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Zeus Scientific Gets FDA Emergency Use Authorization for SARS-CoV-2 Total Antibody Test

NEW YORK — The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for Zeus Scientific's ELISA SARS-CoV-2 Total Antibody Test System.

The assay is designed for the detection of total antibodies against SARS-CoV-2 in serum and plasma. It can be run manually or by using Dynex Technologies' Dynex Agility, DSX, or DS2 automated ELISA systems.

The assay is authorized for use by labs CLIA-certified to perform moderate- or high-complexity tests, according to the FDA.

In October, Branchburg, New Jersey-based Zeus received FDA EUA for a test designed to detect immunoglobulin G against SARS-CoV-2.