Severe acute respiratory syndrome-associated coronavirus IVDs

Intended purpose

The cPass SARS-CoV-2 Neutralization Antibody Detection Kit is a Blocking Enzyme-Linked Immunosorbent Assay (ELISA) intended for the qualitative direct detection of total neutralizing antibodies to SARS-CoV-2 in human serum and K2-EDTA plasma. The cPass SARS-CoV-2 Neutralization Antibody Detection 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 cPass SARS-CoV-2 Neutralization Antibody Detection Kit should not be used to diagnose acute SARS-CoV-2 infection.