Communication: Correlation of Point of Care SARS-CoV-2 Serological Assay with Quantitative ELISA.

ABSTRACT

Due to the COVID-19 pandemic, the Food and Drug Administration issued an Emergency Use Authorization to permit developers of certain serological tests to market their product prior to a comprehensive review. Nonetheless, the reliability of these assays is of great importance in order to be useful as a tool in estimating the relative proportions of different populations that have been exposed to SARS-CoV-2. We provide a sampling of 145 individuals from an ambulatory setting simultaneously tested with a qualitative point of care rapid finger prick Lateral Wave® IgM and IgG assay and a sample for the Mayo Clinic enzyme linked immunosorbent assay (ELISA) IgM/IgG antibody assay. Significant discrepancies did exist between the purported antibody responses as demonstrated by each assay.