Validation of C3d assay
Research type
Research Study
Full title
Evaluation of the Lifecodes C3d assay to form part of an algorithm for analysing HLA antibody status using Luminex Single Antigen technology in highly sensitised patients awaiting renal transplantation.
IRAS ID
225745
Contact name
Ann-Margaret Little
Contact email
Sponsor organisation
NHS Greater Glasgow & Clyde R&D department
Duration of Study in the UK
0 years, 4 months, 3 days
Research summary
The number of patients who are highly sensitized to HLA antigens continue to increase on the renal transplant waiting list, 98% of long waiting patients have HLA antibodies that will react with more than 85% of potential donors (calculated reaction frequency (cRF) > 85%). Currently unacceptable HLA antigens are defined by single antigen luminex assay and listed with organ donation and transplantation (ODT) and patients will not be offered allografts expressing these antigens. Strategies are needed to prevent long term dialysis, patients becoming unsuitable for transplant and the death of patients waiting on the active list. Transplantation across weak or less harmful donor specific antibodies plus the delisting of unacceptable antigens are possible approaches to reducing cRF and increasing chance of transplant. Current studies are indicating the implication of complement binding antibodies as a detrimental factor in antibody mediated rejection. The C3d assay may be a useful prognostic tool in stratifying clinical risk as it detects C3d binding DSA and as C3d is positioned further downstream of the complement cascade it may better reflect the clinical nature of pathogenic DSA. Within this project C3d results will be compared with complement dependent cytotoxicity crossmatch results to determine if complement binding antibodies have a higher risk of positivity and therefore hyperacute rejection.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0202
Date of REC Opinion
11 May 2017
REC opinion
Further Information Favourable Opinion