Clinical performance

The detection reagent was compared with the neutralization test with the positive judgment value of NT50 of 30 in 350 cases, including pre-immunization, post-immunization and convalescent serum tests. Compared with a neutralization titer greater than 30, the relative sensitivity was 96.7% (95% CI 92.0% - 92.8%), the relative specificity was 97.9% (95% CI 97.90% - 99.4%), and the total coincidence rate was 97.4%.

Explanation for the results

1．Positive：Two purplish red bands in the T line and C line area in the observation window, indicating that the 2019-nCoV neutralizing antibody in the sample is positive. 2．Negative：One purplish red band in the C line area in the observation window, no band in the T line area, indicating that the 2019-nCoV neutralizing antibody in the sample is negative. Invalid：No purplish red band in the C line, with or no band in the T line, indicating that the test is invalid.