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FDA Grants Emergency Use Authorizations for Wadsworth Center, Altru Dx Coronavirus Tests

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.

Altru Diagnostics' SARS-CoV-2 Test uses Thermo Fisher Scientific's TaqMan 2019-nCoV Assay Kit v1 and is designed to detect the Orf1ab, N gene, and S gene regions of the SARS-CoV-2 RNA genome in upper respiratory specimens including nasal swabs. Nucleic acid extraction is performed using Thermo Fisher's KingFisher Flex Purification System with Applied Biosystems MagMax Viral/Pathogen Nucleic Acid Isolation Kit, and the test runs on Thermo Fisher's QuantStudio 12K Flex RT-PCR system with the QuantStudio 12K Flex Software V.1.2.2.

Use of the test is limited to Houston, Texas-based Altru Diagnostics.