ZEUS Scientific Announces FDA Emergency Use Authorization approval for our ELISA SARS-CoV-2 IgG Test System
ZEUS Scientific Announces FDA Emergency Use Authorization Approval for our ELISA SARS-CoV-2 IgG Test System
ZEUS Scientific announced today, October 7, 2020 the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its in vitro diagnostic ELISA test for the qualitative detection of IgG antibodies to the SARS-CoV-2 virus in human serum and plasma. ZEUS has been producing and shipping the SARS-CoV-2 IgG Test System since early June 2020 and has steadily increased production capabilities to keep up with the growing demand. Achieving EUA approval was the next step in ZEUS’s commitment to deliver superior quality COVID-19 antibody detection devices.
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. Using EUA approved RT-PCR assays as the reference method, the ELISA test demonstrated 100% positive agreement. The average days between the PCR test result and the specimen draw was 15.97 days, the earliest being 3 days. A 99.1% negative agreement was demonstrated using a cohort comprised of RT-PCR negative and pre-pandemic patient specimens. More details on the test system performance can be found on our website.
ZEUS has a long history of developing, manufacturing and delivering high quality in vitro diagnostic kits for infectious and autoimmune disease testing for over 40 years. With over 125 FDA cleared assays in our menu, we welcome you to explore our ELISA menu to see how ZEUS is capable of helping your lab today accommodate increased immunoassay testing demand.
The SARS-CoV-2 IgG Test System assay follows ZEUS’s universal ELISA assay protocol. This protocol offers a high degree of flexibility with incubation times (20-30 minutes for sample incubation and conjugate incubation, 10-15 minutes for TMB substrate incubation) allowing for simple, efficient, and flexible automation programming on open pipetting systems. 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!
Test with Confidence. Test with ZEUS. |
For over 40 years, laboratories have trusted ZEUS Scientific to provide high quality in vitro diagnostic immunoassays for numerous infectious diseases. With over 125 FDA cleared assays in our menu, our company has a proven skillset of developing, manufacturing and distributing a family of products to aid in the diagnosis of complex infectious agents including a variety of known viral pathogens.
We have concentrated our focus to the COVID-19 pandemic and the SARS-CoV-2 virus and currently are awaiting the final FDA review of the EUA submitted SARS-CoV-2 Total Antibody Test System, offering laboratories the option to detect IgG, IgA and IgM antibodies to the SARS-CoV-2 virus. Both ZEUS ELISA products are in stock and ready to ship today.
For more information please visit our website or contact our sales team. To order, call 1.800.286.2111 or email orders@zeusscientific.com and ask for Product Code SM9Z7901G.
Sincerely,
The ZEUS Family
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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