SARS-CoV-2
Antigen Test

The LumiraDx SARS-CoV-2 Ag Test is a rapid microfluidic immunofluorescence assay for use with the LumiraDx Platform intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from anterior nasal swab and nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

Test benefits

The use of a LumiraDx SARS-CoV-2 Ag Test on the LumiraDx Instruments will enable the physician to verify infection quickly, begin proper treatment and to initiate isolation precautions helping prevent further spread of infection.

Rapidly identify potentially contagious spreaders on the spot, reducing the risk of a local outbreak.

  • Easy to implement in point of care settings
  • Clinical performance in symptomatic individuals  
    • 97.6% positive percent agreement
    • 96.6% negative percent agreement
  • Analytical performance with a limit of detection of 32 TCID50/mL
  • RT-PCR comparable results within 12 days of onset of symptoms

Test workflow

The Instrument and Test Strips are integrated with several quality control checks to ensure the Instrument and Test are functioning correctly for every test run.

The workflow process is comprised of a simple sample prep along with step-by-step guidance of the Instrument to report a patient result in under 12 minutes from sample application.

The LumiraDx SARS-CoV-2 Ag Test workflow process is comprised of a simple sample prep along with step-by-step guidance of the Instrument to report a patient result

Test performance

In clinical studies, the LumiraDx SARS-CoV-2 antigen test demonstrated 97.6% positive agreement versus RT-PCR in patients tested within 12 days of the onset of symptoms, to enable the physician to verify infection quickly, begin proper treatment and to initiate isolation precautions helping prevent further spread of infection.

Days of
symptom onset
RT-PCR
comparator
LumiraDxPPA
066100.0%
11212100.0%
22828100.0%
33737100.0%
4555498.2%
5616098.4%
6676698.5%
7737298.6%
8757498.7%
10777698.7%
11807998.8%
12838197.6%

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.

Not all products are available in all countries and regions. Please check with your local LumiraDx sales representative or distributor for availability in specific markets.

BetterHealthExperiencesOutcomes

Supporting healthier lives, for individuals, communities and wider society

Enabling responsive, personal relationships between patients and care teams.

Controlling and reducing costs to help ease pressure on healthcare budgets.

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