This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Reprints and Permissions Copyright Information Books from ASM Press MicrobeWorld Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Quataert, S. A. Articles by Madore, D. V. Search for Related Content PubMed PubMed Citation Articles by Quataert, S. A. Articles by Madore, D. V.

 Previous Article  |  Next Article 

Clinical and Diagnostic Laboratory Immunology, November 2004, p. 1064-1069, Vol. 11, No. 6
1071-412X/04/$08.00+0     DOI: 10.1128/CDLI.11.6.1064-1069.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Assignment of Weight-Based Antibody Units for 13 Serotypes to a Human Antipneumococcal Standard Reference Serum, Lot 89-S(F)

Sally A. Quataert,¹ Kate Rittenhouse-Olson,² Carol S. Kirch,¹ Branda Hu,^1* Shelley Secor,¹ Nancy Strong,¹ and Dace V. Madore¹

Wyeth Vaccines Research, Rochester,¹ Departments of Biotechnical and Clinical Laboratory Sciences and Microbiology, The University at Buffalo, State University of New York, Buffalo, New York²

Received 26 April 2004/ Returned for modification 8 June 2004/ Accepted 18 August 2004

Weight-based immunoglobulin G (IgG), IgM, IgA, and total Ig antibody assignments were made to human antipneumococcal standard reference serum lot 89-S, also known as lot 89-SF, for Streptococcus pneumoniae capsular polysaccharide (PnPs) serotypes 2, 6A, 8, 9N, 10A, 11A, 12F, 15B, 19A, 17F, 20, 22F, and 33F, as well as for C-polysaccharide (C-Ps), extending the standard's usefulness for pneumococcal vaccine evaluation beyond the original serotype 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F assignments (S. A. Quataert, C. S. Kirch, L. J. Quackenbush Wiedl, D. C. Phipps, S. Strohmeyer, C. O. Cimino, J. Skuse, and D. V. Madore, Clin. Diagn. Lab. Immunol. 2:590-597, 1995). The additional 14 assignments were determined using an equivalence of absorbance method with an anti-PnPs serotype 6B reference enzyme-linked immunosorbent assay (EIA). To assure accuracy, anti-PnPs EIA for serotype 14 antibodies, a previously assigned serotype, was performed concurrently. This method assures consistency of the new microgram-per-microliter assignments with previous antiserotype assignments to lot 89-S. The sum of the experimentally derived isotype assignments for anti-PnPs serotypes in lot 89-S agrees well with the separately determined total Ig assignment for each serotype. The lot 89-S assignments for serotypes 1, 5, 6B, 14, 18C, 19F, and 23F were used for pneumococcal conjugate vaccine clinical trial evaluation and to generate data in efficacy trials where serological correlates for protection have been proposed. The assignment of antibody concentrations to additional pneumococcal serotypes in this reference reagent facilitates the consistent and accurate comparison of serum antibody concentrations across clinical trials.

---

* Corresponding author. Mailing address: Wyeth Vaccines Research, 401 N. Middletown Rd., 180/152A, Pearl River, NY 10965. Phone: (845) 602-3389. Fax: (845) 602-1885. E-mail: hubt{at}wyeth.com.

---

Clinical and Diagnostic Laboratory Immunology, November 2004, p. 1064-1069, Vol. 11, No. 6
1071-412X/04/$08.00+0     DOI: 10.1128/CDLI.11.6.1064-1069.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

This article has been cited by other articles:

• Sikkema, D. J., Ziembiec, N. A., Jones, T. R., Hildreth, S. W., Madore, D. V., Quataert, S. A. (2005). Assignment of Weight-Based Immunoglobulin G1 (IgG1) and IgG2 Units in Antipneumococcal Reference Serum Lot 89-S(F) for Pneumococcal Polysaccharide Serotypes 1, 4, 5, 7F, 9V, and 18C. CVI 12: 218-223 [Abstract] [Full Text]