Molecular Reagent LumiraDx™ SARS-CoV-2, Influenza A / B RNA STAR Complete For Thermocycler 96 Tests

Features

• The LumiraDX SARS-CoV-2 and FLU A+B RNA STAR Complete is for Emergency Use Authorization (EUA) Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2#individual-molecular LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete is a rapid
• non-isothermal nucleic acid amplification qSTAR (Selective Temperature Amplification Reaction) in vitro diagnostic test intended for the simultaneous qualitative detection and differentiation of RNA from the SARS-CoV-2
• Influenza A
• and/or Influenza B viruses in nasopharyngeal swabs from individuals with signs and symptoms of respiratory tract infection consistent with COVID-19 Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
• 42 USC. §263a that meet requirements to perform high complexity tests Laboratories within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities Positive results are indicative of the presence of SARS-CoV-2
• Influenza A
• and/or Influenza B RNA but do not rule out bacterial infection or co-infection with other pathogens not detected by the test; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status Negative results do not preclude SARS-CoV-2
• Influenza A
• and/or Influenza B infection and should not be used as the sole basis for patient management decisions; negative results must be combined with clinical observations
• patient history
• and epidemiological information LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures Materials provided: 250 µL postive control media
• 1.5 mL negative control media
• 1 mL salt mix
• 500 µL extraction buffer
• 400 µL internal control and primer mix
• 2 mL master mix Options for 96-Well Instruments (not provided): Applied Biosystems QuantStudioTM 5
• Applied Biosystems QuantStudio 7 Flex
• Bio-Rad CFX Opus 96 Real-Time PCR Instrument