RecruitingNot ApplicableNCT05568966

Collection of Blood Samples for New Diagnostic Devices 2

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


Sponsor

LumiraDx UK Limited

Enrollment

20,000 participants

Start Date

Jul 11, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

To research and develop new state of the art diagnostic biomarkers on the LumiraDx Platform that are comparable to the approved gold standard reference methods and will radically enhance clinicians and patients ability to monitor health conditions and improve outcomes by delivering the results near patient at the point of care.


Eligibility

Min Age: 18 Years

Inclusion Criteria10

  • Subject 18 years of age.
  • Willing and able to provide written informed consent and comply with study procedures.
  • Patients attending a definitive care team with research capabilities which has been enroled in this collection study.
  • Patients who can read and understand written English.
  • The subject must present as one of the following cohorts:
  • Group A - Embolism Cohort - Patients presenting with symptoms indicative of thromboembolic events.
  • Group B - Infection or Inflammation Cohort - Patients presenting with symptoms indicative of infection or inflammatory disorders.
  • Group C - Cardiovascular Cohort - Patients presenting with symptoms indicative of heart failure or acute coronary syndrome.
  • Group D - Renal Cohort - Patients presenting with symptoms indicative of renal disorders.
  • Group E - Other Cohort. - Patients who are not eligible for any of the above groups.

Exclusion Criteria3

  • Subject \<18 years of age.
  • Vulnerable populations deemed inappropriate for the study by the sites Principal Investigator.
  • Patients who have previously been enroled in any LumiraDx NOVEL study in the past 3 months and re-entry would breach the 24mL and or 6 fingersitck maximums.

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Interventions

DIAGNOSTIC_TESTVenous blood draw

Venepuncture to draw up to 24mL of venous blood.

DIAGNOSTIC_TESTFingerstick

Capillary blood draw


Locations(7)

University Hospital Monklands

Airdrie, Scotland, United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom

St John's Hospital

Edinburgh, Scotland, United Kingdom

Glasgow Royal Infirmary

Glasgow, Scotland, United Kingdom

Queen Elizabeth University Hospital

Glasgow, Scotland, United Kingdom

Golden Jubilee National Hospital

Glasgow, Scotland, United Kingdom

Royal Alexandra Hospital

Paisley, Scotland, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05568966


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