Independent report

SaBTO: Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) annual report 2022 to 2023

Published 28 March 2024

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This publication is available at https://www.gov.uk/government/publications/sabto-annual-report-2022-to-2023/sabto-advisory-committee-on-the-safety-of-blood-tissues-and-organs-sabto-annual-report-2022-to-2023

The report covers the:

  • 46th meeting of SaBTO on 24 May 2022
  • 47th meeting of SaBTO on 27 September 2022
  • 48th meeting of SaBTO on 7 December 2022
  • 49th meeting of SaBTO on 9 March 2023
  • 50th meeting of SaBTO on 15 June 2023
  • 51st meeting of SaBTO on 28 September 2023
  • broader activities of working parties and contributions to the committee

Topics considered in 2022 to 2023

Review of pathogen inactivation technologies in screening methods

In May 2022, members of SaBTO convened to review their position on pathogen reduction and inactivation technologies for the safety of platelet concentrates, considering recent evidence. The current SaBTO position, which had not been reviewed since 2014, does not recommend the introduction of pathogen inactivation of platelets for UK blood services.

All 4 UK blood services currently use bacterial screening to ensure the safety of platelet concentrates, rather than pathogen inactivation techniques. In its assessment, SaBTO noted possible benefits of pathogen inactivation including protection against some new and emerging transfusion transmissible infections. However, pathogen inactivation is only partially effective against other pathogens such as hepatitis E virus and ineffective against variant Creutzfeldt-Jakob disease (vCJD). SaBTO also discussed the significant logistical and financial implications of implementing pathogen inactivation technologies. The committee also acknowledged that evidence gathered by the Serious Hazards of Transfusion (SHOT) hemovigilance scheme supported the safety of current measures adopted by the UK blood services.

Based on this assessment, SaBTO made the following recommendations – that:

  • there should be no change in SaBTO’s current position on screening technologies for maintaining the microbiological safety of platelets
  • current recommendations will be reviewed in 3 years or sooner if new relevant information or technologies become available

Update on KSHV/HHV-8 testing methods

The virology review subcommittee considered the current scientific evidence to assess the extent and impact of donor-related Kaposi’s sarcoma-associated herpesvirus (KSHV) infection on the outcome of solid-organ recipients and the feasibility of implementing interventions. Several cases of primary KSHV - also known as human herpesvirus type-8 (HHV-8) - infection, some of which were fatal, have been observed in recent years in recipients of solid organ transplants in the UK.

As noted in SaBTO’s 2021 to 2022 annual report, the committee considered various interventions ranging from raising public awareness to using virological testing strategies, including the use of serological testing, which can identify asymptomatic and infected individuals, and KSHV antibody testing.

A report recommending the use of universal serological screening of deceased donors for KSHV infection was agreed by SaBTO in August 2021. Subsequently, KSHV/HHV-8 testing in solid organ transplantation commenced in 2022. Data on the impact of testing will be reviewed in due course.

Update on the occult hepatitis B infection (OBI) working group

SaBTO assessed the current risk of transfusion-transmitted infection from blood donors with occult hepatitis B virus (HBV). Occult HBV refers to infection with HBV in donors who have undetectable levels of the HBV surface antigen, but do have HBV DNA in their peripheral blood and detectable levels of HBV core antibodies (anti-HBc).

After consideration of different options to identify occult HBV donors, SaBTO recommended that all UK blood donors should be tested at least once for anti-HBc. Subsequently, the UK blood services implemented routine anti-HBc screening in May 2022. The UK blood services also agreed to carry out lookback investigations to identify blood donors with occult HBV.

In June 2023, SaBTO considered a report to assess the impact of the additional testing 12 months after it was introduced. The report found that all blood services were implementing testing. Donors with evidence of past HBV infection are deferred from donation, while those with intermediate results are deferred for 3 to 6 months and then re-tested.

FAIR III tissues and cells

The For Assessment of Individualised Risk (FAIR) III steering group (established in 2021) made recommendations for the blood donor selection policy to move to an individualised risk-based approach.

Following recommendations from the group, in June 2021, the government updated the donor selection criteria, providing more opportunities for men who have sex with men (MSM) in long-term relationships to donate blood in England.

The group has also assessed whether this recommendation can be applied to tissue and cell donors from MSM. The group has recommended that:

  • an individualised risk-based approach should be implemented in full to living tissue donors, provided they are asked additional questions and are eligible post review
  • an individualised risk-based approach should be implemented in full for cord blood and stem cell donors
  • an individualised risk-based approach should be implemented in full for deceased donors

SaBTO agreed to support the application of the FAIR recommendations to tissue and cell donors from MSM. UK health ministers agreed to implement these changes in 2023. A review will take place 12 months after implementation.

