Immunosuppression and immunodeficiency - Tissue - deceased donors

Essential information

Obligatory

Must not donate if:

Immunosuppressed or otherwise immunodeficient.

Discretionary

1. Donors who are on immunosuppressive therapy or are otherwise immunodeficient (if the underlying condition is not a contraindication):
   
   If ALL the following criteria are met:
   
   1. The quality of the tissue being donated is not affected, and
   2. NAT testing is performed for HIV, HCV and HBV in addition to mandatory antibody tests and shown to be negative, and
   3. The tissue being donated is not affected by severe local infection and there is no evidence of systemic infection, OR (for corneas only): In cases of bacterial infection (where there is no active ocular infection) and the corneas are to be stored by organ culture.
      
      Donor may be accepted, subject to a documented risk assessment. See Additional information below.
      
      
2. Donors with recovered immunodeficiency:
   
   Refer to a Designated Clinical Support Officer.

Supporting information

See if relevant

• Autoimmune disease
• Immunoglobulin therapy
• Infection, acute
• Infection, chronic
• Monoclonal antibody therapy and other biological modalities
• Steroid therapy

Additional information

The Human Tissue (Quality and Safety for Human Application) Regulations, 2007, as amended, specifies a range of allogeneic donor deferral criteria. These are set out in Annex A of the Human Tissue Authority (HTA) 'Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment'. Regulatory requirements for donor testing are set out in Annex B of the Guide and specify the requirement for serological testing irrespective of NAT testing.

Annex A, part 1.1.8 states:

"Indications that test results of donor blood samples will be invalid due to…treatment with immunosuppressive agents."

Whilst antibody detection relies on the host response, antigen and molecular assays directly detect components of the infectious agent. Assays which directly detect the virus are not affected adversely by immunosuppression and are appropriate to use to support decision making in this situation. This is permitted under the SaBTO 'Guidance on the microbiological safety of human organs, tissues and cells used in transplantation' (2020).

The regulatory requirement, as set out in the HTA Guide is as follows:

Para 85:

"Donors must be excluded from donation if any of the criteria in Annex A apply unless donation is justified on the basis of a documented risk assessment approved by the Designated Individual (DI)."

To comply with the regulatory requirement, Tissue Establishments (TEs) must ensure that they have a current documented risk assessment that covers all the tissues in question before authorising a donation for clinical use on the basis of the Discretionary criteria set out above.

Donors on immunosuppression or who are otherwise immunodeficient may be prone to an increased risk of infection and symptoms may be masked by immunosuppressive medication. All available information, including any medication (e.g. monoclonal antibodies, immunoglobulins), must be carefully assessed as part of donor evaluation and expert opinion sought where required.

Regulatory information

This advice is a requirement of the EU Tissue and Cells Directive.

Reason for change:

The entry has been renamed from ‘Immunosuppression’ to ‘Immunosuppression and immunodeficiency’. Discretionary guidance has been reformatted to improve readability, and it has been clarified that all types of immunodeficiency need to be considered, not just those secondary to treatment. ‘See if relevant’ links have been updated.

Version:

Immunosuppression and monoclonal antibody treatments

Version details:

TD-DSG Edition 203 Release 67 (6 October 2026)