ZEUS ELISA SARS-CoV-2 Antibody Test Systems

ZEUS SARS-CoV-2 IgG Test System

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

The ZEUS ELISA SARS-CoV-2 Test Systems are intended for semi-quantitative 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 Antibody Test Systems have been validated per the current FDA EUA guidelines.

ZEUS Universal ELISA Protocol

Scalable to your Laboratory Needs

The ZEUS ELISA SARS-CoV-2 Antibody Test Systems follow our universal ELISA protocol, developed to harmonize with your existing test menu and volume needs.  Simply put, our new SARS-CoV-2 Antibody assays share 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. The assays are already validated on the Dynex DS2®, DSX® and Agility® platforms.  The Agility offers the highest throughput and takes advantage of the SmartKit Gold packaging.  The Agility can process 7 full microtiter plates in 8 hours, producing 630 patient results.  The SmartKit Gold packaging reduces hands on technician time by 60% when using the Agility. The new Test Systems also include our patented SAVe Diluent, a unique component which changes color when serum is added, ensuring no well is missed!

ZEUS Scientific has notified FDA that the tests have been validated according to FDA guidelines established for serological assays, meeting the criteria to be distributed and are available now.

Clinical performance studies were performed for each assay using four separate cohorts of clinical characterized specimens. Specificity was further evaluate by running both normal pre-pandemic donors and potentially pre-pandemic cross reactive donors.

ZEUS SARS-CoV-2 IgG Test System:

Clinical performance testing demonstrated:
Sensitivity – 96.5%
Specificity – 100%

Additional submitted data, including studies using normal pre-pandemic donors and potentially pre-pandemic 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.

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