The OnSite COVID-19 IgG/IgM Rapid Test is a single use lateral flow immunoassay rapid test intended for qualitative detection and differentiation of anti-SARS-CoV-2 IgG and IgM antibodies in human serum and plasma or whole blood containing EDTA, heparin or citrate anti-coagulants. The OnSite COVID-19 IgG/IgM 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. For prescription use only. For in vitro diagnostic use only.
Currently, the laboratory method for detecting SARS-CoV-2 infection is RT-PCR. However, this method requires sophisticated equipment and highly trained laboratory technicians. Moreover, viral load decreases rapidly 9 or 10 days after onset of symptoms. During the acute phase of infection, the titer of IgM to SARS-CoV-2 rises rapidly and peaks around 2-3 weeks after the infection. SARS-CoV-2 specific IgG antibodies appear shortly after IgM and persist for months. It is unknown if SARS-CoV-2 infection leads to lifetime immunity or if a 2nd infection is possible. Nevertheless, the SARS-CoV-2 specific antibodies are useful markers for immune response and epidemiologic survey.