ErbaLisa covid-19 igG CE-marked Enzyme Immunoassay (ELISA) kit for the detection of IgG antibodies to SARS-CoV-2 in human serum Erba Mannheim and Calbiotech have developed a reliable and automation-friendly COVID-19 ELISA, allowing for comprehensive and accurate IgG antibody assessment. Our solid phase assay uses proven technology, and total incubation time is 50 min at room temperature with a simple one step serum dilution. ErbaLisa COVID-19 assays are built for superior performance and reliable interpretation of results. This kit has been granted Notification Status by the FDA, under product code QKO. Our submission number is D386770. In the first 14 days of the onset of infection with SARS-CoV-2 patient results may be negative for IgG antibodies. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.