ZEUS Scientific ELISA™ SARS-CoV-2 IgG Test System Receives Expanded Automation Claims Through FDA EUA
BRANCHBURG, N.J., May 20, 2021 (Newswire.com) - ZEUS Scientific announced today that it has received Emergency Use Authorization (EUA) for additional automation claims from the U.S. Food and Drug Administration (FDA) for its in vitro ELISA diagnostic test for the qualitative detection of IgG antibodies to the SARS-CoV-2 (Novel 2019) coronavirus 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 that detects immune responses that other antibody tests may miss.
The SARS-CoV-2 IgG Test System was first granted EUA in October of 2020 to run manually or using the Dynex Agility® Automated ELISA System. The FDA has extended this EUA to now include the Dynex DS2® and Dynex DSX® instruments. Combined with our recent additional FDA EUA ZEUS ELISA SARS-CoV-2 Total Antibody Test System, ZEUS now provides a comprehensive portfolio of FDA EUA ELISA SARS-CoV-2 antibody tests, which includes validated full automation on the Dynex Technologies suite of instruments (DS2®, DSX®, Agility®). Achieving these EUA authorizations was the next step in ZEUS's commitment to deliver superior quality COVID-19 antibody detection tests and providing labs additional solutions suited to their workflow needs.
The Dynex Agility® offers the highest throughput and takes advantage of the SmartKit™ Gold packaging, providing the ability to fully automate the procedure from sample to result with a throughput meeting all laboratory requirements. Both assays follow ZEUS's universal ELISA assay protocol. This protocol offers a high degree of flexibility with incubation times allowing for simple, efficient, and flexible automation programming on open pipetting systems.
For over 40 years, laboratories have trusted ZEUS Scientific to provide high-quality in vitro diagnostic immunoassays for numerous infectious diseases. With over 125 U.S. 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.
For more information, please visit ZeusCovid.com or email sales@zeusscientific.com for pricing today.
FDA EUA Disclaimer: These tests have been authorized only for the presence of IgG antibodies and Total antibodies against SARS-CoV-2, not for any other viruses or pathogens. These tests have been authorized by FDA under an EUA for use by authorized laboratories. These tests have not been FDA cleared or approved; these tests are 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.
Source: ZEUS Scientific