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Background In high-income countries, hepatitis E virus (HEV) infection is mainly a zoonosis. However, it is also transfusion-transmissible and some countries, but not Italy, have introduced HEV screening for blood donations. Aim We assessed HEV infection prevalence and risk factors in a nationwide sample of Italian blood donors. Methods We selected 107 blood establishments (BE) distributed in the 20 Italian regions by a stratified two-stage design and invited them to participate in the study. Donors were tested for anti-HEV IgG and IgM and HEV RNA. Sociodemographic data and risk factors were collected through a questionnaire. Results Overall, 60 BE from 60 provinces in 19 Italian regions joined the study. We assessed HEV markers in 7,172 blood donors, of whom 6,235 completed the questionnaire. Overall crude and adjusted anti-HEV IgG prevalences were 8.3% and 5.5%, respectively. Overall anti-HEV IgM prevalence was 0.5%, while no blood donor was HEV RNA-positive. Anti-HEV IgG prevalence varied widely among regions (range: 1.3%–27.20%) and hyperendemic prevalences (> 40%) were detected in some provinces in two regions. Older age (AOR = 1.81; 95% CI: 1.36–2.41), foreign nationality (AOR = 2.77; 95% CI: 1.06–7.24), eating raw pork liver sausages (AOR = 2.23; 95% CI: 1.55–3.20) and raw homemade sausages (AOR = 3.63; 95% CI: 2.50–5.24) were independent infection predictors. Conclusion Italian blood donors showed a low to moderate HEV seroprevalence. High levels in some regions and/or provinces were mainly attributable to eating habits. Prevention should include avoiding consumption of raw or undercooked meat and safe production of commercial pork products.

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In this study, we demonstrated that the DPX test underestimates the B19V DNA content of the 3rd WHO IS for B19V DNA and that this is not due to an incorrect potency assigned to the standard but, most probably, to a mismatch between the primers/probe and the sequence of the target region in the 3rd WHO IS for B19V DNA.