Background: For infectious disease risk assessment among deceased organ donors, pre-donation clinical, microbiological, and behavioral information are reviewed; however, uncertainty may arise due to false negative screening results of recently acquired infections. Method: The burden of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV), and residual risks (RR) of undetected virus was estimated, with the impact of more sensitive screening. Results: For United Kingdom potential deceased organ donors between 2010 and 2014, prevalence of HBsAg was 0.1%, HIV 0.06% and HCV 0.9%, increasing to 25.7% in people who injected drugs (PWID). Incidence, derived from new blood donors, was multiplied by duration of screening assay window periods to give RR per 100 000 donors as 0.43 (95% confidence interval [CI] 0.03-3.99) for HBV, 0.08 (95% CI 0.02-0.21) for HIV, and 5.96 (95% CI 0.82-37.89) for HCV. For PWID, HCV RR was 163.3 (95% CI 22.8-1107.8) compared to 2.76 (95% CI 0.35-17.36) for non-PWID. RR decreased significantly with nucleic acid testing (NAT), and, for HCV, antigen testing had a similar impact. Conclusion: While the burden of HCV risk lies within PWID, these are in small numbers therefore few HCV antigen or NAT tests would be needed to more accurately assess risk.
Bibliographical noteFunding Information:
Thanks to Dr Jonathan Graves, Dr Gary Mallinson, and Dr Charles Newstead of the Advisory Committee on the Safety of Blood Tissues and Organs Donor/Organ Risk Assessment Working Group (SaBTO's DORA), and Dr Patricia Hewitt, NHS Blood and Transplant, for their helpful comments on the manuscript. Thanks also to Dr Nick Andrews and Dr Tom Nicholls, Public Health England, for statistical guidance.
© 2019 Crown copyright. Transplant Infectious Disease © 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd This article is published with the permission of the Controller of HMSO and the Queen's Printer for Scotland.
- informed consent
- residual risk