Preliminary establishment and evaluation of a rapid detection method for GII human norovirus based on time-resolved fluorescence chromatography.

Human norovirus is the leading cause of non-bacterial gastroenteritis worldwide in all age groups. In this study, a rapid, high-sensitivity and quantitative detection method for VP1 protein of norovirus GII was developed based on time-resolved fluorescence microsphere immunochromatography. The optimal labeling amount and coated antibody concentration of norovirus monoclonal antibody were 10 μg and 1.5 mg mL, respectively. The best detection time was 15 min after sample addition. The detection of NoV GII VP1 protein had a good linear relationship in the range of 2.5 ng mL-320 ng mL ( = 0.6784 - 1.1443, = 0.9935), and the lowest limit of detection was 0.61 ng mL. There was no cross reaction with rotavirus type A and enteric adenovirus type 40 lysate. In 88 clinical samples, the positive coincidence rate was 97.06%, the negative coincidence rate was 96.27%, and the total coincidence rate was 96.60%. The area under the subject operating characteristic curve was 0.9670 and the 95% confidence interval was (0.9289,1.000). Therefore, this study established a rapid, sensitive and wide detection range of GII human norovirus detection method, which can provide an auxiliary diagnostic method for early clinical diagnosis of norovirus and population screening.