COVID-19 rapid test Lyra

proteinSARS-COV-2coronavirus

The Lyra 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 authorized testing consists of nucleic acid extraction on the bioMerieux NucliSENS® easyMAG® system or EMAG system, followed by RT-PCR on one of six thermocyclers: Applied Biosystems® 7500 Fast Dx, Applied Biosystems 7500 Standard, QuantStudioTM Real-Time PCR Instrument, Roche LightCycler® 480, BioRad CFX96 Touch, or Qiagen Rotor-Gene Q. One-step reagent set-up Rehydration solution is simply added to the lyophilized Master Mix Speed Results in less than 75 minutes after extraction 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 vials of 12x8 Master Mix, Rehydration Solution and liquid Process Controls Sample type Nasal, Nasopharyngeal (NP) or Oropharyngeal (OP) swab Time to results Less than 75 minutes after extraction Reagent and Controls storage conditions 2°C to 8°C Sample volume needed for extraction 180 µL The Lyra 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.