Survey on testing strategies for hepatitis C 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 [1]. The European Centre for Disease Prevention and Control (ECDC) was designated as the expert institution for this field of communicable diseases and assigned to draft guidelines on the prevention of hepatitis C virus (HCV) transmission through SoHO. On 1 June 2026, ECDC published ‘Guidelines on the prevention of hepatitis C 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 HCV prior to the publication of ECDC guidelines, ECDC developed surveys to collect information on current HCV testing practices 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 HCV, including testing algorithms and laboratory testing methods.

Results

The number of countries that responded to the survey ranged from 18 countries for 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, HCV ribonucleic acid (RNA) nucleic acid amplification tests (NAT) are mandatory or recommended in 96%, 58% and 50% of the participating countries for donors of blood, tissues and non-reproductive cells, and reproductive cells, respectively.

In the blood field, either by law or national recommendation, HCV RNA NATs are performed on individual donations in 52% of the countries. Less than 50% of countries reported having a required limit of detection. When considering the use of HCV RNA NAT as an additional measure to enable the quarantine of donations to be waived, the proportion of countries applying NAT increases to 66% of responding countries in the reproductive cells field.

The use of HCV antigen (Ag) testing is infrequent in the different SoHO fields and no countries reported using anti-HCV/HCV Ag tests.

Conclusion

In addition to the mandatory serological test, HCV RNA NAT is currently included in, or serves as a complement to the SoHO donor testing strategy in most participating countries, for the various SoHO. The survey showed limited
heterogeneity among EU/EEA countries regarding the testing of SoHO donors for HCV. Future assessments will allow ECDC and the EU/EEA countries to understand the impact of ECDC guidelines on the donor testing strategies
for HCV in the EU/EEA.