ZEUS ELISA SARS-CoV-2 Antibody Test Systems

ZEUS SARS-CoV-2 IgG Test System Now with FDA Emergency Use Authorization (EUA)

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

The ZEUS ELISA SARS-CoV-2 Test Systems are intended for qualitative detection of antibodies to the SARS-COV-2 virus in human serum and plasma. The ZEUS ELISA SARS-CoV-2 Antibody Test Systems utilize a combination of recombinant spike protein 1 receptor binding domain (S1-RBD) viral protein and recombinant nucleoprotein (N-protein) as the antibody capture antigens.

SARS-CoV-2 Antigens

Have twice the confidence in the test you choose

S1-RBD:  The surface glycoprotein of the virus, termed the spike (S) protein, mediates attachment of the virus to human cells via its receptor‐binding domain (RBD; Wrapp et al., 2020) and mediates fusion of viral and cellular membranes.  Antibodies binding to the spike protein, and especially to the RBD domain, can neutralize SARS‐CoV‐2.

 N-Protein: The nucleocapsid protein (N-protein) is the most abundant protein in coronavirus. The N-protein is a highly immunogenic phosphoprotein, and it is normally very conserved. The N protein of coronavirus is often used as a marker in diagnostic assays. During virion assembly, N protein binds to viral RNA and leads to formation of the helical nucleocapsid. The abundance and high hydrophilicity of N protein are supposed to contribute to potent immunity after coronavirus infection.

Two antigens are better than one

ZEUS’s dual antigen approach is unique as most available tests are limited to one or the other.  By detecting antibodies directed against both the highly immunogenic N-protein and the neutralizing S1-RBD our assay is optimized for superior sensitivity and specificity.

The ZEUS ELISA SARS-CoV-2 IgG Test System has FDA Emergency Use Authorization. The ZEUS ELISA SARS-CoV-2 Total Antibody Test System has been validated per the current FDA EUA guidelines.

ZEUS Universal ELISA Protocol

Scalable to your Laboratory Needs

The ZEUS ELISA SARS-CoV-2- IgG Antibody Test System has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) as a diagnostic test for the qualitative detection of IgG antibodies to the SARS-CoV-2 virus in human serum and plasma. 

The ZEUS ELISA SARS-CoV-2 IgG 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. The assay utilizes a dual antigen combination of recombinant S1 receptor binding domain (RBD) viral protein and recombinant nucleoprotein for optimal performance.   

The SARS-CoV-2 IgG Test System assay follows ZEUS’s universal ELISA assay protocol, developed to harmonize with your existing test menu and volume needs.  Simply put, our new SARS-CoV-2-IgG Antibody assay shares ZEUS’s common components, incubations performed at room temperature and incubation timings which enable your laboratory to multi-task and benefit with faster, flexible test systems designed to make your day easier.

ZEUS has received EUA approval to run the ZEUS ELISA SARS-SoV-2 IgG Test System manually or using the Dynex Agility® Automated ELISA System. The Agility offers high throughput and takes advantage of the SmartKit™ Gold packaging, providing the ability to fully automate the procedure from sample to result in a throughput meeting all laboratory requirements.  The new Test System also includes our proprietary SAVe Diluent, a unique component which changes color when serum is added ensuring no well is missed!

ZEUS SARS-CoV-2 IgG Test System (with FDA EUA):

Clinical performance testing demonstrated:
Positive Percent Agreement – 100%
Negative Percent Agreement – 99.1%

Additional non-clinical performance studies including studies using normal pre-pandemic donors and pre-pandemic potentially cross reactive donors, demonstrated:
Specificity – 98.9%

Product Code: SM9Z7901G

# of test kits per kit: 96

ZEUS SARS-CoV-2 Total Antibody Test System:

Clinical performance testing demonstrated:
Sensitivity – 98.8%
Specificity – 99.1%

Additional submitted data, including studies using normal pre-pandemic donors and potentially pre-pandemic cross reactive donors, demonstrated:
Specificity – 100%

Product Code: SM9Z7901

# of test kits per kit: 96

Wrapp, D., Wang, N., Corbett, K. S., Goldsmith, J. A., Hsieh, C. L., Abiona, O., … McLellan, J. S. (2020). Cryo‐EM structure of the 2019‐nCoV spike in the prefusion conformation. Science367(6483), 1260–1263. doi: 10.1126/science.abb2507.

FDA EUA Disclaimer: This test has been authorized only for the presence of IgG 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.

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