Blood Donation of Healthy Blood for Prototype Testing at Entia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Entia Ltd
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The difference in counts of the device tested blood vs the gold standard tested blood.
研究概览
简要总结
The investigators are recruiting healthy volunteers to donate 1-5 (depending on study visits. and donors will be notified upon invitation) finger prick blood samples or venous samples to Entia for the further development and testing of our blood analyser. The venous samples are taken by a registered nurse hired via a third party company. The results of the blood tests are not informed to the participants unless they explicitly ask for it.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 21 years Apparently healthy Able to provide written informed consent Registered with a general practitioner (GP)
排除标准
- •Inadequate understanding of the English language (written and verbal) that would require 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 Pregnant at the time of the study visit Breastfeeding at the time of 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)
研究组 & 干预措施
Capillary Sample
This group donates finger prick blood samples to Entia for the purpose of development.
干预措施: Affinity (Diagnostic Test)
Venous Sample
This group donates venous blood samples to Enta, taken by a registered nurse.
干预措施: Affinity (Diagnostic Test)
结局指标
主要结局
The difference in counts of the device tested blood vs the gold standard tested blood.
时间窗: 3 years
Venous blood drawn will be tested on a laboratory analyser, in which the results will be compared against the results when tested on Entia's analyser.
The difference in counts of the device tested blood vs the gold standard tested blood.
时间窗: Day 1
Venous blood drawn will be tested on a laboratory analyser, in which the results will be compared against the results of blood samples (whether capillary or venous) when tested on Entia's analyser.
次要结局
未报告次要终点