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Clinical and Vaccine Immunology, March 2009, p. 303-311, Vol. 16, No. 3
1071-412X/09/$08.00+0     doi:10.1128/CVI.00372-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

Characterization of Reference Materials for Human Antiserum to Pertussis Antigens by an International Collaborative Study {triangledown}

Dorothy Xing,1* Carl Heinz Wirsing von König,2,3 Penny Newland,1 Marion Riffelmann,2,3 Bruce D. Meade,4,{dagger} Michael Corbel,1 and Rose Gaines-Das1

National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, United Kingdom,1 Institut für Infektiologie Krefeld GmbH, D-47805 Krefeld, Germany,2 Institut für Hygiene und Labormedizin, HELIOS Klinikum Krefeld, D-47805 Krefeld, Germany,3 Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852-14484

Received 10 October 2008/ Returned for modification 31 October 2008/ Accepted 19 December 2008

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.

* Corresponding author. Mailing address: National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, United Kingdom. Phone: 44-1707-641000. Fax: 44-1707-641054. E-mail: dxing{at}nibsc.ac.uk

{triangledown} Published ahead of print on 24 December 2008.

{dagger} Present address: Meade Biologics LLC, Hillsborough, NC.

Clinical and Vaccine Immunology, March 2009, p. 303-311, Vol. 16, No. 3
1071-412X/09/$08.00+0     doi:10.1128/CVI.00372-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.





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