Capillary-Venous Paired Data Collection

Capillary-Venous Paired Data Collection

Capillary-venous paired data collection.

An iterative data collection study to continuously assess the performance of our Entia Liberty device with cancer patients and healthy volunteers. Our device enables a full blood count from a finger prick sample. The participants enrolled in the study will attend the study site for their routine venepuncture blood test. Once enrolled, they will have a finger prick test obtained by a Healthcare Professional (trained member of the clinical research team) to be tested on an Entia Liberty device. Within 4 hours of that same participant's routine venepuncture, a small amount of blood from the venepuncture will be also tested on a second Entia Liberty device in the laboratory. All the results from the capillary finger prick Liberty test, routine venepuncture blood test (gold standard reference method) and the venous blood Liberty test will be compared against each other to regularly assess that the improvements made on the measurement system of the device is sufficient.

CANCER COHORT:

Subjects fulfilling all of the following inclusion criteria are eligible for the study:

• Age ≥18 years old at the time of study entry
• Currently receiving standard-of-care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy
• Scheduled to be undergoing routine venous laboratory blood tests as part of the standard of care
• Able to provide capillary whole blood donation from pricking three different fingers on one hand
• Can provide written informed consent
• In the Investigator's opinion, is able and willing to comply with all study requirements

The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:

• History or current diagnosis of haematological malignancy (including bone and lymph)
• Inadequate use and understanding of the English language, requiring a translator

HEALTHY COHORT

Subjects fulfilling all of the following inclusion criteria are eligible for the study:

• Age ≥18 years old at the time of study entry
• Can provide written informed consent
• Have an NHS number (to enable ordering and tracking of laboratory FBC tests)
• Registered with a GP
• In the Investigator's opinion, is able and willing to comply with all study requirements

The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:

• Inadequate use and understanding of the English language, requiring a translator

• Been hospitalised within 90 days prior to their study visit

• Donated whole blood or plasma to a blood bank within the 90 days prior to the study visit

• History of vasovagal syncope following blood draw

• History or current diagnosis of the following conditions:

  • Cancer
  • Cardiovascular disease
  • Chronic kidney disease or end-stage renal disease
  • Bleeding disorder (including but not limited to Immune Thrombocytopenia (ITP), hemophilia, von Willebrand disease (VWD))
  • Blood clotting disorder (including but not limited to thrombophilia, antiphospholipid syndrome)
  • G6PD deficiency
  • Inflammatory bowel disease
  • Myelodysplastic syndrome
  • Ebola
  • Tuberculosis
  • HIV
  • Hepatitis B or C
  • Current diagnosis of Epstein-Barr Virus or Cytomegalovirus
  • Current diagnosis of diabetes mellitus, unless controlled by diet alone OR participant has been taking the same dose of the same medication for 4 weeks or more and are feeling fit and well.
  • Undergone organ transplantation
  • Anemia, unless the participant is feeling fit and well (no dizziness, fatigue, shortness of breath etc)