This clinical study is designed to test the efficacy and robustness of the Novir 2019-nCoV IgM/IgG Antibody Test (Colloidal Gold) in a point-of-care (POC) setting to support the growing need for rapid screening of patients to detect antibodies. The COVID-19 SARS-CoV IgM/IgG antibody rapid test is an immunochromatographic lateral flow assay intended for qualitative detection of IgM and IgG antibodies to SARS-CoV-2 in human venipuncture and finger stick whole blood. The COVID-19 SARS-CoV IgM/IgG antibody rapid test is intended for use 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.
Results are for the detection of SARS CoV-2 antibodies. IgM and IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. All the results will be compared to an FDA EUA authorized PCR test results and may also be compared to an FDA EUA authorized ELISA, CMIA, or other antibody test.
The study results will be used for an EUA application to the FDA.
