Not Yet RecruitingNot Applicable

Cobas® Lumira Collection of Venous and Capillary Blood Samples for the Research, Optimization and Calibration of New Diagnostic Devices

30,000 participantsStarted 2026-04

Plain-language summary

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.

Who can participate

Age range16 Years

SexALL

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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):

Exclusion criteria

✕. Subjects deemed inappropriate for the study by the Principal Investigator.
✕. Participants who have previously been enrolled in the EVOLVE study in the past 60 days.
✕. Subjects who are currently taking non-vitamin K antagonist oral anticoagulants (NOACs) including but not limited to apixaban, dabigatran etexilate, edoxaban and rivaroxaban.
✕. Subjects who have anti-phospholipid antibody syndrome (APS)
✕. The participant is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, experimental drug, or experimental device including either treatment or therapy.

What they're measuring

Biomarker concentration

Timeframe: Baseline

Trial details

NCT IDNCT07378514

SponsorLumiraDx UK Limited

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2031-04

Contact for this trial

Zoe Pounce, PhD

+44 1786 533 206 zoe.pounce@roche.com

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