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

NCT07378514 — Not yet recruiting, 30000 participants, LumiraDx UK Limited

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

Registry	NCT07378514, acronym EVOLVE
Status	Not yet recruiting
Study type	Observational
Enrollment	30000 (Estimated)
Sponsor	LumiraDx UK Limited (Industry)
Conditions	Blood Clots, Infection and Inflammatory Reaction, Heart Disease, Kidney Disease, Vitamin K Antagonist, Diabetes, High Cholesterol, Liver Disease
Interventions	Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests (Diagnostic test)
Dates	start 2026-04-01 (estimated), primary completion 2031-04-01 (estimated), completion 2031-07-01 (estimated), first posted 2026-01-30, last updated 2026-01-30

-Summary

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.

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+Arms and interventions

Arm	Interventions	Description
Blood clot	Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests	participants presenting with symptoms indicative of thromboembolic events
Infection/Inflammation	Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests	participants presenting with symptoms indicative of infection or inflammatory disorders
Heart disease	Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests	participants presenting with symptoms indicative of heart failure or acute coronary syndrome
Kidney disease	Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests	participants presenting with symptoms indicative of renal disorders
Blood thinners	Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests	participants with ongoing vitamin K antagonist therapy for at least four weeks
Diabetes	Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests	participants with suspected pre-Diabetes or diagnosed with Diabetes Mellitus Type 1 or Type 2
High cholesterol	Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests	participants presenting with symptoms indicative of Hypercholesterolemia
Liver disease	Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests	participants with symptoms indicative of hepatic disorders

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

+Outcome measures

Primary outcomes

Biomarker concentration [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.

+Eligibility

Sex: All, ages: 16 Years to any

Inclusion Criteria:

1. Willing and able to provide written informed consent.
2. Willing to comply with study procedures.
3. 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:

1\. Participants ≥ 18 years of age

Inclusion Criteria for Cohort F (Diabetes Cohort):

1\. Participants ≥ 16 years old

Exclusion Criteria:

1. Subjects deemed inappropriate for the study by the Principal Investigator.
2. Participants who have previously been enrolled in the EVOLVE study in the past 60 days.

Exclusion Criteria for Cohort E (Oral Anticoagulation Cohort):

1. Subjects who are currently taking non-vitamin K antagonist oral anticoagulants (NOACs) including but not limited to apixaban, dabigatran etexilate, edoxaban and rivaroxaban.
2. Subjects who have anti-phospholipid antibody syndrome (APS)
3. 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.