title: Characterization of reference materials for human antiserum to pertussis antigens by an international collaborative study.
abstract: Enzyme-linked immunosorbent assay (ELISA) has been widely used to evaluate antibody responses to pertussis vaccination and infection. A common reference serum is essential for the standardization of these assays. However, no internationally recognized reference serum is available. At the request of the Expert Committee on Biological Standardization (ECBS) of the World Health Organization (WHO), a set of four candidate international standards has been prepared. These candidate materials have been assessed for suitability and compared to the widely used U.S. reference pertussis antiserum (human) lot 3, lot 4, and lot 5 by 22 laboratories from 15 countries in an international collaborative study. Laboratories measured immunoglobulin G (IgG) and IgA antibodies to pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae (Fim2&3) using their established immunoassays. The results of this study showed each of the four candidates to be suitable as an international standard. With the agreement of the participants, a recommendation has been made to the ECBS that the candidate material coded 06/140 be established as the First International Standard for pertussis antiserum (human), with the following assigned international units (IU): IgG anti-PT, 335 IU/ampoule; IgA anti-PT, 65 IU/ampoule; IgG anti-FHA, 130 IU/ampoule; IgA anti-FHA, 65 IU/ampoule; IgG anti-PRN, 65 IU/ampoule; and IgA anti-PRN, 42 IU/ampoule. No formal units have been proposed for anti-Fim2&3 because most assays used a mixture of fimbrial antigens. In addition, the candidate material coded 06/142 has been proposed as a WHO working preparation for characterization of assay systems.
authors.affiliation: National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, United Kingdom. dxing@nibsc.ac.uk
authors.forename: Dorothy
authors.initials: D
authors.lastname: Xing
authors.forename: Carl Heinz
authors.initials: CH
authors.lastname: Wirsing von König
authors.forename: Penny
authors.initials: P
authors.lastname: Newland
authors.forename: Marion
authors.initials: M
authors.lastname: Riffelmann
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Meade
authors.forename: Michael
authors.initials: M
authors.lastname: Corbel
authors.forename: Rose
authors.initials: R
authors.lastname: Gaines-Das
mesh_terms: D018829:Adhesins, Bacterial / Q000276:immunology; D000907:Antibodies, Bacterial / Q000097:blood*; D000942:Antigens, Bacterial / Q000276:immunology; D019411:Clinical Laboratory Techniques / Q000592:standards*; D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards; D036781:Fimbriae Proteins / Q000276:immunology; D006801:Humans; D007106:Immune Sera / Q000276:immunology*; D007070:Immunoglobulin A / Q000097:blood*; D007074:Immunoglobulin G / Q000097:blood*; D037342:Pertussis Toxin / Q000276:immunology; D010567:Pertussis Vaccine / Q000276:immunology*; D012015:Reference Standards; D010566:Virulence Factors, Bordetella / Q000276:immunology; D014917:Whooping Cough / Q000276:immunology*
chemical_list: D018829:Adhesins, Bacterial; D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D007106:Immune Sera; D007070:Immunoglobulin A; D007074:Immunoglobulin G; D010567:Pertussis Vaccine; D010566:Virulence Factors, Bordetella; C065273:filamentous hemagglutinin adhesin, Bordetella pertussis; C101541:fim2 protein, Bordetella; C101542:fim3 protein, Bordetella; D036781:Fimbriae Proteins; D037342:Pertussis Toxin