Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07378514

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to provide written informed consent.
  • Willing to comply with study procedures.
  • The participant must present as one of the following cohorts (primary presenting condition):
  • 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)
  • Cohort C - Cardiovascular Cohort (participants presenting with symptoms indicative of heart failure or acute coronary syndrome)
  • Cohort D - Renal Cohort (participants presenting with symptoms indicative of renal disorders)
  • Cohort E - Oral Anticoagulation Cohort (participants with ongoing vitamin K antagonist therapy for at least four weeks)
  • Cohort F - Diabetes Cohort (participants with suspected pre-Diabetes or diagnosed with Diabetes Mellitus Type 1 or Type 2)
  • Cohort G - Lipid Cohort (participants presenting with symptoms indicative for Hypercholesterolemia )
  • Cohort H - Liver Cohort (participants with symptoms indicative of hepatic disorders).

Inclusion criteria

for Cohorts A, B, C, D, E, G, and H:

  • Participants ≥ 18 years of age

Inclusion criteria

for Cohort F (Diabetes Cohort):

  • Participants ≥ 16 years old

Exclusion criteria

  • 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.

Exclusion criteria

for Cohort E (Oral Anticoagulation Cohort):

  • 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)
  • The participant is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, experimental drug, or experimental device including either treatment or therapy.

Treatment and study plan

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

Primary outcomes

  1. Biomarker concentration

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zoe Pounce, PhD

CONTACT

[email protected]

+44 1786 533 206

Sponsors and collaborators

Lead sponsor

LumiraDx UK Limited

Industry

Registry information

Official study title

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

Acronym: EVOLVE

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.