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.
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 – 100 (TBC)
Honorary Professor of Emergency Medicine & Clinical Director of the Emergency Department
Diagnostics devices play an important part in the clinical assessment of a patient’s health and treatment. The purpose of the study is the evaluation of a new diagnostic platform developed by LumiraDx. The evaluation is focused around various biomarkers useful in the emergency settings.
Collection of venous and capillary blood samples for the evaluation of new diagnostic devices for cardiovascular conditions