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FDA Issues Emergency Use Authorizations for Gravity Diagnostics, Aspirus, CSI Coronavirus Tests

NEW YORK — The US Food and Drug Administration on Monday granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Gravity Diagnostics, Aspirus, and CSI Laboratories.

Gravity's COVID-19 Assay is designed to detect two regions in the SARS-CoV-2 nucleocapsid (N) gene in nasal, nasopharyngeal, and oropharyngeal swabs and bronchoalveolar lavage. It uses Thermo Fisher Scientific's King Fisher Flex instrument and Magmax Pathogen Kit RNA/DNA for nucleic acid extraction, and runs on Thermo Fisher's Applied Biosystems QuantStudio 7 Flex instrument with software version 1.3 or the QuantStudio12 Flex instrument with software version 1.2.2.

The Aspirus SARS-CoV-2 rRT-PCR Assay is designed to detect regions in the SARS-CoV-2 N gene in upper respiratory specimens including nasal swabs and bronchoalveolar lavage. It uses Becton Dickinson's BD Max nucleic acid extraction and RT-PCR instrument.

CSI's SARS-CoV-2 RT-PCR Test is designed to detect regions in the SARS-CoV-2 N gene in upper respiratory specimens and bronchoalveolar lavage. Viral RNA is isolated using Eppendorf's EPMotion liquid handler and Omega BioTek's Mag-Bind Viral DNA/RNA 96 Kit, and the test runs on the Applied Biosystem QuantStudio 7 instrument with software version 1.3.

All three tests may only be performed at their developers' CLIA-certified labs.