Innovative Fusion of Speed and Accuracy

High-sensitivity, high-throughput, and fast molecular
diagnostics on open RT-PCR instruments.

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.
  • Based on in silico analysis we confirm detection of all known circulating variants including Omicron, Omicron B.2 and Delta
  • Authorized for the screening of asymptomatic individuals
  • Validated on multiple open 96- and 384-well RT-PCR instruments

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.

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