Research and Development of New Diagnostic Blood Tests Using the LumiraDx Platform Collecting Venous and Fingerstick Blood Samples from Adults with Various Health Conditions

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.

Collection of Blood Samples for New Diagnostic Devices 2