Cobas® Lumira Collection of Venous and Capillary Blood Samples for the Research, Optimization and Calibration of New Diagnostic Devices

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorLumiraDx UK Limited

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

This trial does not accept healthy volunteers

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 population

UK-based adults presenting to a study site and meeting the eligibility criteria. There are no demographic requirements for this study

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

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

    Diagnostic test

    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.

Group A: Blood clot1 intervention
Group B: Infection/Inflammation1 intervention
Group C: Heart disease1 intervention
Group D: Kidney disease1 intervention
Group E: Blood thinners1 intervention
Group F: Diabetes1 intervention
Group G: High cholesterol1 intervention
Group H: Liver disease1 intervention

Trial outcomes

Primary outcomes

1

Biomarker concentration

Blood samples will be used to take a quantitative baseline measurement of 1 or more biomarkers associated with the following health conditions: * Thromboembolism * Infection/Inflammation * Cardiovascular disease * Kidney disease * Vitamin K antagonist therapy * Diabetes * Hypercholesterolemia * Liver disease. Measurements are used for research, development and calibration of point-of-care diagnostic tests, and may compare results between different test methods. There is no statistical analysis planned on these measurements.

Time frame
Baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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