COVID-19 rapid test Lyra Direct

proteinSARS-COV-2coronavirus

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. Features & Benefits One-step reagent set-up Rehydration solution is simply added to the lyophilized Master Mix Easy training Simplified and uniform workflow with standard pipetting volumes Refrigerated storage No freezer needed. 2°C to 8°C storage Flexible 96-test format Kit includes Process Buffer, 12x8 Master Mix, Rehydration Solution and liquid Positive and Negative Controls Reagent and Controls storage conditions 2°C to 8°C Product Documentation The Lyra Direct SARS-CoV-2 Assay has not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.