SARS-Cov-2

RNA STAR Complete

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.

  • Reliable and robust performance when compared to traditional RT-PCR tests
  • Increased throughput with 5:1 pooling on 96-well RT-PCR instruments
  • Direct amplification within 20 minutes drives lab's efficiency and productivity
  • Authorized with HealthPulse@home for at-home collection by any individual aged 16 years and older (self-collected), or 2 years and older (collected with adult assistance), including individuals without symptoms or other reasons to suspect COVID-19

Test Workflows

Performance

 

PPA: POSITIVE PERCENT AGREEMENT / NPA: NEGATIVE PERCENT AGREEMENT

Testing Programs

CLINICAL / AT-HOME COLLECTION / SCHOOLS / WORKPLACE / EVENTS / TRAVEL

The Fast Lab Network’s purpose is to strengthen the outreach of diagnostic testing through a network of laboratories that can respond to the ever-changing needs of infectious disease testing.

SARS-CoV-2 RNA STAR Complete has not been FDA cleared or approved but has been authorized by FDA for emergency use under an EUA for use by authorized laboratories. SARS-CoV-2 RNA STAR Complete has 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 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 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