title: Comparative sensitivity of commercial tests for hepatitis E genotype 3 virus antibody detection.
abstract: Hepatitis E virus (HEV) acute infection is often diagnosed only by anti-HEV IgM ELISA methods, whose sensitivity varies, according to different reports. Reports assessing the specificity of commercial assays for anti-HEV IgG testing are scarce, and estimates of sensitivity and specificity are both controversial. The aim of this work is to assess the sensitivity of different commercial techniques for HEV genotype 3 antibody (anti-HEV) IgM and IgG detection in entirely specific sample panels including both high and low antibody concentrations. The anti-HEV IgM and IgG ELISA methods compared were: DSI, Mikrogen, Wantai, Euroimmun, MP, and Dia.pro. The rapid test All Diag was also included in the anti-HEV IgM comparison. Our results show that low anti-HEV IgM concentrations were better detected by DSI, Mikrogen, and All Diag, these tests being the most sensitive in our study. Euroimmun, MP and Dia.pro gave concordant results, showing lower sensitivity than the others. Regarding anti-HEV IgG our results revealed similar anti-HEV IgG sensitivity. Furthermore, there was a striking overall lack of concordance among the results. We present a thorough review of previous comparative reports, with particular reference to the anti-HEV IgG comparison, since published results differ from ours. This discrepancy may be related to the improved versions of the tests for MP and Dia.pro that we employed.
authors.affiliation: National Centre of Microbiology, Carlos III Health Institute, Hepatitis Unit, Madrid, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Avellon
authors.affiliation: National Centre of Microbiology, Carlos III Health Institute, Hepatitis Unit, Madrid, Spain.
authors.forename: Lucia
authors.initials: L
authors.lastname: Morago
authors.affiliation: National Centre of Microbiology, Carlos III Health Institute, Hepatitis Unit, Madrid, Spain.
authors.forename: Maria
authors.initials: M
authors.lastname: Garcia-Galera del Carmen
authors.affiliation: National Centre of Microbiology, Carlos III Health Institute, Hepatitis Unit, Madrid, Spain.
authors.forename: Milagros
authors.initials: M
authors.lastname: Munoz
authors.affiliation: National Centre of Microbiology, Carlos III Health Institute, Hepatitis Unit, Madrid, Spain.
authors.forename: Jose-Manuel
authors.initials: JM
authors.lastname: Echevarría
mesh_terms: D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005838:Genotype; D006508:Hepatitis Antibodies / Q000097:blood*; D016751:Hepatitis E / Q000175:diagnosis* / Q000821:virology; D016752:Hepatitis E virus / Q000145:classification / Q000235:genetics / Q000276:immunology*; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007075:Immunoglobulin M / Q000097:blood; D012680:Sensitivity and Specificity
chemical_list: D006508:Hepatitis Antibodies; D007074:Immunoglobulin G; D007075:Immunoglobulin M
keywords: HEV; IgG; IgM; anti-HEV; comparative sensitivity