LumiraDx SARS-CoV-2 RNA STAR Complete is a rapid, non-isothermal nucleic acid amplification qSTAR method intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory swabs collected from individuals suspected of COVID-19 by their healthcare provider (HCP).
This test is also authorized for use with nasal swab specimens collected from any individual, including individuals without symptoms or other reasons to suspect COVID-19 when collected by a HCP or self-collected under the supervision of a HCP.
PPA: POSITIVE PERCENT AGREEMENT / NPA: NEGATIVE PERCENT AGREEMENT
CLINICAL / AT-HOME COLLECTION / SCHOOLS / WORKPLACE / EVENTS / TRAVEL
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.