Collection of remnant material from unused blood donations (v1)
Research type
Research Study
Full title
Collection of remnant material donated at blood transfusion centres, under individual informed consent, which test positive for a variety of required biomarkers. Samples will be used to facilitate “Proof of Concept” and "Validation" studies for new diagnostic test kits, and may also be used for other appropriate applications.
IRAS ID
150238
Contact name
Simon Packer
Contact email
Research summary
Summary of Research
Patients with certain conditions present with elevated levels of various biomarkers in their blood, or its derivatives (serum, plasma, etc). Relevant material will be identified and collected following routine analysis of blood donations collected at a blood transfusion centre. Material unsuitable for transfusion is classed as remnant material. The remnant material will be stored and then transported to BBI Solutions. BBI Solutions will supply this material to various companies conducting research and development work on new diagnostic test kits or use them internally to assess products provided by BBI Solutions. The materials are important to ensure that the new kits are able to detect the required biomarker.
Summary of Results
The objective of this project was to support the supply of human plasma to be used to check the performance of laboratory tests used to diagnose and monitor disease progression. Access to this positive is essential to enable the manufacturers to adequately assess the performance of the test kits. BBI has been a well-known source of raw materials for these hospital test kits and the project framework has enabled BBI to work with a key strategic sourcing partner based in France to support the supply of these materials to the manufacturers of the hospital test kits. In recent years the demand for these materials has dropped as further suppliers have started up supply. BBI took the strategic decision not to continue with this sourcing project as the demand for the material subsided.
Project Work
BBI have engaged with Etablissment Francais Du Sang (EFS) as a supplier of blood products. Material supplied was from blood donations which were not suitable for blood transfusion as these units were tested and were found to have positive test results for specific disease states for example positive results for Hepatitis. To enable the supply of material from the French blood transfusion service the ethical parameters of the supply should be taken into account and a supply mechanism was needed to ensure that the donations were taken with the relevant informed consent so that the donors understood the use of their gift. In addition, a de-linking mechanism was employed to protect the anonymity of the donors.
BBI engaged a team of personnel to manage the process from the demand for the material from the hospital test kit manufacturer, assessment of the test parameter requirements, assessment of the availability at the donation centres, collection of the specific material with informed consent, the labelling/information exchange ( delinking the donors identity) and the logistics of the safe supply of the material to the end user through the use of a specific courier service.
Summary of materials
Description
Toxoplasma IgM Positive Citrate Plasma
Toxoplasma IgG Positive Citrate Plasma
Cytomegalovirus Immunoglobulin G Positive Citrate Plasma Cytomegalovirus Immunoglobulin M Positive Citrate Plasma Epstein Barr Virus Immunoglobulin M Positive Citrate Plasma Lyme/Anti-Borrelia IgM Plasma
HIV-1 Positive Citrate Plasma
Hepatitis B Surface Antigen Positive Citrate Plasma Hepatitis B Core Immunoglobulin M Positive Citrate Plasma Hepatitis A Immunoglobulin M Positive Citrate Plasma HCV Positive Citrate Plasma Rubella Immunoglobulin G Positive Citrate Plasma Rubella Immunoglobulin M Positive Citrate Plasma Herpes Simplex Virus IgM Positive Citrate Plasma Treponema Pallidum Positive Citrate PlasmaOutcomes
Over the period of the project the supply of material enabled the successful supply of material needed to effectively verify the performance of the specific hospital test kits targeting the disease parameters listed in the above summary.REC name
North of Scotland Research Ethics Committee 1
REC reference
14/NS/1020
Date of REC Opinion
28 Jul 2014
REC opinion
Further Information Favourable Opinion