LumiraDx's SARS-CoV-2 RNA STAR Assay Secures FDA Emergency Use Authorization

LumiraDx (London, UK) has secured Emergency Use Authorization from the US Food and Drug Administration (FDA) for its SARS-CoV-2 RNA STAR assay.

The LumiraDx SARS-CoV-2 RNA STAR is a molecular test kit which uses a non-isothermal nucleic acid amplification qSTAR (Selective Temperature Amplification Reaction) method intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal and oropharyngeal swabs) and bronchoalveolar lavage specimens collected from individuals suspected of COVID-19 by their healthcare provider.

It is used for the qualitative detection of RNA from SARS-CoV-2 (COVID-19). The patient sample is collected and purified through standard automated or manual extraction processes. The sample is then added to the MasterMix where it is transcribed to cDNA. If the virus is present in the sample, it will be amplified by the qSTAR technology in approximately 12 minutes. Following the rapid amplification of the virus, the target is specifically detected with molecular beacons to which the results are reported out as positive or negative.

Nucleic acid extraction is performed using Qiagen's QIAsymphony DSP Virus/Pathogen Kit and automated QIAsymphony SP instrument or manually using either Thermo Fisher's MagMax Viral/Pathogen Nucleic Acid Isolation Kit or Qiagen's QIAamp Viral RNA Mini Kit. The test can run on a variety of instruments including Roche's LightCycler 480 II, Thermo Fisher's Applied Biosystems 7500 Fast Dx and QuantStudio 5, and Agilent's AriaMx and Stratagene Mx3005P. The LumiraDx SARS-CoV-2 RNA STAR assay has been validated from common upper respiratory tract specimens in Universal Transport Medium.

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