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FDA Grants Emergency Use Authorization for University of Illinois Coronavirus PCR Test

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for an RT-PCR-based SARS-CoV-2 test developed by the University of Illinois.

The university's CovidShield assay is designed to detect the ORF1ab, N, and S genes of the virus in saliva samples collected in the presence of a trained observer. The test uses primers and probes from Thermo Fisher Scientific's FDA-authorized TaqPath COVID-19 Combo Kit and can run on that company's QuantStudio 3, QuantStudio 7 Flex, and QuantStudio 7 Pro instruments. 

CovidShield may be used by CLIA-certified labs designated by the University of Illinois, including the University of Illinois Veterinary Diagnostic Laboratory, according to the FDA.