ZEUS ELISA SARS-CoV-2 Total Antibody Test System
The ZEUS ELISA SARS-CoV-2 Total Antibody Test System is an Enzyme-Linked Immunosorbent Assay (ELISA) intended for semi-quantitative detection of total antibody (IgG, IgM, IgA) to the SARS-CoV-2 virus in human serum and plasma (EDTA, Lithium Heparin, Citrate). The ZEUS ELISA SARS-CoV-2 Total Antibody Test System 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. Human 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 ELISA SARS-CoV-2 Total Antibody 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 ELISA SARS-CoV-2 Total Antibody Test System may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
Registrations / Clearances
The ZEUS ELISA SARS-CoV-2 Total Antibody Test System is only for use under the Food and Drug Administration’s Emergency Use Authorization.