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FDA Issues EUAs for University of Alabama, HealthQuest Esoterics Coronavirus Tests

NEW YORK — The US Food and Drug Administration on Tuesday issued separate Emergency Use Authorizations (EUAs) for PCR-based SARS-CoV-2 tests developed by the University of Alabama at Birmingham (UAB) and clinical laboratory HealthQuest Esoterics.

UAB's FRL SARS-CoV-2 Test is based on the US Centers for Disease Control and Prevention's CDC 2019-nCoV Real-Time RT-PCR but is designed to detect only one target in the virus' N gene. It uses nasopharyngeal, oropharyngeal, nasal, midturbinate nasal, and anterior nasal swabs, as well as in nasopharyngeal wash/aspirate, nasal aspirate, and bronchoalveolar lavage specimens.

UAB's test also differs from the CDC's assay in that it uses Omega Bio-Tek's EZNA Viral RNA Kit for nucleic acid isolation and runs on Thermo Fisher Scientific's Applied Biosystems QuantStudio 5 Real-Time PCR system. It may only be performed by the UAB Fungal Reference Lab.

HealthQuest Esoterics' TaqPath SARS-CoV-2 Assay uses primers and probes from Thermo Fisher's TaqPath COVID-19 Combo Kit, which received a second expanded EUA in May, that target viral genomic regions encoding Orf-1ab, the N protein, and the S protein. It is designed to detect the targets in nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate nasal swabs, as well as nasopharyngeal wash/aspirate or nasal aspirates and bronchoalveolar lavage specimens.

HealthQuest's assay is designed for use with the Applied Biosystems QuantStudio 12K Flex Real-Time PCR system and may only be performed by the company.

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