ZEUS Rapid SARS-CoV-2 IgM/IgG Antibody Test System
The ZEUS Rapid SARS-CoV-2 IgM/IgG Test System is a rapid, in vitro diagnostic test for the qualitative detection of IgG and/or IgM antibody to the SARS-CoV-2 (novel 2019 Coronavirus) in human serum, plasma or whole blood collected in CLIA certified laboratories and/or by healthcare workers at the point-of-care. This test is for in vitro diagnostic use only as an aid in the diagnosis of previous exposure to the SARS-CoV-2 virus.
Results are for the detection of SARS CoV-2 antibodies. IgM and/or IgG antibody 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. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
The sensitivity of ZEUS Rapid SARS-CoV-2 IgM/IgG Test System early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
False positive results for ZEUS Rapid SARS-CoV-2 IgM/IgG Test System may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
The ZEUS Rapid SARS-CoV-2 IgM/IgG Test System is only for use under the Food and Drug Administration’s Emergency Use Authorization.