1887

Abstract

Introduction. Although hepatitis E virus (HEV) is mainly transmitted via the faecal–oral route, the rate of HEV transmission via blood donation is on the rise. However, the seroprevalence of HEV among blood donors is not well established and is thought to be affected by the type of diagnostic assay used. We aimed to evaluate performance and correlation among widely used commercial diagnostic assays for the seroprevalence assessment of HEV-IgM/IgG among blood donors.

Methodology. A total of 1049 blood donor samples were tested for HEV IgG and IgM using different enzyme immunoassays (Wantai, Eruoimmune, MP diagnostics, Mikrogen immunoblot, HEV-IgM rapid test). The performance of each assay was evaluated according to our established silver standard value based on three or more IgG concordant assay results.

Results. HEV seroprevalence varied considerably using these assays, ranging from 10.1 % (Euroimmune-ELISA) to 18.0 % (Wanti-ELISA) for HEV-IgG, and from 0.2 % (Wanti-ELISA) to 2.6 % (MP Rapid test) for HEV-IgM. A total of 155 of 216 (71.6%) samples tested positive for HEV-IgG by three or more concordant assays. On the other hand, IgM assays showed poor agreement as only 7.6 % (4/52) of the specimens were positive according to three or more concordant assay test results. All HEV-IgG assays revealed high sensitivity and specificity (ranging 96.5–100 %),and excellent Kappa concordance (0.88–0.95), except for Euroimmun ELISA (sensitivity=61.5 %, kappa=0.63). MP ELISA showed the highest levels of sensitivity (100 %) and specificity (98.5 %).

Conclusions. Due to discrepancies in the performance of various IgG and IgM assays, seroprevalence studies should be based on furher confirmatory testing for decisive conclusions to be reached.

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2018-07-27
2024-03-29
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References

