title: Quantitation of poliovirus antigens in inactivated viral vaccines by enzyme-linked immunosorbent assay using animal sera and monoclonal antibodies.
abstract: Recent advances in methods for the manufacture of inactivated poliovirus vaccines have resulted in increased vaccine immunogenicity. In conjunction with this capability it is important to have available highly sensitive and quantitative potency assays. The potential suitability of enzyme-linked immunoassay (ELISA) was evaluated using animal sera with neutralizing antibodies or neutralizing monoclonal antibodies for antigen detection in potency tests. The monoclonal antibodies developed, which bound D antigen but not C antigen, were neutralizing unless relatively weakly reactive. Those that bound C antigen only were non-neutralizing. Those that bound both C and D antigens were sometimes neutralizing. D-specific and D/C-specific neutralizing monoclonal antibodies against type-2 poliovirus protected mice on passive immunization against paralytic disease and death from the MEF strain virus. Potency measurements by ELISA using either D-specific neutralizing monoclonal antibodies or type-specific goat sera for antigen detection were sensitive and precise. Tests using C-specific monoclonal antibodies for antigen detection indicated that increased C antigen content may result in falsely elevated reactivities of animal sera with some vaccines. Monoclonal antibodies may be useful ELISA reagents for IPV potency testing.
authors.affiliation: Division of Virology, Center for Biologics Evaluation & Research, Food and Drug Administration, Bethesda, Maryland 20892.
authors.forename: C
authors.initials: C
authors.lastname: Singer
authors.forename: F
authors.initials: F
authors.lastname: Knauert
authors.forename: G
authors.initials: G
authors.lastname: Bushar
authors.forename: M
authors.initials: M
authors.lastname: Klutch
authors.forename: R
authors.initials: R
authors.lastname: Lundquist
authors.forename: G V
authors.initials: GV
authors.lastname: Quinnan
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000032:analysis*; D000914:Antibodies, Viral / Q000032:analysis*; D000956:Antigens, Viral / Q000032:analysis*; D004797:Enzyme-Linked Immunosorbent Assay; D006825:Hybridomas; D051379:Mice; D008807:Mice, Inbred BALB C; D009500:Neutralization Tests; D017955:Poliovirus / Q000276:immunology*; D011054:Poliovirus Vaccine, Inactivated / Q000276:immunology*; D011817:Rabbits; D011863:Radioimmunoassay
chemical_list: D000911:Antibodies, Monoclonal; D000914:Antibodies, Viral; D000956:Antigens, Viral; D011054:Poliovirus Vaccine, Inactivated