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TBG Biotechnology, U of Arizona Coronavirus Antibody Tests Get FDA Emergency Use Authorizations

NEW YORK — The US Food and Drug Administration on Monday granted separate Emergency Use Authorizations for SARS-CoV-2 antibody tests developed by TBG Biotechnology and the University of Arizona.

The TBG SARS-CoV-2 IgG/IgM Rapid Test Kit is a lateral flow immunoassay designed to detect and differentiate immunoglobulin G and M antibodies against the virus in serum and plasma. Results are provided in 15 to 20 minutes, according to Melbourne, Australia-based TBG.

The test may be used by any lab certified to perform moderate- or high-complexity tests, the FDA said.

In June, TBG received EUA from the FDA for its RT-PCR-based ExProbe SARS-CoV-2 Testing Kit. 

The University of Arizona's COVID-19 ELISA pan-Ig Antibody Test Assay is an ELISA-based test designed to detect total antibodies against SARS-CoV-2 in serum, including immunoglobulin A, G, and M. It may be performed only at the University of Arizona Genetics Core for Clinical Services.