SARS-CoV-2
Ag - WHO

The LumiraDx SARS-CoV-2 Ag Test is a microfluidic immunofluorescence assay which delivers connected, lab comparable results in 12 minutes.

Now included on the World Health Organization’s Emergency Use Listing (EUL)

  • First microfluidic assay to meet the criteria
  • Added based on an essential set of quality, safety, efficacy and performance data

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.

  • Sample type: Nasal
  • Time to result: 12 minutes
  • Storage: No refrigeration storage required, temperature storage (2-30°C)
  • LoD: 32TCID50/ml
  • Variant detection: Comparable sensitivity across variants*

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.

Clinical sensitivity compared to RT-PCR up to 12 days since onset of symptoms

PPA97.6%
NPA96.6%

*Refer to SARS-CoV-2 Variants technical bulletin on LumiraDx.com for further details

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COMPLIANCE DOCUMENTS

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.

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