About this trial

This study is a blood sample collection study, collecting venous and capillary blood samples from adult patients in the UK, with a range of health conditions. The purpose of this study is to collect blood samples to help develop, improve, and fine-tune new and existing diagnostic tests for the cobas® lumira instrument. This instrument is a diagnostic medical device with single-use test strips, that allows diagnostic testing right at the patient's side. The aim is to improve doctors' ability to monitor health conditions more quickly and easily.

Approximately 30,000 patients are expected to participate in this study, across multiple UK sites.

Eligibility criteria

Qualifiers

Willing and able to provide written informed consent.

Willing to comply with study procedures.

Cohort A - Embolism Cohort (participants presenting with symptoms indicative of thromboembolic events)

Cohort B - Infection or Inflammation Cohort (participants presenting with symptoms indicative of infection or inflammatory disorders)

Disqualifiers

Subjects deemed inappropriate for the study by the Principal Investigator.

Participants who have previously been enrolled in the EVOLVE study in the past 60 days.

Subjects who are currently taking non-vitamin K antagonist oral anticoagulants (NOACs) including but not limited to apixaban, dabigatran etexilate, edoxaban and rivaroxaban.

Subjects who have anti-phospholipid antibody syndrome (APS)

Trial design

Treatments tested in this trial

  • Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests

Treatment groups

30,000 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Locations

This trial has no locations

Sponsors and collaborators

LumiraDx UK Limited

Lead sponsor