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FDA Reissues EUA for Broad Institute Coronavirus Test, Authorizes Immunoassay From Celltrion

NEW YORK — The US Food and Drug Administration last week reissued an Emergency Use Authorization for a PCR-based SARS-CoV-2 test from the Broad Institute to expand the types of samples it may use.

The agency also issued a new EUA for a SARS-CoV-2 immunoassay developed by Celltrion.

The Broad's CRSP SARS-CoV-2 Real-time Reverse Transcriptase-PCR Diagnostic Assay is designed to detect two regions in the SARS-CoV-2 N gene. In July, it received EUA from the FDA for use with upper respiratory and bronchoalveolar lavage specimens.

Under the reissued EUA, the test may also be used with dry nasal swabs collected by a healthcare provider, as well as dry nasal swabs self-collected without supervision using Broad's CRSP Self-Swab kit or Color's COVID-19 Self-Swab Collection Kit. Both self-collection kits have FDA EUA.

Celltrion's Sampinute COVID-19 Antigen MIA is a magnetic force-assisted electrochemical sandwich immunoassay designed to detect receptor binding domains in spike proteins from SARS-CoV-2. It uses nasopharyngeal swab specimens collected directly or collected using either Becton Dickinson's BD Universal Viral Transport Media, Copan Diagnostics' UTM-RT transport media, or a formulation of viral transport media described by the US Centers for Disease Control and Prevention.

The test runs on Celltrion's Sampinute Analyzer and may only be used by labs CLIA-certified to perform moderate- to high-complexity tests, according to South Korea-based Celltrion.

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