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)|
|Direct Capillary||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)|
|Direct Capillary||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, (0.06 – 4.515 mg/L FEU), (60 – 4515 ng/mL FEU), (0.06 – 4.515 µg/mL FEU). 1767 D-Dimer measurements with the LumiraDx D-Dimer test and the VIDAS Exclusion II D-Dimer assay was completed.
A precision study was carried out in citrated venous plasma 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 - 10th March 2023
**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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