EVOLVE
Research type
Research Study
Full title
cobas® lumira Collection of Venous and Capillary Blood Samples for the Research, Optimization and Calibration of New Diagnostic Devices
IRAS ID
366798
Contact name
Roy Gardner
Contact email
Sponsor organisation
LumiraDx UK Ltd
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
This is a prospective, multi-centre blood sample collection study from approximately 30,000 participants across sites within the UK.
LumiraDx UK Ltd (hereafter referred to as ‘LumiraDx’) have developed a small portable, diagnostic point of care instrument - the cobas® lumira, which is an in-vitro diagnostic medical device with single use test strips, and the capability to allow multiple tests to be performed on the same platform for multiple assays and various different sample matrices (venous blood, capillary blood or plasma).
The purpose of the study is to collect venous and capillary blood samples from adult participants with the disease areas of interest including (but not limited to) embolisms and anti-coagulant therapy, infection, cardiovascular, diabetes, renal, liver, lipid to research, optimise and evaluate the agreement between the LumiraDx Point of Care diagnostic biomarkers and the gold standard lab analysers.
REC name
West of Scotland REC 4
REC reference
26/WS/0016
Date of REC Opinion
29 May 2026
REC opinion
Further Information Favourable Opinion