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.
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,