Blood draw from volunteers for biomedical device development v2.0
Research type
Research Study
Full title
Blood draw from healthy volunteers for the development of biomedical devices
IRAS ID
260698
Contact name
Maiwenn Kersaudy-Kerhoas
Contact email
Sponsor organisation
Heriot Watt University
Clinicaltrials.gov Identifier
EP/R00398X/1, EPSRC funding; A1579/M717, Rose trees Trust funding; PS7305CA58, Scottish Enterprise
Duration of Study in the UK
2 years, 9 months, 31 days
Research summary
Circulating nucleic acids (cNAs) are biomarkers with an increasing application as diagnostic tools for screening and monitoring of various diseases, including cancer. However, the bottleneck restricting their clinical implementation is the pre-analytical step. The cNAs can be detected in very small amounts in blood plasma of healthy individuals. However, delayed blood processing may lead to inaccurate measurements or inhibition in downstream analytical methods.
The aim of this project is to develop novel point-of-care devices for medical blood sample preparation, preserving cNA levels and integrity. Development of automated platform for extracting cNAs from blood has the potential to standardise the pre-analytical step, reducing human errors and variation in sample processing. We will compare levels and integrity of cNAs in fresh blood samples (donated by healthy volunteers in the lab) and that of samples collected by Scottish National Blood Transfusion Service (SNBTS) to address the impact of pre-analytical parameters such as delayed sample processing and agitation of the sample during shipment. The newly developed method for microfluidic extraction of cNAs are assessed by comparing the concentration of cNAs in eluates obtained by the said method and a gold standard bench control, typically eluate obtained using a QIAGEN cNA extraction kit. The concentrations of cNAs are obtained via the quantitative PCR of a universal genetic marker such as ALU or LINE.
This study is looking to recruit healthy adult volunteers fulfilling the acceptance criteria (aged 18 and over, healthy, able to consent). The participants will come to the Chancellors Building, Little France Campus, University of Edinburgh to get blood drawn by a qualified phlebotomist. The participant can decide whether to come back for further blood donation(s) and/or be informed about the study (including updates and outcomes). The study will last for 2 years and 10 months.REC name
East of Scotland Research Ethics Service REC 1
REC reference
19/ES/0056
Date of REC Opinion
9 Jul 2019
REC opinion
Further Information Favourable Opinion