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

LumiraDx

Status: Begins enrollment in 1 month

Conditions: Diabetes; Blood Clots; Heart Disease; High Cholesterol; Vitamin K Antagonist; Infection and Inflammatory Reaction; Liver Disease; Kidney Disease

Treatments: Diagnostic Test: Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests

Study type: Observational

Funder types: Industry

Identifiers

NCT07378514

RD007454

Details and patient eligibility

About

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.

Enrollment: 30,000 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30,000 participants in 8 patient groups

Blood clot

Description:

participants presenting with symptoms indicative of thromboembolic events

Treatment:

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

Infection/Inflammation

Description:

participants presenting with symptoms indicative of infection or inflammatory disorders

Treatment:

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

Heart disease

Description:

participants presenting with symptoms indicative of heart failure or acute coronary syndrome

Treatment:

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

Kidney disease

Description:

participants presenting with symptoms indicative of renal disorders

Treatment:

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

Blood thinners

Description:

participants with ongoing vitamin K antagonist therapy for at least four weeks

Treatment:

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

Diabetes

Description:

participants with suspected pre-Diabetes or diagnosed with Diabetes Mellitus Type 1 or Type 2

Treatment:

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

High cholesterol

Description:

participants presenting with symptoms indicative of Hypercholesterolemia

Treatment:

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

Liver disease

Description:

participants with symptoms indicative of hepatic disorders

Treatment:

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