title: Performance of an antigen assay for diagnosing acute hepatitis E virus genotype 3 infection.
abstract: Hepatitis E virus (HEV) is a major cause of hepatitis worldwide. Its diagnosis is based on the detection of anti-HEV IgM and/or HEV-RNA.
  
  
  
  To evaluate the performance of the Wantaï HEV-antigen (Ag) ELISA(Plus) assay for diagnosing acute HEV infections.
  
  
  
  Specificity was assessed using 100 blood samples containing no anti-HEV IgM, anti-HEV IgG, or HEV-RNA. Cross reactivity was assessed using samples positive for hepatitis C virus RNA (n=10), Epstein-Barr virus DNA (n=10) and cytomegalovirus DNA (n=10). Serial dilutions of 4 HEV RNA positive samples were used to estimate the corresponding viremia detected with the Ag assay. Blood samples from 33 immunocompetent and 31 immunocompromised patients with an acute HEV genotype 3 infection, HEV-RNA positive, were tested to assess diagnostic sensitivity.
  
  
  
  The HEV-Ag assay was 100% specific, with no cross-reactivity. The lower viremias detected ranged from 10(3)copies/ml to 10(5)copies/ml (800-80,000UI/ml). Diagnostic sensitivity for an acute HEV infection was 91%, with no significant difference between immunocompetent (88%) and immunocompromised (94%) patients. The HEV-Ag assay was more frequently positive in immunocompromised patients at the acute phase (94%) than was the anti-HEV IgM test (71%; p=0.04). The HEV-Ag assay ratio was correlated with HEV-RNA viral load (ρ=0.54; p<0.0001).
  
  
  
  The HEV-Ag assay performed well and could be suitable for laboratories with no molecular diagnosic facilities.
authors.affiliation: CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, National Reference Center for Hepatitis E, F-31300, France.
authors.forename: Pauline
authors.initials: P
authors.lastname: Trémeaux
authors.affiliation: CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, National Reference Center for Hepatitis E, F-31300, France; INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse, F-31300, France.
authors.forename: Sébastien
authors.initials: S
authors.lastname: Lhomme
authors.affiliation: CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, National Reference Center for Hepatitis E, F-31300, France; INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse, F-31300, France.
authors.forename: Sabine
authors.initials: S
authors.lastname: Chapuy-Regaud
authors.affiliation: CHU Toulouse, Hôpital Purpan, Département de Gastroentérologie, F-31300, France.
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Peron
authors.affiliation: CHU Toulouse, Hôpital Purpan, Service de Médecine Interne, F-31300, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Alric
authors.affiliation: CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, National Reference Center for Hepatitis E, F-31300, France; CHU Toulouse, Hôpital Rangueil, Département de Néphrologie, Dialyse et Transplantation multi-organe, F-31300, France.
authors.forename: Nassim
authors.initials: N
authors.lastname: Kamar
authors.affiliation: CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, National Reference Center for Hepatitis E, F-31300, France; INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse, F-31300, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Izopet
authors.affiliation: CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, National Reference Center for Hepatitis E, F-31300, France; INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse, F-31300, France. Electronic address: abravanel.f@chu-toulouse.fr.
authors.forename: Florence
authors.initials: F
authors.lastname: Abravanel
mesh_terms: D000956:Antigens, Viral / Q000097:blood*; D003429:Cross Reactions; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D005838:Genotype; D016751:Hepatitis E / Q000175:diagnosis* / Q000821:virology; D016752:Hepatitis E virus / Q000145:classification* / Q000235:genetics*; D006801:Humans; D008297:Male; D012680:Sensitivity and Specificity
chemical_list: D000956:Antigens, Viral
keywords: HEV-antigen; Hepatitis E virus; Immunocompetent patients; Immunocompromised patients