Immunoassay for the quantitative and qualitative detection of specific IgG-class antibodies to the spike protein of SARS-CoV-2.

• Quantitative determination of antibodies to the SARS-CoV-2 spike (S) protein
• Trimeric SARS-CoV-2 Spike antigen
• Intended as an aid to evaluate patients immune status and determine vaccine efficacy
• Calibrators correlate to First WHO International Standards for SARS-CoV-2
• Diagnostic sensitivity and specificity of 99.94% and 99.49% respectively
• Validated for serum, plasma, and finger prick (serum from capillary blood) samples

It is intended to aid in the diagnosis of patients suspected of having COVID-19 disease or asymptomatic presentation of SARS-CoV-2, to monitor antibody levels during and after a COVID-19 infection, and to determine antibody levels before and after a COVID-19 vaccination.