RNA STAR

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.

For more information about LumiraDx SARS-CoV-2 RNA STAR

RNA STAR IFU

RNA STAR Fact Sheet for Healthcare Providers

RNA STAR Fact Sheet for Patients

RNA STAR Product Insert

SDS

SARS-CoV-2 RNA STAR, SARS-CoV-2 RNA STAR Complete, SARS-CoV-2 & Flu A/B RNA STAR Complete have not been FDA cleared or approved but have been authorized by FDA for emergency use under an EUA for use by authorized laboratories. SARS-CoV-2 RNA STAR and SARS-CoV-2 RNA STAR Complete have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. SARS-CoV-2 & Flu A/B has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens. The emergency use of SARS-CoV-2 RNA STAR, SARS-CoV-2 RNA STAR Complete, SARS-CoV-2 & Flu A/B RNA STAR Complete is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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 declaration is terminated, or authorization is revoked sooner.

Users should refer to the LumiraDx SARS-CoV-2 RNA STAR, SARS-CoV-2 RNA STAR Complete, SARS-CoV-2 & Flu A/B RNA STAR Complete Instructions for Use posted on the FDA website for all IVD products used under Emergency Use Authorization.

In Vitro Diagnostics EUAs - Molecular Diagnostic Tests for SARS-CoV-2 | FDA