title: Multicenter comparison of levels of antibody to the Neisseria meningitidis group A capsular polysaccharide measured by using an enzyme-linked immunosorbent assay.
abstract: There is no standard immunoassay for evaluating immune responses to meningococcal vaccines. We developed an enzyme-linked immunosorbent assay to measure total levels of antibody to Neisseria meningitidis group A capsular polysaccharide. Five laboratories measured the antibody levels in six paired pre- and postvaccination serum samples by using the enzyme-linked immunosorbent assay. Methylated human serum albumin was used to bind native group A polysaccharide to microtiter plate surfaces. The between-laboratory coefficients of variation for pre- and postvaccination sera had ranges of 31 to 91 and 17 to 31, respectively. The mean laboratory coefficients of variation for pre- and postvaccination sera, respectively, were 17 and 11 (Molecular Biology Laboratory, Centers for Disease Control), 12 and 15 (Immunodiagnostic Methods Laboratory, Centers for Disease Control), 22 and 19 (Dana-Farber Cancer Institute), 38 and 38 (Bacterial Polysaccharide Laboratory, U.S. Food and Drug Administration), and 11 and 10 (Praxis Biologics, Inc.). Standardization of this enzyme-linked immunosorbent assay should allow interlaboratory comparison of meningococcal vaccine immunogenicity, thus providing a laboratory-based assessment tool for evaluating meningococcal vaccines.
authors.affiliation: Menigitis and Special Pathogens Branch, Centers for Disease Control, Atlanta, Georgia 30333.
authors.forename: G M
authors.initials: GM
authors.lastname: Carlone
authors.forename: C E
authors.initials: CE
authors.lastname: Frasch
authors.forename: G R
authors.initials: GR
authors.lastname: Siber
authors.forename: S
authors.initials: S
authors.lastname: Quataert
authors.forename: L L
authors.initials: LL
authors.lastname: Gheesling
authors.forename: S H
authors.initials: SH
authors.lastname: Turner
authors.forename: B D
authors.initials: BD
authors.lastname: Plikaytis
authors.forename: L O
authors.initials: LO
authors.lastname: Helsel
authors.forename: W E
authors.initials: WE
authors.lastname: DeWitt
authors.forename: W F
authors.initials: WF
authors.lastname: Bibb
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000096:biosynthesis / Q000737:chemistry*; D000942:Antigens, Bacterial / Q000276:immunology*; D001666:Binding Sites, Antibody; D001667:Binding, Competitive; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D006801:Humans; D015337:Multicenter Studies as Topic; D009345:Neisseria meningitidis / Q000276:immunology*; D011135:Polysaccharides, Bacterial / Q000276:immunology*
chemical_list: D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D011135:Polysaccharides, Bacterial; C043226:meningococcal group A polysaccharide