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 pool test demonstrated 100% positive agreement and 96.6% negative agreement when compared to testing individual swabs on the LumiraDx SARS-COV-2 Ag Test, thereby ensuring high sensitivity is maintained while reducing overall testing times, costs and operators required for testing.
|Measure||Estimate||95 % Wilson Score CI|
|PPA||100.0 %||88.6 %||100.0 %|
|NPA||96.6 %||82.8 %||99.4 %|
|PPV||96.8 %||83.8 %||99.4 %|
|NPV||100.0 %||87.9 %||100.0 %|
LOD results when conducted with SARS-CoV-2 Pool Test (1 positive swab and 4 negative swabs) were comparable to LOD studies run with the SARS-CoV-2 Ag Test, which has an LOD of 32 TCID50/mL
Test performance in asymptomatic population
The performance of the LumiraDx SARS-CoV-2 Ag Test was established with direct nasal and nasopharyngeal swabs prospectively collected from asymptomatic individuals during the 2020 pandemic.
|Grouping||Nasal swabs||NP swabs|
|n||PPA||95% CI||NPA||95% CI||n||PPA||95% CI||NPA||95% CI|
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. Not available in the USA.
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.