The LumiraDx SARS-CoV-2 Ag Test is a microfluidic immunofluorescence assay for the direct and qualitative detection of nucleocapsid protein antigen in nasal and nasopharyngeal swab specimens from individuals suspected of COVID-19 or asymptomatic individuals. Used with the LumiraDx Platform the test delivers rapid results at the point of care.
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
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.
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.
|PPA||NPA||PCR Cycle threshold <33|
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.
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.