title: Diagnostic Performance of Five Assays for Anti-Hepatitis E Virus IgG and IgM in a Large Cohort Study.
abstract: Determination of anti-hepatitis E virus (anti-HEV) antibodies is still enigmatic. There is no gold standard, and results obtained with different assays often diverge. Herein, five assays were compared for detection of anti-HEV IgM and IgG. Serum samples from 500 Swedish blood donors and 316 patients, of whom 136 had suspected HEV infection, were analyzed. Concordant results for IgM and IgG with all assays were obtained only for 71% and 70% of patients with suspected hepatitis E, respectively. The range of sensitivity for anti-HEV detection was broad (42% to 96%); this was reflected in the detection limit, which varied up to 19-fold for IgM and 17-fold for IgG between assays. HEV RNA was analyzed in all patients and in those blood donors reactive for anti-HEV in any assay, and it was found in 26 individuals. Among all of the assays, both anti-HEV IgG and IgM were detected in 10 of those individuals. Twelve had only IgG and, in 7 of those 12, IgG was only detected with the two most sensitive assays. Three of the HEV-RNA-positive samples were negative for anti-HEV IgM and IgG in all assays. With the two most sensitive assays, anti-HEV IgG was identified in 16% of the blood donor samples and in 66% of patients with suspected HEV infection. Because several HEV-RNA-positive samples had only anti-HEV IgG without anti-HEV IgM or lacked anti-HEV antibodies, analysis for HEV RNA may be warranted as a complement in the laboratory diagnosis of ongoing HEV infection.
authors.affiliation: Department of Infectious Medicine, Institute of Biomedicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden helene.norder@gu.se.
authors.forename: Heléne
authors.initials: H
authors.lastname: Norder
authors.affiliation: Department of Infectious Medicine, Institute of Biomedicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
authors.forename: Marie
authors.initials: M
authors.lastname: Karlsson
authors.affiliation: Clinic of Infectious Diseases, Södra Älvsborgs Hospital, Borås, Sweden.
authors.forename: Åsa
authors.initials: Å
authors.lastname: Mellgren
authors.affiliation: Department of Transfusion Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.
authors.forename: Jan
authors.initials: J
authors.lastname: Konar
authors.affiliation: Department of Infectious Medicine, Institute of Biomedicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Sandberg
authors.affiliation: Department of Internal Medicine, Södra Älvsborgs Hospital, Borås, Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Lasson
authors.affiliation: Transplant Institute, Sahlgrenska University Hospital and Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
authors.forename: Maria
authors.initials: M
authors.lastname: Castedal
authors.affiliation: Ulf Lundahl Foundation, Stockholm, Sweden.
authors.forename: Lars
authors.initials: L
authors.lastname: Magnius
authors.affiliation: Department of Infectious Medicine, Institute of Biomedicine at Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
authors.forename: Martin
authors.initials: M
authors.lastname: Lagging
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001782:Blood Donors; D015331:Cohort Studies; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005260:Female; D006508:Hepatitis Antibodies / Q000097:blood*; D016751:Hepatitis E / Q000175:diagnosis*; D016752:Hepatitis E virus / Q000276:immunology*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007074:Immunoglobulin G / Q000097:blood*; D007075:Immunoglobulin M / Q000097:blood*; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D006508:Hepatitis Antibodies; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D012367:RNA, Viral