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

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

SUBMITTER: Shen XX 

PROVIDER: S-EPMC10436039 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature