title: New immunoassays for total, IgA and IgM antibodies against hepatitis E virus: Prevalence in Italian blood donors and patients with chronic liver or kidney diseases.
abstract: BACKGROUND
  Hepatitis E virus (HEV) is a zoonotic agent that causes acute hepatitis in humans with sporadic infections and outbreaks in developing countries worldwide. The global spread of HEV remains underestimated because of subclinical infections and lack of sensitive diagnostic assays.
  
  
  OBJECTIVE
  To study the prevalence of HEV antibodies (anti-HEV) in sera of blood-donors and patients with chronic-liver-disease and chronic-renal-disease, using newly developed anti-HEV assays.
  
  
  METHODS
  396 sera from 199 blood-donors, 109 chronic-liver-disease patients and 88 chronic-renal-disease patients and three standard reference serum panels were tested in parallel with a sensitive reference anti-HEV assay and newly developed assays for IgA, IgM and total anti-HEV based on HEV-like-particles produced by recombinant baculo-viruses.
  
  
  RESULTS
  Overall, total anti-HEV was detected in 12.9% (7.0% blood-donors, 9.2% and 30.7% chronic-liver-disease patients and chronic-renal-disease patients, respectively). We observed a higher anti-HEV prevalence in older subjects and in chronic-renal-disease patients in relation with degree on immune-depression (p<0.001). Results from reference serum panels showed an optimal and slightly better performance of the new assay over the commercially available assay.
  
  
  CONCLUSIONS
  Newly developed anti-HEV assays using recombinant HEV-like-particles showed optimal diagnostic performances assessing that HEV-infection is endemic in Italy with seroprevalence ranging from 7% to 30% in blood donors and immune-compromised hosts, respectively.
authors.affiliation: Hepatology Unit, University Hospital of Pisa, Pisa, Italy.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Ricco
authors.affiliation: General Medicine 2 Unit and Gastroenterology Chair, University Hospital of Pisa, Italy.
authors.forename: Ferruccio
authors.initials: F
authors.lastname: Bonino
authors.affiliation: Blood Bank Unit, University Hospital of Pisa, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Lanza
authors.affiliation: Blood Bank Unit, University Hospital of Pisa, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Scatena
authors.affiliation: Nephrology, Dialysis and Kidney Transplantation Unit, Foundation IRCCS "Cà Granda Ospedale Maggiore" Policlinic of Milan, Milan, Italy.
authors.forename: Carlo M
authors.initials: CM
authors.lastname: Alfieri
authors.affiliation: Nephrology, Dialysis and Kidney Transplantation Unit, Foundation IRCCS "Cà Granda Ospedale Maggiore" Policlinic of Milan, Milan, Italy.
authors.forename: Piergiorgio
authors.initials: P
authors.lastname: Messa
authors.affiliation: Dia.Pro, Diagnostic Bioprobes, Sesto San Giovanni, Milan, Italy.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Marchisio
authors.affiliation: Dia.Pro, Diagnostic Bioprobes, Sesto San Giovanni, Milan, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Mascolo
authors.affiliation: Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.
authors.forename: Luisa
authors.initials: L
authors.lastname: Romanò
authors.affiliation: Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Galli
authors.affiliation: Department of Virology II, National Institute of Infectious Diseases, Musashi-Murayama, Tokyo, Japan.
authors.forename: Tian-Cheng
authors.initials: TC
authors.lastname: Li
authors.affiliation: Department of Virology II, National Institute of Infectious Diseases, Musashi-Murayama, Tokyo, Japan.
authors.forename: Takaji
authors.initials: T
authors.lastname: Wakita
authors.affiliation: Department of Virology II, National Institute of Infectious Diseases, Musashi-Murayama, Tokyo, Japan.
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Miyamura
authors.affiliation: Hepatology Unit, University Hospital of Pisa, Pisa, Italy. Electronic address: brunettomaurizia@gmail.com.
authors.forename: Maurizia R
authors.initials: MR
authors.lastname: Brunetto
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000914:Antibodies, Viral / Q000097:blood*; D001782:Blood Donors / Q000706:statistics & numerical data; D002908:Chronic Disease; D005260:Female; D016751:Hepatitis E / Q000097:blood* / Q000453:epidemiology*; D016752:Hepatitis E virus / Q000276:immunology*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007070:Immunoglobulin A / Q000097:blood; D007075:Immunoglobulin M / Q000097:blood; D007558:Italy / Q000453:epidemiology; D008107:Liver Diseases / Q000097:blood; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D051436:Renal Insufficiency, Chronic / Q000097:blood; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007070:Immunoglobulin A; D007075:Immunoglobulin M
keywords: Assay; Epidemiology; HEV; Virus-Like Particles (V-LPs)