Pulmonary Embolism Clinical Trial
Official title:
A Performance Evaluation of the LumiraDx Point Of Care D-dimer Assay
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.
This is a performance evaluation study designed to assess the precision and accuracy of the LumiraDx Point of Care (POC) D-Dimer test when used in patients presenting with symptoms of Venous thromboembolism (VTE), which mainly comprises deep vein thrombosis (DVT) or pulmonary embolism (PE). The LumiraDx POC D-Dimer test is a quantitative immunoassay providing results in under 10 minutes. The accuracy of the LumiraDx POC D-Dimer test will be assessed using capillary whole blood, venous blood, and plasma samples, by comparison to the D-Dimer results obtained from the same individuals as analysed by trained laboratory professionals using a reference device. The results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test in the European Union (EU) and other relevant geographies. Adult males and females presenting to the study sites with symptoms of VTE will be included in the study. Approximately 1000 subjects will be recruited in total. An initial analysis will be completed on the first 200 patients to determine accuracy of the LumiraDx D-Dimer test versus the reference method. The study will continue until 1000 patients are recruited and with a minimum of 120 confirmed VTE events, in order to complete retrospective analysis using the LumiraDx D-Dimer cut-off for exclusion of VTE. Once consent is obtained, blood tube samples will be drawn and finger-stick samples of capillary blood will be taken from the subject, these will be applied directly to unique test strips for immediate measurement of D-Dimer on the LumiraDx POC D-Dimer test. The D-Dimer results obtained via the LumiraDx D-Dimer test will be used in a set of comparative analyses designed to determine the performance characteristics of the test. This study is an observational, cross-sectional design. As an observational study of an investigative device, results obtained during the course of the study will not inform or alter patient management or treatment decisions in any way. ;
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