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) following a Wells score classification.
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:
|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)|
A method comparison was performed using plasma samples from patients (n = 327, range = 60 - 4515 μg/L 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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