ZEUS ELISA SARS-CoV-2 Total Antibody (IgG, IgM, IgA) Test System

Intended Use

The ZEUS ELISA SARS-CoV-2 Total Antibody Test System is an Enzyme-Linked Immunosorbent Assay (ELISA) intended for the qualitative detection of total antibodies to the SARS-CoV-2 virus in human serum and plasma (dipotassium EDTA, lithium heparin and sodium citrate) run manually or using the Dynex AGILITY, Dynex DSX or Dynex DS2 automated ELISA Systems. 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 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.  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.

FDA EUA Disclaimer: The ZEUS ELISA SARS-CoV-2 Total Antibody test has been authorized only for the presence of total antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has not been FDA cleared or approved; This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.