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

LumiraDx UK Limited0 个研究点目标入组 30,000 人开始时间: 2026年4月1日最近更新: 2026年1月30日

适应症

干预措施

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 30,000
主要终点: Biomarker concentration

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Cross Sectional

入排标准

年龄范围: 16 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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):
•Cohort A - Embolism Cohort (participants presenting with symptoms indicative of thromboembolic events)
•Cohort B - Infection or Inflammation Cohort (participants presenting with symptoms indicative of infection or inflammatory disorders)
•Cohort C - Cardiovascular Cohort (participants presenting with symptoms indicative of heart failure or acute coronary syndrome)
•Cohort D - Renal Cohort (participants presenting with symptoms indicative of renal disorders)
•Cohort E - Oral Anticoagulation Cohort (participants with ongoing vitamin K antagonist therapy for at least four weeks)
•Cohort F - Diabetes Cohort (participants with suspected pre-Diabetes or diagnosed with Diabetes Mellitus Type 1 or Type 2)
•Cohort G - Lipid Cohort (participants presenting with symptoms indicative for Hypercholesterolemia )
•Cohort H - Liver Cohort (participants with symptoms indicative of hepatic disorders).
•Inclusion Criteria for Cohorts A, B, C, D, E, G, and H:
•1. Participants ≥ 18 years of age
•Inclusion Criteria for Cohort F (Diabetes Cohort):
•1. Participants ≥ 16 years old

排除标准

•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.
•Exclusion Criteria for Cohort E (Oral Anticoagulation Cohort):
•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.