NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations (EUA) for SARS-CoV-2 assays developed by the New York State Department of Health's Wadsworth Center and Altru Diagnostics.
Wadsworth's New York SARS-CoV Microsphere Immunoassay for Antibody Detection is designed to detect human immunoglobulin G, immunoglobulin M, and immunoglobulin A antibodies against SARs-CoV-2 in serum. It runs on the Luminex FlexMap dual laser cytometer and is only authorized for use by Wadsworth.