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％,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.
基金项目
National Key R&D Program of China(2021YFC2301102)
National Natural Science Foundation of China(82202593)
Natural Science Foundation of Shandong Province,China(ZR2022MH115)
NETL
NSTL
万方数据