Molecular Reagent Kit LumiraDx™ Real-time PCR SARS-CoV-2 / FLU A+B RNA STAR Complete For use with Thermocycler 96 Tests
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
Product Specifications
Description
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