D-Dimer Test
The LumiraDx D-Dimer test is an easy to use, fast microfluidic immunoassay designed to rapidly quantify D-Dimer levels in whole blood and plasma. It is the only direct fingerstick D-Dimer assay available today*, aiding healthcare professionals to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) in symptomatic patients with confidence** - in only 6 minutes.
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.
Test benefits
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).
- Precise and lab comparable results
- Time to results: 6 minutes
- Direct fingerstick sampling
- Clinical Cut-off: 500 µg/L Fibrinogen Equivalent Units (FEU), 0.500 mg/L FEU, 500 ng/mL FEU, 0.500 µg/mL
- Sample size: 15 µL
- Haematocrit correction for whole blood samples
- Room temperature storage (2–30°C)
Test workflow
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.
Test performance
Clinical Performance
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 a D-Dimer cut-off of 500 µg/L FEU, (0.5 mg/L FEU), (500 ng/mL FEU), (0.5 µg/mL FEU). The corresponding sensitivity and negative predictive values (NPV) by sample matrix are listed below:
| Estimate | Matrix | Patients with Suspected VTE |
|---|---|---|
| Unlikely PTP | ||
| 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) |
Method comparison
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.
| Method comparison | |
|---|---|
| Slope | 1.02 |
| Intercept | 21 |
| r | 0.92 |
Precision
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.
| D-Dimer concentration | Within run precision (% CV) | Within day precision (% CV) | Between day precision (% CV) | Total precision (% CV) | n |
|---|---|---|---|---|---|
| 291 µg/L FEU 0.291 mg/L FEU 291 ng/mL FEU 0.291 µg/mL FEU | 9.8 | 11.1 | 0.0 | 11.1 | 80 |
| 552 µg/L FEU 0.552 mg/L FEU 552 ng/mL FEU 0.552 µg/mL FEU | 9.4 | 9.4 | 2.5 | 9.7 | 80 |
| 1790 µg/L FEU 1.79 mg/L FEU 1790 ng/mL FEU 1.79 µg/mL FEU | 10.1 | 10.1 | 0.7 | 10.2 | 80 |
*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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