title: Evaluation of two VIDAS®prototypes for detecting anti-HEV IgG.
abstract: High performance anti-hepatitis E virus (HEV) IgG assays are crucial for epidemiology.
  
  
  
  To evaluate the performance of 2 prototypes developed for the VIDAS®automatic system for detecting anti-HEV IgG, one based on the ORF2 antigen (ORF2 prototype) and the other on the ORF2 and ORF3 antigens (ORF2/3 prototype), with reference to the Wantai anti-HEV IgG assay.
  
  
  
  The sensitivity of each assay was determined by testing 113 blood samples, 63 from immunocompetent and 50 from immunocompromised patients, with a proven HEV infection defined by detecting HEV RNA. Their specificity was assessed with 103 blood samples that the Wantai assay indicated was negative for anti-HEV IgM and IgG, and negative for HEV-RNA. Cross reactivity was assessed using samples that were positive for hepatitis A virus IgG (n=16), hepatitis C virus antibodies (n=15), hepatitis B virus antigen and anti-HBc antibodies (n=16), rheumatoid factor (n=14), and negative for anti-HEV IgG with the Wantai assay.
  
  
  
  The sensitivities in immunocompetent patients were: 95.2% (ORF2), 96.8% (ORF2/3), and 93.6% (Wantai); in immunocompromised patients they were: 66% (ORF2), 72% (ORF2/3), and 68% (Wantai). Both VIDAS prototypes detected low concentrations of anti-HEV IgG. The overall specificity was 100% (ORF2 prototype) and 98.1% (ORF2/3 prototype). Both VIDAS prototypes cross-reacted in five samples (9.6%), mainly those containing HCV antibodies or rheumatoid factor.
  
  
  
  Both VIDAS®prototypes performed very well and appear to be suitable for routine detection of anti-HEV IgG.
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
authors.affiliation: R&D Immunoassay Department, Biomérieux SA, Chemin de l'Orme, Marcy l'étoile, France.
authors.forename: Nadège
authors.initials: N
authors.lastname: Goutagny
authors.affiliation: R&D Immunoassay Department, Biomérieux SA, Chemin de l'Orme, Marcy l'étoile, France.
authors.forename: Corinne
authors.initials: C
authors.lastname: Perret
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.
authors.forename: Françoise
authors.initials: F
authors.lastname: Vischi
authors.affiliation: CHU Toulouse, Hôpital Purpan, Laboratoire de virologie, National Reference Center for Hepatitis E, F-31300, France.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Aversenq
authors.affiliation: R&D Immunoassay Department, Biomérieux SA, Chemin de l'Orme, Marcy l'étoile, France.
authors.forename: Aude
authors.initials: A
authors.lastname: Chapel
authors.affiliation: R&D Immunoassay Department, Biomérieux SA, Chemin de l'Orme, Marcy l'étoile, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Dehainault
authors.affiliation: R&D Immunoassay Department, Biomérieux SA, Chemin de l'Orme, Marcy l'étoile, France.
authors.forename: Nadia
authors.initials: N
authors.lastname: Piga
authors.affiliation: R&D Immunoassay Department, Biomérieux SA, Chemin de l'Orme, Marcy l'étoile, France.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Dupret-Carruel
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
mesh_terms: D057205:Automation, Laboratory / Q000379:methods; D006508:Hepatitis Antibodies / Q000097:blood*; D016751:Hepatitis E / Q000175:diagnosis*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007074:Immunoglobulin G / Q000097:blood; D012680:Sensitivity and Specificity
chemical_list: D006508:Hepatitis Antibodies; D007074:Immunoglobulin G
keywords: Anti-HEV IgG; Hepatitis E Virus; Prototypes; VIDAS