This immunoassay kit operated on the fully automatic chemiluminescence analyzer is intended for semi-quantitative detection of total neutralizing antibodies that could block the interaction between the RBD domain of SARS-CoV-2 and the human ACE2 in human serum and plasma.

        The Kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection or vaccination. The kit should not be used to diagnose acute SARS-CoV-2 infection.

        Results are for the detection of SARS-CoV-2 total neutralizing antibodies. Antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of neutralizing antibodies are present post-infection or vaccination is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.