Collection of Blood Samples for New Diagnostic Devices 2

NCT05568966 | Recruiting

• 1 other identifier: S-CLIN-PROT-00025
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Embolism and Thrombosis; Cardiovascular; Renal; Inflammation; Infections

Outcome Measures

Primary Outcomes (2)

• Measurement of blood samples from patients with infection, cardiovascular disease, embolism or renal disease in a reference method and in a novel LumiraDx method.

  Measurement of blood samples in a reference method and in a novel LumiraDx method to assess accuracy of the LumiraDx method in patients with infection, cardiovascular disease, embolism or renal disease. Accuracy will be assessed by regression analysis against a reference method.

  Up to 5 years

• Multiple measurements of blood samples from patients with infection, cardiovascular disease, embolism or renal disease in a novel LumiraDx method.

  Multiple measurements of blood samples in a novel LumiraDx method to assess precision of the method in patients with infection, cardiovascular disease, embolism or renal disease. Precision will be assessed by coefficient of variation (%CV) estimates.

  Up to 5 years

Study Arms (1)

Blood Draw

EXPERIMENTAL

Venous blood draw up to 24mL and/or 6 capillary fingersticks Interventions: Diagnostic Test: Venepuncture Diagnostic Test: Fingerstick

Diagnostic Test: Venous blood draw; Diagnostic Test: Fingerstick

Interventions

Venous blood draw DIAGNOSTIC_TEST

Venepuncture to draw up to 24mL of venous blood.

Blood Draw

Fingerstick DIAGNOSTIC_TEST

Capillary blood draw

Blood Draw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LumiraDx UK Limited: lead

Study Sites (7)

University Hospital Monklands

Airdrie, Scotland, ML6 0JS, United Kingdom

RECRUITING

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

RECRUITING

St John's Hospital

Edinburgh, Scotland, EH54 6PP, United Kingdom

RECRUITING

Glasgow Royal Infirmary

Glasgow, Scotland, G4 0SF, United Kingdom

RECRUITING

Queen Elizabeth University Hospital

Glasgow, Scotland, G51 4TF, United Kingdom

RECRUITING

Golden Jubilee National Hospital

Glasgow, Scotland, G81 4DY, United Kingdom

RECRUITING

Royal Alexandra Hospital

Paisley, Scotland, PA2 9PN, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Embolism and Thrombosis; Inflammation; Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Roy Gardner

  NHS National Waiting Times Centre Board

  PRINCIPAL INVESTIGATOR

• Alasdair Gray

  NHS Lothian

  PRINCIPAL INVESTIGATOR

• Allan Cameron

  NHS Greater Glasgow & Clyde

  PRINCIPAL INVESTIGATOR

• David Lowe

  NHS Greater Glasgow & Clyde

  PRINCIPAL INVESTIGATOR

• Santosh Bongale

  NHS Greater Glasgow & Clyde

  PRINCIPAL INVESTIGATOR

• Fiona Hunter

  NHS Lanarkshire

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Craig

CONTACT

0044 1786 533232; novel-2@lumiradx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: October 6, 2022
• Study Start: July 11, 2022
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7)