Blood Clots, Diabetes, Heart Disease, High Cholesterol, Infection and Inflammatory Reaction, Kidney Disease, Liver Disease, Vitamin K Antagonist
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTBlood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
Sponsors
LumiraDx UK Limited
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
CONTACTZoe Pounce, PhD
Outcome results
None listed