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

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

doi:10.1016/j.virs.2023.06.009

August 2023

Citation: 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. Multicenter evaluation of a simple and sensitive nucleic acid self-testing for SARS-CoV-2 .VIROLOGICA SINICA, 2023, 38(4) : 620-626. http://dx.doi.org/10.1016/j.virs.2023.06.009

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

Xin-Xin Shen ^a ,
Feng-Yu Li ^a,b ,
Meng Qin ^c ,
Guo-Hao Zhang ^d ,
Meng-Yi Zhang ^a ,
Hong Liu ^e ,
Xiu-Li Sun ^a ,
Zhen-Jiang Xin ^{c
,,} ,
Xue-Jun Ma ^{a
,,}

a. 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;
b. Hebei Medical University, Shijiazhuang, 050031, China;
c. Fengtai District Center for Disease Control and Prevention of Beijing, Beijing, 100071, China;
d. Beijing Baicare Biotechnology Co., Ltd., Beijing, 102206, China;
e. Shandong University of Technology, School of Life Sciences and Medicine, Zibo, 255000, China

Corresponding author: Zhen-Jiang Xin, ftwjwjkzx@mail.bjft.gov.cn
Xue-Jun Ma, maxj@ivdc.chinacdc.cn
Received Date: 04 February 2023
Accepted Date: 29 June 2023
Available online: 03 July 2023

Abstract

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%, respectively, 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-testing
- , SARS-CoV-2
- , RT-qPCR
- , Antigen-test

Electronic Supplementary Material

10.1016j.virs.2023.06.009-ESM1.docx
10.1016j.virs.2023.06.009-ESM2.mp4

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