COVID-19
SARS-CoV-2
Antigen Test

The LumiraDx SARS-CoV-2 Ag Test is a microfluidic immunofluorescence assay for direct and qualitative detection of nucleocapsid proteins in nasal and nasopharyngeal swab specimens from patients suspected of COVID-19. Used with the LumiraDx Instrument the Test delivers rapid results at the point-of-care.

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.

  • Easy to implement in point-of-care settings
  • Clinical performance
    • 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.

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.

100% positive agreement was achieved with samples with cycle threshold values (ct) < 33 (Roche Cobas 6800 SARS-CoV-2 reference method)

Swab method performance 12 days post RT-PCR test

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. Available in the USA under Emergency Use Authorization for SARS-COV-2 assays.