Principles of the Procedure

  • LumiraDx received FDA Emergency Use Authorization (EUA) for its molecular test kit, LumiraDx SARS-CoV-2 RNA STAR, which reduces the amplification step of the PCR process from approximately one hour to 12 minutes.
  • This Fast Lab Solution utilizes LumiraDx’s innovative qSTAR amplification technology in an accessible high-throughput format in open molecular systems to improve efficiency and speed. 
  • qSTAR (quantitative Selective Temperature Amplification Reaction) uses a non-isothermal nucleic acid amplification technique that qualitatively detects RNA from SARS-CoV-2 (COVID-19).
  • This Test has been validated from common upper respiratory tract specimens in Universal Transport Medium (UTM).

Test Description

  • Patient sample is collected and purified through standard automated or manual extraction processes.
  • The sample is then added to the Reagent Mix where it is transcribed to cDNA.
  • If present in the sample, SARS-CoV-2 nucleic acids will be amplified by qSTAR technology and results will be reported in approximately 12 minutes.

LumiraDx SARS-CoV-2 RNA STAR reagents are for research use only and not for use in diagnostic procedures.

Not all products are available in all countries and regions. Please check with your local LumiraDx sales representative or distributor for availability in specific markets. Available in the US under FDA Emergency Use Authorization.