SCoV-2 Detect™ IgG Rapid Test
CE Marked. For Export Use Only.
The SCoV-2 Detect™ IgG Rapid Test is an in vitro lateral flow chromatographic immunoassay intended for the qualitative detection of IgG antibodies against severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) in human serum, plasma (sodium citrate, K2 EDTA and sodium heparin), venous whole blood (sodium citrate, K2 EDTA and sodium heparin), or capillary (fingerstick) whole blood. The SCoV-2 Detect™ IgG 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. The SCoV-2 Detect™ IgG Rapid Test should not be used to diagnose or exclude acute SARS-CoV-2 infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.