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

Description

This is a comparative research study to research, optimise and develop new state of the art diagnostic biomarkers on the LumiraDx Platform that will radically enhance clinicians and patients ability to monitor chronic health conditions which improve outcomes at the point of care and that are comparable to gold standard reference methods. The LumiraDx POC Platform consists of an in vitro diagnostic instrument, used with single use test strips for different disease biomarkers. This next generation point of care device is intended to allow multiple tests to be performed on the same platform for blood, plasma, serum, swab, and urine samples.

Research activities will be completed on blood samples collected from a maximum of 20,000 patients to assess the performance of the new biomarkers undergoing research. Patients will include those presenting at a medical unit (including but not limited to A&E departments, hospital wards, or out-patient clinics) to their care team, in order to obtain a range of values for research of the new biomarkers on the LumiraDx system. Participants will include those who are expected to have (but are not limited to) biomarkers for diseases areas including embolism, infection or inflammation, cardiovascular, and renal cohorts.

Each patient must give appropriate written informed consent and satisfy all the inclusion/exclusion criteria prior to any study procedures. Patient participation in this study will take a maximum of 45 minutes of the patient's time. Patients presenting for a subsequent clinic visit or admission may be approached to participate in the study again, a maximum of 24mL of venous whole blood and up to 6 capillary fingersticks (obtained with a high flow lancet) may be collected from each patient within a three month period. Where possible, study samples should be taken at the same time as any standard of care blood draws or from patients with a cannula in-situ, a separate study venipuncture is not a requirement for this protocol. Study samples will be used for research, evaluation, optimisation and development activities into new biomarkers on the LumiraDx Platform in comparison with the gold standard reference method for the disease area to ensure comparable performance. Samples may also be used for troubleshooting and calibrating LumiraDx assays developed.

Sample collection will be separated into 2 phases depending upon the research needs. Patients can participate in both phases:

Phase 1: Only venous blood samples will be drawn by the HCP. These samples will be tested on the LumiraDx System and/or device(s) under development and also tested on the appropriate reference method for comparison. This testing may occur at the clinical site and/or at LumiraDx UK Ltd.

Phase 2: Venous blood samples and capillary fingerstick samples will be collected by the HCP. These samples may be tested on the LumiraDx Platform and also tested on the appropriate reference method for comparison. The fingerstick samples will be tested on the LumiraDx device. The processing of samples may occur at the clinical site and/or at LumiraDX UK Ltd.

The samples will be identified by patient identification number, anonymising the patient's identifiable information. These blood samples will be sent to LumiraDx UK Ltd for storage and future testing. No genetic testing will be carried out on samples. Samples may also be used to research, optimise, develop, modify and calibrate products and platforms for measuring biomarkers including, but not limited to, Troponin, NT-pro BNP, BNP, CK-MB, D-Dimer, NGAL, Cystatin C, Myoglobin, Galectin-3, CRP, AST, ALT, Lipids, Coagulation, Prolactin, and Beta-hCG.

Patients who reattend or are admitted to the medical unit (including but not limited to A&E departments, hospital wards or out-patient clinics) may be asked for further sampling. A total of 24mL and 6 capillary fingersticks (obtained using high flow lancets) will not be exceeded over the three month period from consent, patients may opt out of further contact. Any patient reattending three months post consent will be treated as a new patient.

Data will be recorded on the Case Report Forms. The patient demographics data collected may include: age; sex; ethnicity, pregnancy status, NYHA classification, current medications at time of blood collection including their indications, significant medical history, relevant local blood test results, reason(s) for presenting, and confirmed diagnosis.

Details