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.

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.

LumiraDx SARS-CoV-2 RNA STAR is available in the US under FDA Emergency Use Authorization. The test has not been FDA cleared or approved. LumiraDx SARS-CoV-2 RNA STAR has been authorized by FDA under an EUA for use by authorized laboratories. The test is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

The test is only authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 

Users should refer to the LumiraDx SARS-CoV-2 RNA STAR Instructions for Use posted on the FDA website for all IVD products used under Emergency Use Authorization, http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm.