LumiraDx Fast Lab Solutions is a dedicated LumiraDx business unit that supports high-complexity laboratory testing by utilizing its innovative qSTAR nucleic acid amplification technology in an accessible high-throughput format to leverage current molecular laboratory operations.

 

Our Fast Lab Solutions provide laboratories high-quality molecular diagnostic testing options that are fast, cost-effective, and accurate.

 

 

qSTAR Technology

Innovative Fusion of Speed and Accuracy

qSTAR (Selective Temperature Amplification Reaction) is transforming molecular diagnostics by providing fast, accurate, and high throughput testing solutions with rapid amplification within 20 minutes or less on open RT-PCR instrumentation.

RNA STAR Complete

SARS-CoV-2 RNA STAR Complete offers high sensitivity, high throughput, and fast direct amplification within 20 minutes to support core lab, school, workplace, travel, and event testing.
  • As of November 1, 2021 can detect all known circulating variants including Omicron and Delta
  • Authorized for the screening of asymptomatic individuals
  • Validated on multiple open 96- and 384-well RT-PCR instruments
Full test details

RNA STAR

SARS-CoV-2 RNA STAR is a rapid nucleic acid amplification assay.

LumiraDx SARS-CoV-2 RNA STAR qualitatively detects RNA from SARS-CoV-2 in upper respiratory specimens. LumiraDx SARS-CoV-2 RNA STAR reagents are designed to reduce the amplification steps of the PCR process.

Full test details

SARS-CoV-2 RNA STAR and SARS-CoV-2 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. The emergency use of SARS-CoV-2 RNA STAR and SARS-CoV-2 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 or the SARS-CoV-2 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