The LumiraDx SARS-CoV-2 Ag Test is a microfluidic immunofluorescence assay for the direct and qualitative detection of nucleocapsid protein antigen in nasal or 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. 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.
Authorized for use in asymptomatic individuals without need for serial screening -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
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.
LumiraDx SARS-CoV-2 Ag Test has not been cleared or approved by FDA. The LumiraDx SARS-CoV-2 Ag test has been authorized by FDA under an EUA only for the detection of SARS-CoV-2 nucleocapsid protein. The test has not been authorized for use to detect any other viruses or pathogens. The test is authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or 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.
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