title: Antigen quantification as in vitro alternative for potency testing of inactivated viral poultry vaccines.
abstract: Routine batch control of licensed inactivated viral vaccines for poultry usually includes a potency assay as a measure of vaccine efficacy. Potency assays often consist of vaccination-challenge experiments in the target species or in laboratory animals. Instead of measuring the protection of vaccinated animals against virulent pathogens, the serological response after vaccination can be quantified for some vaccines. In vitro antigen quantification assays would be attractive alternatives for the current potency assays because the time and costs involved could be greatly reduced and animal use could be avoided. Such in vitro assays will only be acceptable when the correlation between results and efficacy or potency has been demonstrated convincingly. The results of our studies on antigen quantification assays indicate that, in principle, quantification of viral antigens from inactivated oil-adjuvanted vaccines is feasible and reproducible using specially developed antigen capture ELISAs in combination with specific software for statistical analysis of the ELISA data. We have developed methods to quantify the haemagglutination-neuraminidase (HN) and fusion (F) proteins of Newcastle disease virus (NDV), the viral protein 3 (VP3) of the infectious bursal disease virus (IBDV), and the spike-1 (S1) protein of the infectious bronchitis virus (IBV). Vaccination experiments with inactivated ND vaccines indicate that the in vitro quantified HN- or F-proteins of NDV are reliable indicators of the serological response after vaccination.
authors.affiliation: ID-Lelystad, Department of State Quality Control and Standardization, The Netherlands. h.a.maas@id.wag-ur.nl
authors.forename: R A
authors.initials: RA
authors.lastname: Maas
authors.forename: M P
authors.initials: MP
authors.lastname: de Winter
authors.forename: S
authors.initials: S
authors.lastname: Venema
authors.forename: H L
authors.initials: HL
authors.lastname: Oei
authors.forename: I J
authors.initials: IJ
authors.lastname: Claassen
mesh_terms: D000818:Animals; D000956:Antigens, Viral / Q000032:analysis*; D004306:Dose-Response Relationship, Immunologic; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods / Q000662:veterinary; D015707:HN Protein / Q000032:analysis / Q000276:immunology; D001351:Infectious bronchitis virus / Q000276:immunology*; D007243:Infectious bursal disease virus / Q000276:immunology*; D009522:Newcastle disease virus / Q000201:enzymology / Q000276:immunology*; D011200:Poultry; D011201:Poultry Diseases / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D012680:Sensitivity and Specificity; D013047:Specific Pathogen-Free Organisms; D013997:Time Factors; D015164:Vaccines, Inactivated / Q000276:immunology / Q000592:standards; D014760:Viral Fusion Proteins / Q000032:analysis / Q000276:immunology; D014765:Viral Vaccines / Q000276:immunology / Q000592:standards*
chemical_list: D000956:Antigens, Viral; D015707:HN Protein; D015164:Vaccines, Inactivated; D014760:Viral Fusion Proteins; D014765:Viral Vaccines