Safer blood, tissues, and cells: ECDC defines unified hepatitis B and C virus screening guidelines for European donations

The new guidelines are the scientific foundation for the prevention of communicable disease transmission to protect recipients of substances of human origin (SoHO) and offspring of medically assisted reproduction, as described by Regulation (EU) 2024/1938. Previously, safety standards were governed by decades-old legislation, which led to outdated and varying testing practices and protocols across the European Union and European Economics Area (EU/EEA). By replacing these, ECDC is creating a modern and uniform safety net for all citizens receiving donor materials, updating the rules and translating the new SoHO Regulation into clinical practice.

'This update is a major step in protecting European citizens,’ said Bruno Ciancio, Head of Unit, Directly Transmitted and Vaccine-Preventable Diseases, ‘We are replacing outdated and fragmented safety measures with evidence-based modern standards for hepatitis B and C virus screening. This will ensure patients get a high level of protection across the continent and reduce the risk of infection from donors.'

Developed with expert input from across Europe, the guidelines define harmonised screening strategies to prevent the transmission of hepatitis B and C viruses through the transfusion or transplantation of donated blood, stem cells, reproductive cells, and tissue. They outline deferral periods for donors at risk and clear laboratory screening requirements. Crucially, the protocols are designed to detect infections that older testing regimes may have missed, such as very early-stage acute HCV infections and hidden (occult) HBV infections.

With the publication of these documents, national health authorities and SoHO establishments now have the time they need to adapt their procedures before Regulation (EU) 2024/1938 is enforced in August 2027.

This follows the release of the HIV guidelines in 2025, marking the next phase in an ongoing rollout of scientific standards from ECDC. Further technical guidance covering additional pathogens is in development and will be published on ECDC’s website.