Collection of Blood Samples for New Diagnostic Devices 2
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLumiraDx UK Limited
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients will include those presenting at a medical unit (including but not limited to A\&E departments, hospital wards, or out-patient clinics) to their care team, in order to obtain a range of values for research of the new biomarkers on the LumiraDx system. Participants will include those who are expected to have (but are not limited to) biomarkers for diseases areas including embolism, infection or inflammation, cardiovascular, and renal cohorts.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Venous blood draw
Diagnostic testVenepuncture to draw up to 24mL of venous blood.
Fingerstick
Diagnostic testCapillary blood draw
Treatment groups
20,000 Participants
are divided into 1 treatment groupGroup A: Blood Draw2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 5 years2
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.
Time frame
Up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov