title: Development and validation of a new serum standard for the measurement of anti-HEV antibodies in animals.
abstract: Although hepatitis E virus (HEV) infection is a zoonosis, there is, currently, no standardized assay for quantitatively measuring anti-HEV antibody levels in HEV animal reservoirs. In this study, anti-HEV antibody positive serum from a rabbit (RS26) was calibrated by dose-response parallel line assay using the World Health Organization (WHO) reference standard for anti-HEV antibodies. After evaluating the stability of the RS26 serum, a quantification assay of anti-HEV antibodies using RS26 as a standard was developed and evaluated for both reproducibility and suitability to field studies. The anti-HEV antibody level of RS26 was calculated to be 39.54 IU/ml. A series of standard working serum for anti-HEV antibodies consisted of five serum dilutions (3.950 IU/ml, 1.975 IU/ml, 0.986 IU/ml, 0.494 IU/ml, and 0.247 IU/ml). The quantitative assay using RS26 showed good range and reproducibility, effectively measuring the dynamics of anti-HEV antibody concentrations in pigs and rabbits. In conclusion, we have developed a a stable and reproducible serum standard for the quantitation of anti-HEV antibodies. J. Med. Virol. 89:497-501, 2017. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Department of Microbiology and Center of Infectious Disease, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, China.
authors.forename: Yulin
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Department of Microbiology and Center of Infectious Disease, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, China.
authors.forename: Lin
authors.initials: L
authors.lastname: Wang
authors.affiliation: Department of Microbiology and Center of Infectious Disease, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, China.
authors.forename: Hang
authors.initials: H
authors.lastname: Zeng
authors.affiliation: Department of Microbiology and Center of Infectious Disease, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, China.
authors.forename: Wanyun
authors.initials: W
authors.lastname: Gong
authors.affiliation: Department of Microbiology and Center of Infectious Disease, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, China.
authors.forename: Ling
authors.initials: L
authors.lastname: Wang
authors.affiliation: Department of Microbiology and Center of Infectious Disease, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Zhuang
mesh_terms: D000818:Animals; D006508:Hepatitis Antibodies / Q000097:blood*; D016751:Hepatitis E / Q000175:diagnosis / Q000662:veterinary*; D011817:Rabbits; D012015:Reference Standards; D015203:Reproducibility of Results; D012698:Serologic Tests / Q000379:methods* / Q000592:standards*; D044967:Serum / Q000737:chemistry; D013552:Swine
chemical_list: D006508:Hepatitis Antibodies
keywords: ELISA quantitation; HEV; animals; diagnostic test; immune response