The LumiraDx D-Dimer Test improves efficiency in primary and secondary care settings by offering a rapid assessment of patients presenting with symptoms of deep vein thrombosis (DVT) and pulmonary embolism (PE).
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 6 minutes from sample application.
|Estimate||Matrix||Patients with Suspected VTE|
|Sensitivity % (95% CI)||Venous||100.0% (74.1%-100.0%; n = 378)|
|Capillary Direct||100.0% (72.2%-100.0%; n = 377)|
|Plasma||100.0% (74.1%-100.0%; n = 406)|
|NPV % (95% CI)||Venous||100.0% (98.3%-100.0%; n = 378)|
|Capillary Direct||100.0% (98.1%-100.0%; n = 377)|
|Plasma||100.0% (98.1%-100.0%; n = 406)|
The method comparison was performed using plasma samples from patients (n = 327, range = 60 - 4515 μg/L FEU). A comparison of 1767 D-Dimer measurements with the LumiraDx D-Dimer Test to the VIDAS Exclusion II D-Dimer assay yielded the following statistics: Slope = 1.02, Intercept = 21, r = 0.92.
A precision study was carried out in citrated venous plasma on a protocol based on CLSI EP5-A3. The study was carried out with 3 levels of D-Dimer, each was tested in 2 runs of 2 replicates per day, for twenty days.
*As stated at time of publication - 24th May 2022
**In conjunction with a clinical pre-test probability assessment model.
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.
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