  1. WHO 2016; Hepatitis E. www.who.int/mediacentre/factsheets/fs280/en/ accessed 2016
  2. Emerson SU, Clemente-Casares P, Moiduddin N, Arankalle VA, Torian U et al. Putative neutralization epitopes and broad cross-genotype neutralization of Hepatitis E virus confirmed by a quantitative cell-culture assay. J Gen Virol 2006; 87:697–704 [View Article][PubMed]
    [Google Scholar]
  3. Engle RE, Yu C, Emerson SU, Meng XJ, Purcell RH. Hepatitis E virus (HEV) capsid antigens derived from viruses of human and swine origin are equally efficient for detecting anti-HEV by enzyme immunoassay. J Clin Microbiol 2002; 40:4576–4580 [View Article][PubMed]
    [Google Scholar]
  4. Al-Sadeq DW, Majdalawieh AF, Nasrallah GK. Seroprevalence and incidence of hepatitis E virus among blood donors: A review. Rev Med Virol 2017e1937 [View Article][PubMed]
    [Google Scholar]
  5. Aggarwal R. Diagnosis of hepatitis E. Nat Rev Gastroenterol Hepatol 2013; 10:24–33 [View Article][PubMed]
    [Google Scholar]
  6. Taherkhani R, Farshadpour F. Epidemiology of hepatitis E in pregnant women and children in Iran: a general overview. J Clin Transl Hepatol 2016; 4:269–276 [View Article][PubMed]
    [Google Scholar]
  7. Marano G, Vaglio S, Pupella S, Facco G, Bianchi M et al. Hepatitis E: an old infection with new implications. Blood Transfus 2015; 13:6–17 [View Article][PubMed]
    [Google Scholar]
  8. Taherkhani R, Farshadpour F. A new strategy for development of hepatitis E vaccine: epitope-based vaccines. Pathogen & Infectious Disease 2015
    [Google Scholar]
  9. Boxall E, Herborn A, Kochethu G, Pratt G, Adams D et al. Transfusion-transmitted hepatitis E in a 'nonhyperendemic' country. Transfus Med 2006; 16:79–83 [View Article][PubMed]
    [Google Scholar]
  10. Colson P, Coze C, Gallian P, Henry M, De Micco P et al. Transfusion-associated hepatitis E, France. Emerg Infect Dis 2007; 13:648–649 [View Article][PubMed]
    [Google Scholar]
  11. Khuroo MS, Kamili S, Yattoo GN. Hepatitis E virus infection may be transmitted through blood transfusions in an endemic area. J Gastroenterol Hepatol 2004; 19:778–784 [View Article][PubMed]
    [Google Scholar]
  12. Matsubayashi K, Kang JH, Sakata H, Takahashi K, Shindo M et al. A case of transfusion-transmitted hepatitis E caused by blood from a donor infected with hepatitis E virus via zoonotic food-borne route. Transfusion 2008; 48:1368–1375 [View Article][PubMed]
    [Google Scholar]
  13. Matsubayashi K, Nagaoka Y, Sakata H, Sato S, Fukai K et al. Transfusion-transmitted hepatitis E caused by apparently indigenous hepatitis E virus strain in Hokkaido, Japan. Transfusion 2004; 44:934–940 [View Article][PubMed]
    [Google Scholar]
  14. Mitsui T, Tsukamoto Y, Yamazaki C, Masuko K, Tsuda F et al. Prevalence of hepatitis E virus infection among hemodialysis patients in Japan: evidence for infection with a genotype 3 HEV by blood transfusion. J Med Virol 2004; 74:563–572 [View Article][PubMed]
    [Google Scholar]
  15. Tamura A, Shimizu YK, Tanaka T, Kuroda K, Arakawa Y et al. Persistent infection of hepatitis E virus transmitted by blood transfusion in a patient with T-cell lymphoma. Hepatol Res 2007; 37:113–120 [View Article][PubMed]
    [Google Scholar]
  16. Nasrallah GK, Al Absi ES, Ghandour R, Ali NH, Taleb S et al. Seroprevalence of hepatitis E virus among blood donors in Qatar (2013-2016). Transfusion 2017; 57:1801–1807 [View Article][PubMed]
    [Google Scholar]
  17. Purcell RH, Emerson SU. Hepatitis E: an emerging awareness of an old disease. J Hepatol 2008; 48:494–503 [View Article][PubMed]
    [Google Scholar]
  18. Féray C, Pawlotsky JM, Roque-Afonso AM, Samuel D, Dhumeaux D. Should we screen blood products for hepatitis E virus RNA?. Lancet 2014; 383:218 [View Article][PubMed]
    [Google Scholar]
  19. Al-Sadeq DW, Majdalawieh AF, Mesleh AG, Abdalla OM, Nasrallah GK. Laboratory challenges in the diagnosis of hepatitis E virus. J Med Microbiol 2018466–480 [View Article][PubMed]
    [Google Scholar]
