lumira

LumiraDx SARS-CoV-2 Ag Test

An easy to use, fast microfluidic immunofluorescence assay designed to rapidly detect nucleocapsid protein antigen in anterior nasal and nasopharyngeal swab specimens. Used with the LumiraDx Platform, the LumiraDx SARS-CoV-2 Ag test provides actionable, lab-comparable results in just 12 minutes.

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Qualitative SARS-CoV-2 Ag test

The LumiraDx SARS-CoV-2 Ag test is an automated rapid microfluidic immunofluorescence assay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 Ag directly from anterior nasal swab and nasopharyngeal swab samples collected from individuals suspected of COVID-19 or from asymptomatic individuals.

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Near-patient testing

As an automated in vitro diagnostic test, it is made for near-patient testing with the LumiraDx Instrument.

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Purpose

The test can be used as an aid in the diagnosis of SARS-CoV-2 infection by detection of SARS‑CoV‑2 antigen.

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Verify COVID-19 quickly

Identify potentially infected and contagious spreaders quickly. Actionable and lab-comparable results for patients suspected of COVID-19.

  • Sample types: anterior nasal and nasopharyngeal swab
  • Anterior nasal swabs (symptomatic)
    • 97.6% PPA versus RT-PCR
    • 96.6% NPA versus RT-PCR
  • Time to result: 12 minutes
  • Storage at room temperature (2°C to 30°C)
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Acceptable swabs

The following swabs have been validated for use with the LumiraDx SARS-CoV-2 Ag test:

Anterior nasal:

  • Copan FLOQSwabs® 502CS01 Regular Flocked Swab with 80mm Breakpoint
  • Copan eSwab (Supplier Product Code: 490CE.A)
  • Copan FLOQSwabs® 552C Regular Flocked Swab with 80mm Breakpoint
  • Copan FLOQSwabs® 519CS01 Regular Flocked Swab with 100mm Breakpoint
  • Puritan HydraFlockTM Sterile Standard Flock Swab (Supplier Product Code: 25-3306-H)
  • Puritan HydraFlockTM Sterile Standard Flock Swab (Supplier Product Code: 25-3506-H)
  • Aspen SurgicalTM Polyester Swab (Supplier Product Code: 20200062)
  • SteriPackTM Sterile Polyester Spun Swab (Supplier Product Code: 60564)
  • mwe medical wire DrySwabTM Rayon Swab (Supplier Product Code: MW112)

Nasopharyngeal:

  • Copan FLOQSwabs® 501CS01 Minitip Flocked Swab with 80mm Breakpoint
  • Copan FLOQSwabs® 516CS01 Ultra Minitip Flocked Swab with 100mm Breakpoint
  • Copan FLOQSwabs® 518CS01 Minitip Flocked Swab with 100mm Breakpoint
  • Copan FLOQSwabs® 503CS01 Flexible Minitip Flocked Swab with 100mm Breakpoint
  • Copan FLOQSwabs® 534CS01 Flexible Minitip Flocked Swab with No Breakpoint
  • Copan FLOQSwabs® 551C Minitip Flocked Swab with 80mm Breakpoint
  • Copan FLOQSwabs® 553C Flexible Minitip Flocked Swab with 100mm Breakpoint
  • Copan FLOQSwabs® 518C Minitip Flocked Swab with 100mm Breakpoint

Only use the list of validated swabs with the LumiraDx SARS-CoV-2 Ag Test. Swabs from alternative suppliers are not validated for use with the LumiraDx SARS-CoV-2 Ag Test and must not be used.

Product documentation

This product has not been FDA cleared or approved but has been authorized by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product 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.