Collection of Blood Samples for New Diagnostic Devices 2

Sponsor
LumiraDx UK Limited
Study ID
NCT05568966
Status
Recruiting

Conditions

  • Cardiovascular
  • Embolism and Thrombosis
  • Infections
  • Inflammation
  • Renal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venous blood draw — DIAGNOSTIC_TEST
    Venepuncture to draw up to 24mL of venous blood.
  • Fingerstick — DIAGNOSTIC_TEST
    Capillary blood draw

Study Details

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.

Key Dates

First listed
Oct 6, 2022
Start date
Jul 11, 2022
Status verified
Mar 2026
Primary completion
Aug 20, 2026
Completion
Aug 20, 2026

Study Design

Enrollment
20,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

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

Primary Outcome Measure

Measurement of blood samples from patients with infection, cardiovascular disease, embolism or renal disease in a reference method and in a novel LumiraDx method. [ Time Frame: Up to 5 years ]

Central Contacts

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