title: Variability in the performance characteristics of IgG anti-HEV assays and its impact on reliability of seroprevalence rates of hepatitis E.
abstract: Hepatitis E is a major public health problem in developing countries and is increasingly being recognized as a cause of substantial sporadic viral hepatitis infections in industrialized countries. Variable rates of hepatitis E seroprevalence have been reported from the same geographic regions depending on the assay used. In this study, we evaluated the performance characteristics of four assays which included two commercial assays, Wantai HEV-IgG ELISA kit (Wantai, China), and DS-EIA-ANTI-HEV-G kit (DSI, Italy), one NIH-developed immunoassay (NIH-55 K, Kuniholm et al. [2009] Journal of Infectious Diseases 200:48-56), previously used in several major seroprevalence studies and one in-house Western blot assay (CDC-WB). The limit of detection of IgG anti-HEV is 100 mIU/mL for Wantai assay, 200 mIU/mL for CDC-WB assay, 1000 mIU/mL for DSI assay, and 40 mIU/mL for NIH-55 K assay. Pairwise concordance between the four assays ranged from 56% to 87%. The concordance among all four assays was observed in 52% of the samples, while the concordance among three assays was observed in 37% of the samples. These data show a wide discordance between various IgG anti-HEV assays and warrant a comprehensive evaluation of all the assays using well characterized global serum reference panels.
authors.affiliation: Division of Viral Hepatitis, National Center for HIV, Hepatitis, STDs, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Maja
authors.initials: M
authors.lastname: Kodani
authors.affiliation: Division of Viral Hepatitis, National Center for HIV, Hepatitis, STDs, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Nourine A
authors.initials: NA
authors.lastname: Kamili
authors.affiliation: Division of Viral Hepatitis, National Center for HIV, Hepatitis, STDs, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Tejada-Strop
authors.affiliation: Division of Viral Hepatitis, National Center for HIV, Hepatitis, STDs, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Amanda
authors.initials: A
authors.lastname: Poe
authors.affiliation: Division of Viral Hepatitis, National Center for HIV, Hepatitis, STDs, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Maxine M
authors.initials: MM
authors.lastname: Denniston
authors.affiliation: Division of Viral Hepatitis, National Center for HIV, Hepatitis, STDs, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Jan
authors.initials: J
authors.lastname: Drobeniuc
authors.affiliation: Division of Viral Hepatitis, National Center for HIV, Hepatitis, STDs, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Saleem
authors.initials: S
authors.lastname: Kamili
mesh_terms: D006508:Hepatitis Antibodies / Q000097:blood*; D016751:Hepatitis E / Q000175:diagnosis*; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood*; D015203:Reproducibility of Results; D016036:Seroepidemiologic Studies; D012698:Serologic Tests / Q000379:methods*
chemical_list: D006508:Hepatitis Antibodies; D007074:Immunoglobulin G
keywords: IgG anti-HEV; enzyme assays; hepatitis E virus; protein electrophoresis; seroprevalence