title: Poliovirus-binding inhibition ELISA for evaluation of immune response to oral poliovirus vaccine: a possible alternative to the neutralization test.
abstract: This study describes an ELISA variant (Binding Inhibition ELISA, BI ELISA) for the quantitative determination of neutralization-relevant antibodies to polioviruses. The test differs from previously described analogs by utilizing polyclonal immune reagents: capture antibodies and biotin-labeled detecting antibodies. The BI ELISA was compared with the conventional neutralization test (NT) by testing live Sabin and wild-type poliovirus strains. The comparison of 68 serum samples taken from Oral Poliovirus Vaccine (OPV) recipients showed 100% specificity and sensitivity for Sabin 1 and Sabin 2, and 100% sensitivity and 97% specificity for Sabin 3. Good correlations (r = 0.7, 0.77, 0.65 for Sabin 1, 2, 3, respectively) were demonstrated between the NT and BI ELISA results. These results indicate that the BI ELISA can be used as a reliable alternative to the NT for determination of neutralization-relevant antibodies to polioviruses in vaccinees and in large-scale sero-epidemiological studies.
authors.affiliation: Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA. ivanov@cber.fda.gov
authors.forename: A P
authors.initials: AP
authors.lastname: Ivanov
authors.forename: E M
authors.initials: EM
authors.lastname: Dragunsky
authors.forename: O E
authors.initials: OE
authors.lastname: Ivanova
authors.forename: G V
authors.initials: GV
authors.lastname: Rezapkin
authors.forename: S G
authors.initials: SG
authors.lastname: Potapova
authors.forename: K M
authors.initials: KM
authors.lastname: Chumakov
mesh_terms: D000818:Animals; D000914:Antibodies, Viral / Q000032:analysis / Q000096:biosynthesis*; D000956:Antigens, Viral / Q000032:analysis; D001710:Biotin / Q000737:chemistry; D002648:Child; D003429:Cross Reactions; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D006801:Humans; D007106:Immune Sera / Q000737:chemistry / Q000276:immunology; D007074:Immunoglobulin G / Q000276:immunology; D007202:Indicators and Reagents; D008297:Male; D009500:Neutralization Tests; D017955:Poliovirus / Q000276:immunology* / Q000378:metabolism*; D011055:Poliovirus Vaccine, Oral / Q000276:immunology*; D011817:Rabbits
chemical_list: D000914:Antibodies, Viral; D000956:Antigens, Viral; D007106:Immune Sera; D007074:Immunoglobulin G; D007202:Indicators and Reagents; D011055:Poliovirus Vaccine, Oral; D001710:Biotin