A Novel Amplification-free SARS-CoV-2 Point-of-care Nucleic Acid Detection System based on Hybrid Capture Fluorescence Immunoassay

Abstract

Herein we presented a novel, rapid and amplification-free SARS-CoV-2 nucleic acid detection system based on hybrid capture fluorescence immunoassay (HC-FIA) technology. The usage of the monoclonal antibody S9.6 in recognizing DNA-RNA double-stranded hybrids enabled the conversion of nucleic acid testing into immunofluorescence carrying on a simple lateral flow dipstick. The established HC-FIA also exhibited satisfactory sensitivity, specificity and great robustness. The clinical evaluation of HC-FIA kit and fluorescence reading device are further processed in three hospitals independently. The results of 734 samples from 670 subjects indicated high consistency between our HC-FIA and quantitative polymerase chain reaction based commercially available kit or clinical diagnosis according to Kappa statistics. Altogether, HC-FIA related method and commercial test kit show unparalleled advantages as time saving, amplification-free, high throughput and portable POCT molecular diagnosis, which facilitates its application as on-site Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid detection in epidemic prevention and control worldwide, especially during the outbreak.