D-Dimer Test

The LumiraDx D-Dimer Test is an easy to use fluorescence immunoassay designed to rapidly quantify D-Dimer levels in human whole blood and plasma at the point of care. It is the first quantitative micro-fluidic immunoassay of its kind, providing a precise and accurate D-Dimer result from a single direct fingerstick blood sample, in only 6 minutes.

The LumiraDx D-Dimer Test is an in vitro diagnostic test for the quantitative determination of D-Dimer in human whole blood (capillary fingerstick and sodium citrated venous) and sodium citrated plasma samples. The Test can be used as an aid in the assessment and diagnosis of patients with suspected venous thromboembolism (VTE) such as deep vein thrombosis (DVT) and pulmonary embolism (PE).

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).

  • Fast, accurate, quantitative results in just 6 minutes
  • Direct fingerstick sampling
  • Only 15µL sample volume required
  • Room temperature Test Strip storage
  • Precision:  ≤11.1% CV

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.

D-Dimer test workflow

Test performance

Method comparison

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.

Precision

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.

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.