Scottish Donation and Transplant Group written update: August 2024

Histocompatibility and Immunogenetics (HI) support for transplantation in Scotland

Update given by:

• Dr David Turner, Consultant Clinical Scientist, Scottish National Blood Transfusion Service
• Dr Ann-Margaret Little, Consultant Clinical Scientist, NHS Greater Glasgow and Clyde

Staffing 

• Glasgow HI: Fully staffed
• Edinburgh HI: Fully staffed

On call rotas

The Consultant/Principal Clinical Scientist rota supporting deceased donor kidney, Simultaneous Pancreas-Kidney (SPK), islet and cardiac transplantation in Scotland continues as a 1:4.

No issues with Biomedical Scientist/ Clinical Scientists rota for on call lab work.

Donor Human Leukocyte Antigen (HLA) typing

Since April 2022, this service is commissioned and funded by NHS Blood and Transplant (NHSBT) in England. In devolved areas of the UK, HI and microbiology labs are not funded centrally from NHSBT but are obliged to sign a contract to agree to Key Performance Indicators (KPIs). 

KPI for HLA types being reported within four hours of sample receipt (target is 90%).

Quarter 1 in 2024/25: 76% (in Edinburgh) and 100% (in Glasgow)

Results have been reported to NHS Blood and Transplant (NHSBT). 

Donor Characterisation Electronic Results Transfer (DCERT)

NHSBT to introduce electronic reporting of deceased donor HLA typing and microbiology/virology results to the Organ Tissue Donation Transplantation (OTDT) directorate at NHSBT, to avoid transcription errors. Roll out for HLA typing for both Glasgow and Edinburgh labs is now planned for September 2024.

NHSBT LivingPath

This electronic system for managing patient information for the National Kidney Sharing Scheme (NKSS) is now fully live. System is working well.

Human Leukocyte Antigen-incompatible (HLAi) transplants facilitated by Imlifidase

UK British Transplant Society guidelines for the use of imlifidase to facilitate renal transplant for highly HLA sensitised patients with long waiting time are published. In Scotland before patients are considered for imlifidase they are discussed at a joint multidisciplinary team. HI processes have been agreed and policies/standard operating procedures updated. One patient at both sites has had ‘unacceptable’ antigens removed to increase offers that may require the use of imlifidase.

In Vitro Diagnostics Directive to the In Vitro Diagnostic Regulations (IVDR) impact on HI services

Currently both Edinburgh and Glasgow HI labs use methods for HLA antibody specificity definition that utilise a so called ‘half bead’ protocol, i.e. following a thorough validation a reduced volume of reagent is used in assays in order to produce more tests from each kit purchased. Our understanding is that following the transition from the In Vitro Diagnostics Directive to the In Vitro Diagnostic Regulations (IVDR), anticipated in July 2025, the use of the ‘half bead’ protocol will not be possible. This is inevitably going to lead to an increased cost per test of HLA antibody specificity (Single Antigen Bead (SAB)) testing.