影响因子：0.393
ISSN：1674-0769
年,卷(期)：2023.38(4)
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