The LumiraDx D-Dimer Test is an in vitro diagnostic test for the quantitative determination of D-Dimer in human capillary and venous whole blood and plasma samples (Sodium Citrate). The LumiraDx D-Dimer Test Strips are intended for use with the LumiraDx Instrument. It is an automated in vitro diagnostic test for near-patient testing to aid in the assessment and diagnosis of patients with suspected venous thromboembolism (VTE) such as deep vein thrombosis (DVT) and pulmonary embolism (PE).
The test can be used in conjunction with a clinical pre-test probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in patients suspected of DVT or PE. The LumiraDx D-Dimer test is for Professional Use Only. For patients ≥18 years of age.
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.
A prospective clinical study was performed on 585 subjects where fresh samples (capillary blood, venous (blood citrated) and plasma (citrated)) were collected from patients presenting with symptoms of VTE (PE or DVT). Subjects also required an assessment with the Wells score and were classed as PTP ‘Likely’ or PTP ‘Unlikely’. Those with ‘Unlikely’ PTP categorization were further analysed using the LumiraDx D-Dimer test with 500 μg/L FEU (0.500 mg/L FEU) D-Dimer as cut-off. The corresponding sensitivity and negative predictive values (NPV) by sample matrix are listed below with corresponding Wilson Score 95% confidence intervals (CI).
|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.
|Within run precision|
|Within day precision|
|Between day precision|
*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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