An observational study in Blood Clots, Infection and Inflammatory Reaction and Heart Disease, sponsored by LumiraDx UK Limited. Not yet recruiting. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by LumiraDx UK Limited · Observational
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.
955 studies on the registry are indexed under Thrombosis; 171 are open to participants now.
This study's planned enrollment of 30,000 is above the median of 173 across 384 observational studies indexed under Thrombosis.
Browse Thrombosis studies →LumiraDx UK Limited is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
UK-based adults presenting to a study site and meeting the eligibility criteria. There are no demographic requirements for this study
Inclusion Criteria:
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):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
participants presenting with symptoms indicative of thromboembolic events
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
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
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
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
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
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
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
Diagnostic Test: Blood 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
Biomarker concentration
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.
Time frame: Baseline
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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LumiraDx UK Limited