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

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

Virol Sin. 2023 Aug;38(4):620-626. doi: 10.1016/j.virs.2023.06.009. Epub 2023 Jul 3.

Authors

Xin-Xin Shen¹, Feng-Yu Li², Meng Qin³, Guo-Hao Zhang⁴, Meng-Yi Zhang¹, Hong Liu⁵, Xiu-Li Sun¹, Zhen-Jiang Xin⁶, Xue-Jun Ma⁷

Affiliations

¹ 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.
² 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.
³ Fengtai District Center for Disease Control and Prevention of Beijing, Beijing, 100071, China.
⁴ Beijing Baicare Biotechnology Co., Ltd., Beijing, 102206, China.
⁵ Shandong University of Technology, School of Life Sciences and Medicine, Zibo, 255000, China.
⁶ Fengtai District Center for Disease Control and Prevention of Beijing, Beijing, 100071, China. Electronic address: ftwjwjkzx@mail.bjft.gov.cn.
⁷ 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. Electronic address: maxj@ivdc.chinacdc.cn.

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.

Keywords: Antigen-test; Nucleic acid self-testing; RT-qPCR; SARS-CoV-2.

Publication types

Multicenter Study

MeSH terms

COVID-19 Testing
COVID-19* / diagnosis
Humans
Reproducibility of Results
SARS-CoV-2* / genetics
Self-Testing
Sensitivity and Specificity