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A Performance Evaluation of the LumiraDx Point Of Care D-dimer Assay
Sponsor: LumiraDx UK Limited
Summary
In patients with symptoms of Venous Thromboembolism (VTE) (mainly deep vein thrombosis (DVT) or pulmonary embolism (PE)), the study will evaluate the agreement between the D-Dimer measurements from the LumiraDx POC D-Dimer assay and a reference method, as an aid in diagnosis, assessment and exclusion of DVT and PE.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
679
Start Date
2021-03-18
Completion Date
2022-09-28
Last Updated
2026-06-11
Healthy Volunteers
No
Interventions
Venepuncture
Venous blood draw
Fingerstick
Capillary blood draw
Locations (13)
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg, Germany
Addenbrookes Hospital
Cambridge, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Epsom and St Helier Hospitals
Epsom, United Kingdom
Glsagow Royal Infirmary
Glasgow, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
St Johns Hospital
Livingston, United Kingdom
Homerton University Hospital NHS Foundation Trust
London, United Kingdom
Royal London Hospital
London, United Kingdom
St Georges Hospital
London, United Kingdom
University College Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
South Warwickshire Foundation Trust
Warwick, United Kingdom