Surveillance Open Access
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Awareness of transfusion-transmitted hepatitis E raised in recent years led to the mandatory testing of blood donations in some European countries for hepatitis E virus (HEV) RNA. However, little is known about the epidemiology of HEV infections.


To and describe and analyse the epidemiology of HEV infections in blood donors in Germany.


Data from routine testing of therapeutic blood products donated between January 2015 and December 2022 at the Uni.Blutspendedienst OWL were analysed at the Institute of Laboratory and Transfusion Medicine, Heart and Diabetes Centre North Rhine-Westphalia. A total of 731,630 allogenic blood donations from 119,610 individual blood donors were tested for HEV RNA in minipools of 96 samples. The HEV RNA-positive donations were analysed for the presence of anti-HEV IgM and IgG. The HEV strains were genotyped and various clinical liver-specific parameters were determined.


A total of 497 HEV-positive blood donations were identified, resulting in a yearly incidence of 1:1,474, from which 78.4% of the donations were RNA-only positive. Increased alanine aminotransferase activity was determined in 26.6% of HEV RNA-positive donors and was associated with the detection of IgG antibodies (1.2% anti-HEV IgM-positive, 11.9% anti-HEV IgM- and IgG-positive and 8.5% anti-HEV IgG-positive). An average incidence of 0.084–0.083% HEV RNA-positive donations in June and July in all years was observed, and a higher proportion of HEV RNA-positive men compared with women. All isolated HEV sequences corresponded to genotype 3.


Our results underline the necessity of HEV RNA screening in blood donations.