  20. Vollmer T, Knabbe C, Dreier J. Comparison of real-time PCR and antigen assays for detection of hepatitis E virus in blood donors. J Clin Microbiol 2014; 52:2150–2156 [View Article][PubMed]
    [Google Scholar]
  21. Gupta E, Pandey P, Pandey S, Sharma MK, Sarin SK. Role of hepatitis E virus antigen in confirming active viral replication in patients with acute viral hepatitis E infection. J Clin Virol 2013; 58:374–377 [View Article][PubMed]
    [Google Scholar]
  22. Kohn MA, Carpenter CR, Newman TB. Understanding the direction of bias in studies of diagnostic test accuracy. Acad Emerg Med 2013; 20:1194–1206 [View Article][PubMed]
    [Google Scholar]
  23. Pischke S, Behrendt P, Bock CT, Jilg W, Manns MP et al. Hepatitis E in Germany - an under-reported infectious disease. Dtsch Arztebl Int 2014; 111:577–583 [View Article][PubMed]
    [Google Scholar]
  24. Faber MS, Wenzel JJ, Jilg W, Thamm M, Höhle M et al. Hepatitis E virus seroprevalence among adults, Germany. Emerg Infect Dis 2012; 18:1654–1657 [View Article][PubMed]
    [Google Scholar]
  25. Wenzel JJ, Sichler M, Schemmerer M, Behrens G, Leitzmann MF et al. Decline in hepatitis E virus antibody prevalence in southeastern Germany, 1996-2011. Hepatology 2014; 60:1180–1186 [View Article][PubMed]
    [Google Scholar]
  26. Pas SD, Streefkerk RH, Pronk M, de Man RA, Beersma MF et al. Diagnostic performance of selected commercial HEV IgM and IgG ELISAs for immunocompromised and immunocompetent patients. J Clin Virol 2013; 58:629–634 [View Article][PubMed]
    [Google Scholar]
  27. Park HK, Jeong SH, Kim JW, Woo BH, Lee DH et al. Seroprevalence of anti-hepatitis E virus (HEV) in a Korean population: comparison of two commercial anti-HEV assays. BMC Infect Dis 2012; 12:142 [View Article][PubMed]
    [Google Scholar]
  28. Avellon A, Morago L, Garcia-Galera del Carmen M, Munoz M, Echevarría JM. Comparative sensitivity of commercial tests for hepatitis E genotype 3 virus antibody detection. J Med Virol 2015; 87:1934–1939 [View Article][PubMed]
    [Google Scholar]
  29. Al-Qahtani AA, Alabsi ES, Abuodeh R, Thalib L, El Zowalaty ME et al. Prevalence of anelloviruses (TTV, TTMDV, and TTMV) in healthy blood donors and in patients infected with HBV or HCV in Qatar. Virol J 2016; 13:208 [View Article][PubMed]
    [Google Scholar]
  30. Amimo JO, El Zowalaty ME, Githae D, Wamalwa M, Djikeng A et al. Metagenomic analysis demonstrates the diversity of the fecal virome in asymptomatic pigs in East Africa. Arch Virol 2016; 161:887–897 [View Article][PubMed]
    [Google Scholar]
  31. Abuodeh RO, Al-Absi E, Ali NH, Khalili M, Al-Mawlawi N et al. Detection and phylogenetic analysis of human pegivirus (GBV-C) among blood donors and patients infected with hepatitis B virus (HBV) in Qatar. J Med Virol 2015; 87:2074–2081 [View Article][PubMed]
    [Google Scholar]
  32. Abuodeh R, Al-Mawlawi N, Al-Qahtani AA, Bohol MF, Al-Ahdal MN et al. Detection and genotyping of torque teno virus (TTV) in healthy blood donors and patients infected with HBV or HCV in Qatar. J Med Virol 2015; 87:1184–1191 [View Article][PubMed]
    [Google Scholar]
  33. Smatti MK, Yassine HM, Abuodeh R, Almarawani A, Taleb SA et al. Prevalence and molecular profiling of Epstein Barr virus (EBV) among healthy blood donors from different nationalities in Qatar. PLoS One 2017; 12:e0189033 [View Article][PubMed]
    [Google Scholar]
  34. Abravanel F, Chapuy-Regaud S, Lhomme S, Dubois M, Peron JM et al. Performance of two commercial assays for detecting hepatitis E virus RNA in acute or chronic infections. J Clin Microbiol 2013; 51:1913–1916 [View Article][PubMed]
    [Google Scholar]
  35. Staquet M, Rozencweig M, Lee YJ, Muggia FM. Methodology for the assessment of new dichotomous diagnostic tests. J Chronic Dis 1981; 34:599–610 [View Article][PubMed]
    [Google Scholar]
  36. Cao D, Meng XJ. Molecular biology and replication of hepatitis E virus. Emerg Microbes Infect 2012; 1:e17 [View Article][PubMed]
    [Google Scholar]
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