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 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 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 | LumiraDx | PPA |
|---|---|---|---|
| 0 | 6 | 6 | 100.0% |
| 1 | 12 | 12 | 100.0% |
| 2 | 28 | 28 | 100.0% |
| 3 | 37 | 37 | 100.0% |
| 4 | 55 | 54 | 98.2% |
| 5 | 61 | 60 | 98.4% |
| 6 | 67 | 66 | 98.5% |
| 7 | 73 | 72 | 98.6% |
| 8 | 75 | 74 | 98.7% |
| 10 | 77 | 76 | 98.7% |
| 11 | 80 | 79 | 98.8% |
| 12 | 83 | 81 | 97.6% |
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.
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.