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  1. Poggensee G, Benzler J, Eckmanns T, Krause G. Falldefinitionen für die Surveillance meldepflichtiger Infektionskrankheiten in Deutschland, Ausgabe 2007. [On the 2007 edition of case definitions for the surveillance of notifiable infectious diseases in Germany]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2006;49(12):1189-94. German.  https://doi.org/10.1007/s00103-006-0088-3  https://doi.org/10.1007/s00103-006-0088-3  PMID: 17149664 
  2. Faber M, Willrich N, Schemmerer M, Rauh C, Kuhnert R, Stark K, et al. Hepatitis E virus seroprevalence, seroincidence and seroreversion in the German adult population. J Viral Hepat. 2018;25(6):752-8.  https://doi.org/10.1111/jvh.12868  PMID: 29377436 
  3. Horvatits T, Schulze Zur Wiesch J, Lütgehetmann M, Lohse AW, Pischke S. The clinical perspective on hepatitis E. Viruses. 2019;11(7):617.  https://doi.org/10.3390/v11070617  PMID: 31284447 
  4. Kamar N, Bendall R, Legrand-Abravanel F, Xia N-S, Ijaz S, Izopet J, et al. Hepatitis E. Lancet. 2012;379(9835):2477-88.  https://doi.org/10.1016/S0140-6736(11)61849-7  PMID: 22549046 
  5. Dreier J, Knabbe C, Vollmer T. Transfusion-transmitted hepatitis E: NAT screening of blood donations and infectious dose. Front Med (Lausanne). 2018;5:5. . Available from: https://www.frontiersin.org/articles/10.3389/fmed.2018.00005 https://doi.org/10.3389/fmed.2018.00005  PMID: 29450199 
  6. Westhölter D, Hiller J, Denzer U, Polywka S, Ayuk F, Rybczynski M, et al. HEV-positive blood donations represent a relevant infection risk for immunosuppressed recipients. J Hepatol. 2018;69(1):36-42.  https://doi.org/10.1016/j.jhep.2018.02.031  PMID: 29551705 
  7. Healy K, Freij U, Ellerstad M, Aulin LBS, Brückle L, Hillmering H, et al. Evaluating the prevalence of Hepatitis E virus infection in a large cohort of European blood donors, 2015-2018. J Viral Hepat. 2022;29(9):835-9.  https://doi.org/10.1111/jvh.13682  PMID: 35499211 
  8. Boland F, Martinez A, Pomeroy L, O’Flaherty N. Blood Donor Screening for Hepatitis E Virus in the European Union. Transfus Med Hemother. 2019;46(2):95-103.  https://doi.org/10.1159/000499121  PMID: 31191195 
  9. Federal Gazette (Bundesanzeiger). Bekanntmachungüber die Zulassung von Arzneimitteln– Abwehr von Arzneimittelrisiken –Anordnung der Testung von Blutspendernzur Verhinderung einer Übertragung von Hepatitis-E-Virusdurch Blutkomponenten zur Transfusion und Stammzellzubereitungenzur hämatopoetischen Rekonstitution [Announcement on the authorisation of medicinal products - Defence against drug risks - Order to test blood donors to prevent the transmission of hepatitis E virus through blood components for transfusion and stem cell preparations for haematopoietic reconstitution]. Langen: Paul Ehrlich Institute and Federal Institute for Vaccines and Biomedical Drugs; 5 Feb 2019. German. Available from: https://www.bundesanzeiger.de/pub/publication/8ziFMqlkUHaYCwHxuin?0
  10. Al-Sadeq DW, Majdalawieh AF, Nasrallah GK. Seroprevalence and incidence of hepatitis E virus among blood donors: A review. Rev Med Virol. 2017;27(5):e1937.  https://doi.org/10.1002/rmv.1937  PMID: 28876496 
  11. Mättö J, Putkuri N, Rimhanen-Finne R, Laurila P, Clancy J, Ihalainen J, et al. Hepatitis E virus in Finland: epidemiology and risk in blood donors and in the general population. Pathogens. 2023;12(3):484.  https://doi.org/10.3390/pathogens12030484  PMID: 36986406 
  12. Harvala H, Hewitt PE, Reynolds C, Pearson C, Haywood B, Tettmar KI, et al. Hepatitis E virus in blood donors in England, 2016 to 2017: from selective to universal screening. Euro Surveill. 2019;24(10):1800386.  https://doi.org/10.2807/1560-7917.ES.2019.24.10.1800386  PMID: 30862338 
  13. Laperche S, Maugard C, Lhomme S, Lecam S, Ricard C, Dupont I, et al. Seven years (2015-2021) of blood donor screening for HEV-RNA in France: lessons and perspectives. Blood Transfus. 2023;21(2):110-8.  PMID: 35969132 
  14. Bes M, Costafreda MI, Riveiro-Barciela M, Piron M, Rico A, Quer J, et al. Effect of Hepatitis E virus RNA universal blood donor screening, Catalonia, Spain, 2017‒2020. Emerg Infect Dis. 2022;28(1):157-65.  https://doi.org/10.3201/eid2801.211466  PMID: 34932460 
