The LumiraDx SARS-CoV-2 Ab Test is designed to be used in community care settings to identify individuals with an adaptive immune response to COVID-19, indicating recent or prior infection.
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 collection with a fingerstick lancet followed by step-by-step guidance of the Instrument to report a patient result in 11 minutes from sample application.
Fingerstick sample performance
In clinical studies, fingerstick samples showed 100% positive agreement and 100% negative agreement when collected more than 8 days post RT-PCR.
|Positive agreement||Negative agreement|
|Direct fingerstick||100% (62/62)||100% (54/54)|
|Fingerstick via transfer tube||100% (62/62)||100% (56/56)|
Plasma sample performance
In clinical studies, plasma samples demonstrated an overall 97.2% positive agreement and 100% negative agreement when compared to RT-PCR.
|Days from RT-PCR to blood collection||Number of sample||Sensitivity RT-PCR comparator|
|≤ 6 days||13||84.6 %|
|7-13 days||7||100 %|
|14-20 days||6||100 %|
|≥ 21 days||46||100 %|
|Total||72||97.2 % (90.4 % - 99.2 %)|
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.
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.