Abstract:[Background] Norovirus is one of the most important pathogens causing acute gastroenteritis, and it is rich in genetic diversity. [Objective] This study intends to establish a simple and rapid method for colloidal gold immunochromatographic assay of Norovirus epidemic strains. [Methods] Monoclonal antibody 1B10 against Norovirus capsid protein labeled with colloidal gold. Monoclonal antibody 1D6 against Norovirus capsid protein and goat anti-mouse antibody was blotted on nitrocellulose membrane as test line and control line, respectively. Optimize the assembly conditions of the test strip, including the labeling pH, the concentration of the gold-labeled antibody and the concentration of the test line and control line. Evaluate the performance of the method, including sensitivity test, specificity test, shelf life test and coincidence rate. Finally, the method was applied to the detection of clinical samples to evaluate its application effect. [Results] The limit of detection was 5.9×105 copies/μL. This method did not cross-react with common diarrhea viruses such as Rotavirus, Astrovirus, Adenovirus, and Enterovirus. This method has a good repeatability. The test strip can be stored for at least one year at room temperature. A total of 24 samples were detected by the method. The positive coincidence rate between the test strip and the real-time fluorescence quantitative RT-PCR method was about 83% (15/18). Epidemic strains GII.2, GII.3, GII.4, and GII.17 were successfully detected by the method. [Conclusion] The established colloidal gold test strip method has good specificity and stability, and can be used for the detection of Norovirus epidemic strains and large-scale epidemiological investigation.