  15. Vollmer T, Diekmann J, Johne R, Eberhardt M, Knabbe C, Dreier J. Novel approach for detection of hepatitis E virus infection in German blood donors. J Clin Microbiol. 2012;50(8):2708-13.  https://doi.org/10.1128/JCM.01119-12  PMID: 22675127 
  16. Baylis SA, Blümel J, Mizusawa S, Matsubayashi K, Sakata H, Okada Y, et al. World Health Organization International Standard to harmonize assays for detection of hepatitis E virus RNA. Emerg Infect Dis. 2013;19(5):729-35.  https://doi.org/10.3201/eid1905.121845  PMID: 23647659 
  17. Vina-Rodriguez A, Schlosser J, Becher D, Kaden V, Groschup MH, Eiden M. Hepatitis E virus genotype 3 diversity: phylogenetic analysis and presence of subtype 3b in wild boar in Europe. Viruses. 2015;7(5):2704-26.  https://doi.org/10.3390/v7052704  PMID: 26008708 
  18. Dumke J, Hinse D, Vollmer T, Knabbe C, Dreier J. Development and application of a multilocus sequence typing scheme for Streptococcus gallolyticus subsp. gallolyticus. J Clin Microbiol. 2014;52(7):2472-8.  https://doi.org/10.1128/JCM.03329-13  PMID: 24789199 
  19. Sievers F, Higgins DG. Clustal Omega for making accurate alignments of many protein sequences. Protein Sci. 2018;27(1):135-45.  https://doi.org/10.1002/pro.3290  PMID: 28884485 
  20. R Core Team. R: A language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing; 2020. Available from: http://www.Rproject.org/
  21. Henseler O, Heiden M, Haschberger B, Hesse J, Seitz R. Bericht nach § 21 Transfusionsgesetz gemeldeter Daten. [Reports according to Section 21 of the Transfusion Act, TFG]. Langen: Paul-Ehrlich-Institute. [Accessed: 22 Jun 2023]. Available from: https://www.pei.de/DE/newsroom/pflichtberichte/21tfg/21-tfg-berichte-node.html
  22. Tedder RS, Ijaz S, Kitchen A, Ushiro-Lumb I, Tettmar KI, Hewitt P, et al. Hepatitis E risks: pigs or blood-that is the question. Transfusion. 2017;57(2):267-72.  https://doi.org/10.1111/trf.13976  PMID: 28194857 
  23. de Vos AS, Janssen MP, Zaaijer HL, Hogema BM. Cost-effectiveness of the screening of blood donations for hepatitis E virus in the Netherlands. Transfusion. 2017;57(2):258-66.  https://doi.org/10.1111/trf.13978  PMID: 28144956 
  24. Hoad VC, Seed CR, Fryk JJ, Harley R, Flower RLP, Hogema BM, et al. Hepatitis E virus RNA in Australian blood donors: prevalence and risk assessment. Vox Sang. 2017;112(7):614-21.  https://doi.org/10.1111/vox.12559  PMID: 28833229 
  25. Vollmer T, Diekmann J, Knabbe C, Dreier J. Hepatitis E virus blood donor NAT screening: as much as possible or as much as needed? Transfusion. 2019;59(2):612-22.  https://doi.org/10.1111/trf.15058  PMID: 30548866 
  26. Faber M, Askar M, Stark K. Case-control study on risk factors for acute hepatitis E in Germany, 2012 to 2014. Euro Surveill. 2018;23(19):17.  https://doi.org/10.2807/1560-7917.ES.2018.23.19.17-00469  PMID: 29766841 
  27. Zaaijer HL. No artifact, hepatitis E is emerging. Hepatology. 2015;62(2):654.  https://doi.org/10.1002/hep.27611  PMID: 25418372 
  28. Wenzel JJ, Sichler M, Schemmerer M, Behrens G, Leitzmann MF, Jilg W. Decline in hepatitis E virus antibody prevalence in southeastern Germany, 1996-2011. Hepatology. 2014;60(4):1180-6.  https://doi.org/10.1002/hep.27244  PMID: 24912687 
  29. Thom K, Gilhooly P, McGowan K, Malloy K, Jarvis LM, Crossan C, et al. Hepatitis E virus (HEV) in Scotland: evidence of recent increase in viral circulation in humans. Euro Surveill. 2018;23(12):17.  https://doi.org/10.2807/1560-7917.ES.2018.23.12.17-00174  PMID: 29589577 
  30. Golkocheva-Markova E, Ismailova C, Kevorkyan A, Raycheva R, Zhelyazkova S, Kotsev S, et al. Age and Gender Trends in the Prevalence of Markers for Hepatitis E Virus Exposure in the Heterogeneous Bulgarian Population. Life (Basel). 2023;13(6):1345.  https://doi.org/10.3390/life13061345  PMID: 37374127 
  31. Dalton HR, Bendall RP, Rashid M, Ellis V, Ali R, Ramnarace R, et al. Host risk factors and autochthonous hepatitis E infection. Eur J Gastroenterol Hepatol. 2011;23(12):1200-5.  https://doi.org/10.1097/MEG.0b013e32834ca4da  PMID: 21941192 
  32. Ren F, Zhao C, Wang L, Wang Z, Gong X, Song M, et al. Hepatitis E virus seroprevalence and molecular study among blood donors in China. Transfusion. 2014;54(3 Pt 2):910-7.  https://doi.org/10.1111/trf.12530  PMID: 24372259 

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