FDA Emergency Use Authorization

The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the in vitro qualitative detection of human coronavirus SARS-CoV-2 from viral RNA extracted from nasal, nasopharyngeal (NP) or oropharyngeal (OP) swab specimens from patients with signs and symptoms of COVID-19. The Assay targets the non-structural Polyprotein (pp1ab) of the SARS-CoV-2 virus.

The Lyra Direct SARS-CoV-2 Assay has one-step reagent set-up and a three-step sample prep. Test results are available in less than 70 minutes. Lyra Direct SARS-CoV-2 Assay is a quality real-time PCR available for use on Applied Biosystems^® 7500 Fast Dx, Applied Biosystems 7500 Standard, Roche LightCycler^® 480 Instrument II, Roche cobas^® z 480, Qiagen Rotor-Gene^® Q, Bio-Rad CFX96 Touch™, Thermo Fisher QuantStudio™ 7 Pro.

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