Survey on testing strategies for hepatitis B virus in blood, and tissues and cell donors within the EU/EEA

Background

On 13 June 2024, the new Regulation on standards of quality and safety for substances of human origin (SoHO) intended for human application (EU) 2024/1938 was published. The European Centre for Disease Prevention and Control (ECDC) was designated as the expert institution for the communicable diseases field and assigned to draft guidelines on the prevention of transmission of hepatitis B virus (HBV) through SoHO. On 1 June 2026, ECDC published ‘Guidelines on the prevention of hepatitis B virus transmission through substances of human origin’, covering blood and blood components, tissues and non-reproductive cells, and reproductive cells. To assess the donor testing landscape for HBV prior to the publication of the guidelines, ECDC developed surveys to collect information on current HBV testing practice for SoHO donors across the European Union/European Economic Area (EU/EEA). The results of these surveys are shared in this report.

Methods

In the third quarter of 2024, an online survey was distributed to national focal points (NFP) for blood, tissues and non-reproductive cells, and reproductive cells, to gather information on the national donor testing strategies for HBV, including testing algorithms and laboratory testing methods.

Results

The number of countries responding to the survey ranged from 19 countries for tissues and non-reproductive cells and reproductive cells to 25 countries for blood. In addition to the serological tests mandated by the Directive 2002/98/EC and the Directive 2004/23/EC, HBV DNA nucleic acid amplification tests (NAT) are mandatory or recommended in 88%, 58% and 37% of the participating countries for donors of blood and blood components, tissues and non-reproductive cells, and reproductive cells, respectively. 

In the blood field, either by law or national recommendation, HBV DNA NAT is performed on individual donations in 52% of countries. Less than 50% of countries reported having a required limit of detection. About half (52%) of the countries perform additional anti-HBc testing for blood donors, either at each donation or only in new donors. When considering the use of HBV DNA NAT as an additional measure to enable the quarantine of donations to be waived, the proportion of countries applying NAT increases to 89% for the tissues and non-reproductive cells and 68% for reproductive cells.

Conclusion

Next to the mandatory serological tests, HBV DNA NAT is currently included in, or complements the SoHO donor testing strategy in most participating countries, for the different SoHO. The survey showed considerable heterogeneity among EU/EEA countries regarding testing SoHO donors for HBV. Future assessments will allow ECDC and EU/EEA countries to understand the impact of the ECDC guidelines on the donor testing strategies for HBV in the EU/EEA.