Review of microbiological safety guidelines

SaBTO first published guidance on the microbiological safety of human organs, tissues and cells in 2011. The microbiological safety guidelines were initially published to help advise on the safe use of donor organs, tissues and cells to minimise the risk of infection in most patients. The microbiological landscape continues to change, presenting new infections and creating more difficulty in managing transmission of diseases. Since 2011, SaBTO has updated the guidance regularly according to the latest research and evidence.

An update of the microbiological safety guidelines was published on 15 March 2023.

The most recent iteration of the guidelines sees additional guidance and amendments including:

  • around UK legislation since leaving the EU in 2021
  • clarification on who should provide expert guidance on the interpretation of microbiological results
  • further guidance on infections that are present in the blood at the time of donation, including the presence of mpox (monkeypox)
  • updated residual risk estimates in interpreting donor test results

SaBTO has also produced a simple guide to aid the healthcare professional in the safe and appropriate use of donated organs.

In 2022, the Department of Health and Social Care (DHSC) commissioned SaBTO to consider the latest scientific evidence around gamete donation with the aim of understanding if in vitro fertilisation (IVF) could be made more inclusive. The Gamete Donation Working Group carried out this work.

Current assisted conception regulations stipulate that gamete donors must be screened for human immunodeficiency virus (HIV), HBV and hepatitis C virus (HCV). Under the existing Human Fertilisation and Embryology Act 1990, those who test positive for any of these infections are unable to donate their gametes to known recipients due to the risk of transmission of those infections to the recipient.

The Gamete Donation Working Group’s Review of existing gamete donation guidance and further recommendations assessed current evidence and concluded that the effectiveness of current treatments for these viruses indicates that existing regulations are outdated.

Based on the assessment of the working group, SaBTO made the following recommendations:

  • allow gamete donation from individuals with HIV who have an undetectable plasma HIV viral load
  • allow gamete donation from individuals who are hepatitis B surface antigen negative, anti-HBc positive and have undetectable levels of plasma HBV DNA
  • HCV screening for gamete donors should incorporate both anti-HCV and HCV RNA testing. Only those gamete donors who are shown to be HCV RNA positive should be deferred from donation
  • additional screening requirements for female same-sex couples in an intimate relationship are removed as there is no microbiological reason to suggest there would be any adverse effects in addition to the risks of gamete donation from any other eligible group

Subsequently, in October 2023, DHSC announced that same-sex couples where one or both partners have HIV but have an undetectable viral load will now be able to access IVF treatment. Additionally, female same-sex couples hoping to conceive through reciprocal IVF will no longer have to go through expensive screening processes.

HEV working group

The Hepatitis E (HEV) Working Group was established in October 2020 to re-examine the effectiveness of current HEV screening of blood and platelet (apheresis) donors, and advise on whether it provides sufficient mitigation of transmission risk. HEV testing is applied universally to all whole blood, platelet and plasma donations, as well as donors of organs and tissues.

The working group investigated the options for testing and donor selection strategies available to reduce HEV transmission risk, including the current residual risk of HEV transmission from red blood cells, platelets and plasma, and the cost-effectiveness of introducing assays with increased sensitivity.

The working group produced a report in June 2023 highlighting the following recommendations:

  • SaBTO recommends no changes to current HEV testing procedures
  • testing individual donations for HEV is not cost-effective, based on current risk
  • if incidents of HEV transmission occur, SaBTO will continue to evaluate the risk tolerability as it applies to HEV screening
  • SaBTO will raise awareness of HEV with professional bodies, encouraging early diagnosis and utilisation of treatments for HEV
  • SaBTO will annually review the reported incidence of HEV infections in the wider community using epidemiological data in UK blood and platelet donors
  • a further review of HEV testing should be undertaken in 5 years

Membership 2022 to 2023

  • Professor James Neuberger (Chair)
  • Dr Akila Chandrasekar
  • Ms Andrea Head
  • Dr Su Brailsford
  • Ms Charlotte Silver
  • Dr Chris Callaghan
  • Dr Gail Miflin
  • Professor Jean Manson
  • Dr Lynn Manson
  • Professor Mike Murphy
  • Professor Peter Simmonds
  • Dr Rachel Hilton
  • Mr Roger Graham
  • Dr Stephen Thomas
  • Professor Will Irving
  • Professor Yacoub Khalaf
  • Professor Marc Turner
  • Professor Richard Fordham

Secretariat

  • Dr Gary Mallinson

SaBTO has extended the memberships of 5 existing committee members for an additional one year.

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