Zeus Scientific Seeks FDA EUA Status For SARS-CoV-2 Total Antibody Test

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

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

Zeus in vitro ELISA diagnostic test is the third SARS-CoV-2 antibody test system designed to detect novel coronavirus and the second ELISA assay to identify IgG antibodies.

ZEUS ELISA SARS-CoV-2 Total Antibody Test System will enable to detect individuals with an adaptive immune response to novel coronavirus.

The in vitro ELISA diagnostic test’s performance has been validated on Dynex Technologies suite of instruments

The total antibody system applies a dual antigen combination of recombinant S1 receptor-binding domain (RBD) viral protein and recombinant nucleoprotein to enhance the performance.

According to the company, the ZEUS ELISA SARS-CoV-2 Total Antibody Test System, which combines both PCR and serology as clinical truth, has delivered 98.8% sensitivity and 99.1% specificity.

The performance of SARS-CoV-2 Total Antibody Test System has been validated on the Dynex Technologies suite of instruments such as DS2, DSX, and Agility.

The new test system is also comprised of Zeus patented SAVe Diluent, a component designed to change colour when serum is added. – NS Medical Devices