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

. doi: 10.1016/j.virs.2023.06.009

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

简单而敏感的SARS-CoV-2核酸自检装置的多中心评估

申辛欣 ^a ,
李逢钰 ^a,b ,
秦萌 ^c ,
张国豪 ^d ,
张梦怡 ^a ,
刘红 ^e ,
孙秀丽 ^a ,
信振江 ^c,, ,
马学军 ^a,,

a. 中国疾病预防控制中心病毒病预防控制所;
b. 河北医科大学;
c. 北京市丰台区疾病预防控制中心;
d. 北京百康芯生物科技有限公司;
e. 山东理工大学

通讯作者： 信振江, ftwjwjkzx@mail.bjft.gov.cn; 马学军, maxj@ivdc.chinacdc.cn
收稿日期： 2023-02-04
录用日期： 2023-06-29

摘要

快速准确的COVID-19诊断是尽快阻断感染源和采取适当医疗措施的前提。在此，我们开发了GeneClick，一种用于SARS-COV-2核酸自我检测的设备，由三个模块组成：一个采样包、一个基于微流控芯片的一次性试剂盒和一个扩增阅读器。此外，我们使用在三家医疗机构收集的2162份鼻拭子，以三种商业RT-qPCR试剂盒和一种抗原自检法为参考，评估了GeneClick的临床表现。与RT-qPCR相比，GeneClick检测的敏感性和特异性分别为97.93%和99.72%，Kappa值为0.979（P < 0.01）。在2162个样本中，有2076个样本还进行了SARS-COV-2抗原检测。在通过GeneClick检测确定的314个阳性样本中，有63个样本未被抗原检测发现。我们的结果表明GeneClick核酸自我检测设备显示出比基于抗原的检测更高的准确性。GeneClick其他的特点还包括操作简单、价格合理、设备便携、基于智能手机APP的采样监督和结果自动报告。GeneClick为基层医疗机构的现场SARS-COV-2检测或在家使用提供了一个强大的工具。
- 核酸自我检测
- , SARS-CoV-2
- , RT-qPCR
- , 抗原检测

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

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

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

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