Zeus Scientific is seeking emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 IgG antibody test.

The company has submitted an application for EUA for ZEUS ELISA SARS-CoV-2 IgG Test System for the semi-quantitative detection of IgG antibodies to the novel coronavirus in human serum and plasma.

Zeus’ in vitro ELISA diagnostic test is the second antibody test product designed to identify novel coronavirus, while the first one is a rapid device for the qualitative detection of IgG and/or IgM antibodies.

The two test systems enable the company to work across the spectrum with facilities focusing on integrating automated antibody testing and rapid antibody testing, as well as considering to integrate an orthogonal testing algorithm for positive results to enhance positive predictive value.

Zeus’ test will help detect individuals with an adaptive immune response to novel coronavirus

ZEUS ELISA SARS-CoV-2 IgG Test System will allow identifying individuals with an adaptive immune response to novel coronavirus.

The company’s assay applies a dual antigen combination of recombinant S1 receptor binding domain (RBD) viral protein and recombinant nucleoprotein to improve the performance.

According to Zeus, the ELISA test follows the company’s universal ELISA assay protocol and showed 100% clinical sensitivity and 100% clinical specificity using PCR as the reference method.

The performance of ZEUS ELISA SARS-CoV-2 IgG test has been validated on the Dynex Technologies suite of instruments such as DS2, DSX and Agility.

The new test system also features the company’s patented SAVe Diluent, a component that changes colour when serum is added.

With more than 125 US FDA-cleared assays, Zeus Scientific offers in vitro diagnostic immunoassays for multiple infectious diseases.