The European Centre for Disease Prevention and Control has published updated guidelines for screening donated blood, tissues and cells for hepatitis B and C across the EU and EEA, with the aim of reducing the risk of infections being passed to patients during transfusions and transplants.
The guidance applies to substances of human origin — a broad category that includes donated blood, stem cells, reproductive cells and tissue — as well as to medically assisted reproduction, the ECDC said in a statement on Monday.
The guidelines are intended to support the implementation of Regulation (EU) 2024/1938, which sets out rules to prevent communicable diseases being transmitted through donated human material.
Safety standards had previously been shaped by older legislation, leading to varying testing practices across the EU and EEA.
Bruno Ciancio, Head of Unit for Directly Transmitted and Vaccine-Preventable Diseases at ECDC, said the update replaces “outdated and fragmented safety measures” with “evidence-based modern standards for hepatitis B and C virus screening”.
What the guidelines cover
The ECDC said the documents set out harmonised screening strategies for hepatitis B virus (HBV) and hepatitis C virus (HCV) for donations used in transfusion or transplantation.
They include donor deferral periods for people considered at risk, and laboratory screening requirements.
The protocols are designed to detect infections that older testing may have missed, including very early-stage HCV infections and “occult” HBV infections — hepatitis B infections that can be harder to identify with some tests.
National health authorities and organisations that handle donated substances of human origin now have time to adapt their procedures before Regulation (EU) 2024/1938 is enforced in August 2027.
The hepatitis guidance follows ECDC guidelines on HIV published in 2025, and further technical guidance covering additional pathogens is being developed for publication on the agency’s website.
