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.