NEW YORK — The US Food and Drug Administration on Monday granted Emergency Use Authorization for a PCR-based SARS-CoV-2 test developed by laboratory services provider LifeHope Labs.
The LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel, which is based on the US Centers for Disease Control and Prevention's CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel, is designed to detect two regions in the SARS-CoV-2 nucleocapsid gene in upper respiratory and bronchoalveolar lavage specimens.
The test runs on Thermo Fisher Scientific's Applied Biosystems QuantStudio 5 instrument and may only be performed by Sandy Springs, Georgia-based LifeHope, according to the FDA.