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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood clot | participants presenting with symptoms indicative of thromboembolic events |
| |
| Infection/Inflammation | participants presenting with symptoms indicative of infection or inflammatory disorders |
| |
| Heart disease | participants presenting with symptoms indicative of heart failure or acute coronary syndrome |
| |
| Kidney disease | participants presenting with symptoms indicative of renal disorders |
| |
| Blood thinners | participants with ongoing vitamin K antagonist therapy for at least four weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker concentration | Blood samples will be used to take a quantitative baseline measurement of 1 or more biomarkers associated with the following health conditions:
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. | Baseline |
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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):
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:
Exclusion Criteria for Cohort E (Oral Anticoagulation Cohort):
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UK-based adults presenting to a study site and meeting the eligibility criteria. There are no demographic requirements for this study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zoe Pounce, PhD | Contact | +44 1786 533 206 | zoe.pounce@roche.com |
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Whole blood and/or plasma
| Diabetes | participants with suspected pre-Diabetes or diagnosed with Diabetes Mellitus Type 1 or Type 2 |
|
| High cholesterol | participants presenting with symptoms indicative of Hypercholesterolemia |
|
| Liver disease | participants with symptoms indicative of hepatic disorders |
|
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D007239 | Infections |
| D007249 | Inflammation |
| D006331 | Heart Diseases |
| D007674 | Kidney Diseases |
| D003920 | Diabetes Mellitus |
| D006937 | Hypercholesterolemia |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D004066 | Digestive System Diseases |
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