关于通过人类源物质预防丙型肝炎病毒传播的指南

Technical guidelines supporting the regulation onstandards of quality and safety for substances ofhuman origin intended for human application ECDCPUBLIC HEALTH GUIDANCE Guidelines on the prevention of hepatitis Cvirus transmission through substances ofhuman origin Technical guidelines supporting the regulation on standards of quality andsafety for substances of human origin intended for human application The content of these guidelines was developed by the European Centre for Disease Prevention and Control (ECDC)with the support of a technical ad hoc scientific panel composed of 17 experts from the EU/EEA countries. The work of the guidelines development was coordinated by the ECDC SoHO team: Flávia Cunha, Francois-XavierLamy and Jenny Mohseni Skoglund. The following internal ECDC experts contributed to the work that informed the guidelines development: FláviaCunha, Francois-Xavier Lamy, Jenny Mohseni Skoglund, Nina Lagerqvist, Erika Duffell, Ndeindo NdeikoundamNgangro, and Csaba Kodmon. We would like to thank the following members of the ECDC ad hoc scientific panel for their insightful input,supporting with evidence, expertise, reviewing the pathogen data sheet and meeting minutes, and providingstatements to the guidelines: •Alessandra Alteri, IRCCS San Raffaele Scientific Institute, Italy•Alexandra Hartmann, Cells and Tissue Bank, Austria•Aliénor Xhaard, Hopital St-Louis, France•Ana Avellón, National Center of Microbiology Carlos III Institute of Health, Spain•Andreas Lind, Oslo University Hospital, Norway•Anna Vilarrodona, Banc de Sang i Teixits, Spain•Anthi Gafou, Hospital of Kifisia ‘Oi Agioi Anargyroi’, Greece•Danica Valkovicová Staneková, Slovak Medical University, Slovakia•Dominique Challine, Henri Mondor Hospital, France•Dragoslav Domanovic, European Blood Alliance, international organisation•Jaana Mättö, University of Helsinki, Finland•Paolo Grossi, ASST-Sette Laghi, Italy•Piotr Grabarczyk, Institute of Haematology and Transfusion Medicine, Poland•Ruth Offergeld, Robert Koch Institute, Germany•Ryanne W Lieshout-Krikke, Sanquin Blood Supply Foundation, Netherlands•Silvia Sauleda, Banc de Sang i Teixits, Spain•Syria Laperche, Etablissement Français du Sang, France We would also like to thank the observers to the expert panel for their valuable input: •Rada Grubovic Rastvorceva, European Directorate for the Quality of Medicines and Healthcare (EDQM)•Jacinto Sanchéz Ibañez, EDQM (delegated) Suggested citation: European Centre for Disease Prevention and Control. Guidelines on the prevention of hepatitisC virus transmission through substances of human origin. Stockholm: ECDC; 2026. Stockholm, June 2026 ISBN 978-92-9498-823-2doi: 10.2900/6503189Catalogue number TQ-01-25-053-EN-N © European Centre for Disease Prevention and Control, 2026 Reproduction is authorised, provided the source is acknowledged Contents Abbreviations ............................................................................................................................................... ivGlossary........................................................................................................................................................1Executive summary ........................................................................................................................................2Key requirements .....................................................................................................................................3Blood and blood components.................................................................................................................3Tissues and non-reproductive cells – living and deceased donors ..............................................................4Reproductive cells – third-party donations...............................................................................................5Reproductive cells – within-relationship use ............................................................................................6Introduction ..................................................................................................................................................7Objectives and scope ................................................................................................................................7Target audience .......................................................................................................................................8Structure of the document.........................................................................................................................8Guidelines development..................................................................................................................................9Overall guidelines development..................................................................................................................9Evidence synthesis........................