The LumiraDx SARS-CoV-2 Ab Test is a microfluidic immunofluorescence assay for qualitative detection of total antibodies to SARS-CoV-2 in human whole blood (capillary fingerstick or venous), plasma or serum for indication of recent or prior infection. Used with the LumiraDx Platform the Test delivers rapid results at the point of care.
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.
In clinical studies, fingerstick samples showed 100% positive agreement and 100% negative agreement when collected more than 8 days post RT-PCR.
In clinical studies, plasma samples demonstrated an overall 97.2% positive agreement and 100% negative agreement when compared to RT-PCR.
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.