Collecting blood samples to develop new diagnostic devices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to research and develop new diagnostic biomarkers using the LumiraDx Platform, which will enhance the ability of clinicians and patients to monitor chronic health conditions at the point of care. By collecting blood samples from up to 20,000 patients presenting with various health issues, the study will compare the performance of these new biomarkers against established gold standard methods. The LumiraDx Platform allows for multiple tests to be conducted on a single device, facilitating efficient and effective health monitoring. Participants will provide informed consent and undergo a brief blood draw as part of the study.

Why it matters

Who can join: the full rules

Inclusion Criteria

* 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:

  1. Group A - Embolism Cohort - Patients presenting with symptoms indicative of thromboembolic events.
  2. Group B - Infection or Inflammation Cohort - Patients presenting with symptoms indicative of infection or inflammatory disorders.
  3. Group C - Cardiovascular Cohort - Patients presenting with symptoms indicative of heart failure or acute coronary syndrome.
  4. Group D - Renal Cohort - Patients presenting with symptoms indicative of renal disorders.
  5. Group E - Other Cohort. - Patients who are not eligible for any of the above groups.

Exclusion Criteria

* 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.

Where it's running

• University Hospital Monklands
  Airdrie, Scotland, United Kingdom Recruiting
• Royal Infirmary of Edinburgh
  Edinburgh, Scotland, United Kingdom Recruiting
• St John's Hospital
  Edinburgh, Scotland, United Kingdom Recruiting
• Glasgow Royal Infirmary
  Glasgow, Scotland, United Kingdom Recruiting
• Queen Elizabeth University Hospital
  Glasgow, Scotland, United Kingdom Recruiting
• Golden Jubilee National Hospital
  Glasgow, Scotland, United Kingdom Recruiting

Study contacts

• Principal investigator: Roy Gardner — NHS National Waiting Times Centre Board
• Study coordinator: David Craig
• Email: novel-2@lumiradx.com
• Phone: 0044 1786 533232

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.