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 & Flu A/B test demonstrated up to 95.5%, 83.3% and 80.0% positive agreement versus RT-PCR for detection of SARS-COV-2, Flu A and Flu B respectively.
Clinical agreement compared to RT-PCR
|SARS-CoV-2||Flu A||Flu B|
|PPA||up to 95.5%*||83.3%||80.0%|
|NPA||up to 99.0%*||97.6%||94.9%|
*Based on 0-12 days since symptom onset data set - See LumiraDx SARS-CoV & Flu A/B Product Insert for more details
Not all products are available in all countries and regions.
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.