Used for the qualitative measurement of total antibody (including IgG and IgM) to SARS-CoV-2 in human serum and plasma (K2 EDTA) samples from patients suspected of COVID-19 by a healthcare provider, using VITROS™ ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS™ 5600/XT 7600 Integrated Systems.