FDA grants EUA to ZEUS Scientific’s SARS-CoV-2 total antibody test 

May 18, 2021 (Last Updated May 18th, 2021 09:49)

ZEUS Scientific’s total antibody test for SARS-CoV-2 detection from human serum and plasma receives FDA EUA.

FDA grants EUA to ZEUS Scientific’s SARS-CoV-2 total antibody test 
The ELISA test showed a positive agreement of 96%, negative agreement of 98.9% and 100% specificity Credit: Frauke Riether from Pixabay.

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to ZEUS Scientific’s in vitro ELISA diagnostic test to qualitatively identify total antibodies (IgG/IgM/IgA) to SARS-CoV-2 in human serum and plasma.

The ZEUS ELISA SARS-CoV-2 Total Antibody Test System is indicated for detecting people with an adaptive immune response to the Covid-19 virus, signifying recent or previous infection.

It uses a combination of two antigens, recombinant S1 receptor binding domain viral protein and recombinant nucleoprotein.

The test checks for a total antibody response to the Nucleocapsid as well as Spike SARS-CoV-2 antigens and can act as a serological screening assay or first-tier test in an orthogonal testing algorithm.

As compared to the FDA-authorised RT-PCR tests, this ELISA test showed a positive agreement of 96%, negative agreement of 98.9% and 100% specificity.

This new assay uses ZEUS’ universal ELISA assay protocol, which is said to provide greater flexibility with incubation times permitting effective automation programming on open pipetting systems.

The total antibody test is authorised for use manually or on the Dynex Agility, Dynex DSX or Dynex DS2 Automated ELISA Systems.

In a separate development, Summa Equity entered a definitive agreement to sell HyTest, an antibody and antigen products developer, to medical technology company Mindray for a total consideration of $665m (€545m).

Acquired by Summa Equity in 2018, HyTest’s products span more than 20 disease areas and offer antibodies and antigens for in vitro diagnostic (IVD) tests. These IVD tests are used on more than 300 million people across the globe annually.

Mindray president Hao Wu said: “HyTest, a world-renowned, top-notch supplier of upstream IVD raw materials, has established friendship and mutual trust with Mindray during more than ten years of cooperation.

“Upon completion of the transaction, we expect HyTest to invest additional resources to continuous development of technologies and products, as well as advance technological innovation and academic exploration.”

The deal is anticipated to conclude in the second half of the year.