A Performance Evaluation of The LumiraDX Point of Care D-DIMER Assay

Venous thromboembolism (VTE) encompasses deep vein thrombosis (DVT) and pulmonary embolism (PE). It is the third most frequent cardiovascular disease with an overall annual incidence of 100–200 per 100 000 inhabitants. VTE may be lethal in the acute phase or lead to chronic disease and disability, but it is also often preventable. This study aims to assess the precision and accuracy of the LumiraDx point of Care (POC) D Dimer test when used in patients presenting with symptoms of VTE which can deliver a quantitative result in under 10 minutes from a finger stick blood sample. Current tests require venous blood samples or are laboratory tests that take 30-60+ minutes to return a result to the attending clinician.

Primary Objective: To determine the performance of the LumiraDx POC D Dimer assay when compared to the VIDAS D-Dimer Exclusion reference method in patients with suspected VTE.

Secondary objectives:

1. Performance evaluation of the haematocrit measurement by the LumiraDx POC D Dimer test with Hemocue Hb 201 system.
2. Clinical performance of the LumiraDx POC D Dimer assay when used as an aid in the exclusion of DVT and PE.

Sample: Patients presenting to the Emergency department with symptoms of deep vein thrombosis or pulmonary embolism.

Trial design: Prospective observational (cohort) Performance evaluation study

Target – 400