Celltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test is an in vitro diagnostic test based on an immunochromatographic assay. It is designed for qualitative detection of Immunoglobulin G and Immunoglobulin M antibodies of the novel Coronavirus (COVID-19) in human whole blood, plasma or serum. Celltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Celltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test should not be used to diagnose acute SARS-CoV-2 infection.