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

作　　者：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 

机构地区：[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]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

出　　处：《Virologica Sinica》2023年第4期620-626,共7页中国病毒学（英文版）

基　　金：funded by the National Key R&D Program of China (2021YFC2301102);National Natural Science Foundation of China (82202593);Natural Science Foundation of Shandong Province,China (ZR2022MH115).

摘　　要：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.

关 键 词：Nucleic acid self-testing SARS-CoV-2 RT-QPCR Antigen-test 

分 类 号：R440[医药卫生—诊断学]