EMBOL 1

• Research type

  Research Study

• Full title

  A Performance Evaluation Of The LumiraDx Point Of Care D Dimer Assay

• IRAS ID

  247463

• Contact name

  Richard Body

• Contact email

  richard.body@manchester.ac.uk

• Clinicaltrials.gov Identifier

  NCT04737954

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  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 consists of the LumiraDx Platform, an in vitro diagnostic instrument, used with single use LumiraDx D Dimer Test Strips. The intended use of the test is as an aid in the diagnosis, assessment and exclusion of VTE when used in the laboratory or in a point of care setting.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  19/NW/0070

• Date of REC Opinion

  28 Feb 2019

• REC opinion

  Favourable Opinion