What is this study trying to find out about health monitoring?

This study is researching new diagnostic biomarkers on the LumiraDx Platform to help clinicians and patients better monitor chronic health conditions near the point of care. It compares new methods with approved standard tests to improve disease monitoring. The study is sponsored by LumiraDx UK Limited and involves collecting blood samples from patients with various conditions.

Who may be eligible for this clinical trial?

Adults 18 years or older who can read and understand English and are attending a care team involved in this study may be eligible. Patients should have symptoms related to embolism, infection or inflammation, cardiovascular, or renal conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this clinical trial?

Study-related care, including the collection of blood samples and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05568966

Collection of Venous and Capillary Blood Samples for the Research, Optimisation and Calibration of New Diagnostic Devices 2

Led by LumiraDx UK Limited · Updated on 2026-04-22

20000

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a study to develop and improve new diagnostic biomarkers using the LumiraDx Platform. This platform aims to enhance the ability of clinicians and patients to monitor chronic health conditions at the point of care by providing results comparable to approved gold standard methods. The study includes patients with conditions related to embolism, infection or inflammation, cardiovascular, and renal diseases. The study involves collecting blood samples from up to 20,000 patients, including venous blood and capillary fingerstick samples. Sample collection is divided into two phases Phase 1 collects venous blood tested using LumiraDx and reference methods, while Phase 2 includes both venous and fingerstick samples tested similarly. Samples will be anonymized and sent to LumiraDx UK Ltd for storage and future testing to optimize and calibrate new biomarkers. Participants will spend up to 45 minutes in the study, during which blood samples are collected, ideally alongside standard care blood draws. Data on patient demographics, medical history, and current medications will be recorded. The primary outcome is to measure blood samples from patients with various conditions using both reference and LumiraDx methods over up to five years. Patients may be re-sampled up to three months after initial consent, with limits on total blood volume collected.

CONDITIONS

Brief Title

Collection of Blood Samples for New Diagnostic Devices 2

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Subject 18 years of age.
Willing and able to provide written informed consent and comply with study procedures.
Patients attending a definitive care team with research capabilities enrolled in this collection study.
Patients who can read and understand written English.
The subject must present as one of the following cohorts: Embolism Cohort with symptoms of thromboembolic events; Infection or Inflammation Cohort with symptoms indicative of infection or inflammatory disorders; Cardiovascular Cohort with symptoms of heart failure or acute coronary syndrome; Renal Cohort with symptoms indicative of renal disorders; Other Cohort not eligible for the above groups.

You will not qualify if you...

Subject under 18 years of age.
Vulnerable populations deemed inappropriate for the study by the site's Principal Investigator.
Patients previously enrolled in any LumiraDx NOVEL study in the past 3 months if re-entry would exceed the maximum blood or fingerstick limits.

Research Team

David Craig

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