JCM Figure table search 04
Home Help [Feedback] [For Subscribers] [Archive] [Search] [Contents]
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrowReprints and Permissions
Right arrow Copyright Information
Right arrow Books from ASM Press
Right arrow MicrobeWorld
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Plikaytis, B. D.
Right arrow Articles by Carlone, G. M.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Plikaytis, B. D.
Right arrow Articles by Carlone, G. M.

Journal of Clinical Microbiology, June 2000, p. 2043-2050, Vol. 38, No. 6
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

An Analytical Model Applied to a Multicenter Pneumococcal Enzyme-Linked Immunosorbent Assay Study

Brian D. Plikaytis,1,* David Goldblatt,2 Carl E. Frasch,3 Christine Blondeau,4 Michael J. Bybel,5 G. Scott Giebink,6 Ingileif Jonsdottir,7 Helena Käyhty,8 Helle Bossen Konradsen,9 Dace V. Madore,10 Moon H. Nahm,11 Cheryl A. Schulman,12 Patricia F. Holder,1 Tamar Lezhava,13 Cheryl M. Elie,1 and George M. Carlone1

Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention,1 and Rollins School of Public Health, Emory University,13 Atlanta, Georgia; Immunobiology Unit, Institute of Child Health, University College London, London, England2; Division of Bacterial Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland3; Pasteur Mérieux Connaught, Clinical Sero-Immunology Laboratory, Val de Reuil, France4; Pasteur Mérieux Connaught, Clinical Serology, Swiftwater, Pennsylvania5; Department of Pediatrics, University of Minnesota, Minneapolis, Minnesota6; National University Hospital, Department of Immunology, Reykjavik, Iceland7; National Public Health Institute, Helsinki, Finland8; Statens Serum Institut, Division of Microbiology, Copenhagen, Denmark9; Wyeth-Lederle Vaccines and Pediatrics, West Henrietta, New York10; University of Rochester, School of Medicine, Rochester, New York11; and Merck Research Laboratories, Developmental Human Vaccine Serology, West Point, Pennsylvania12

Received 8 October 1999/Returned for modification 1 December 1999/Accepted 9 March 2000

Pneumococcal conjugate vaccines will eventually be licensed after favorable results from phase III efficacy trials. After licensure of a conjugate vaccine for invasive pneumococcal disease in infants, new conjugate vaccines will likely be licensed primarily on the basis of immunogenicity data rather than clinical efficacy. Analytical methods must therefore be developed, evaluated, and validated to compare immunogenicity results accurately within and between laboratories for different vaccines. At present no analytical technique is uniformly accepted and used in vaccine evaluation studies to determine the acceptable level of agreement between a laboratory result and the assigned value for a given serum sample. This multicenter study describes the magnitude of agreement among 12 laboratories quantifying an identical series of 48 pneumococcal serum specimens from 24 individuals (quality-control sera) by a consensus immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) developed for this study. After provisional or trial antibody concentrations were assigned to the quality-control serum samples for this study, four methods for comparison of a series of laboratory-determined values with the assigned concentrations were evaluated. The percent error between assigned values and laboratory-determined concentrations proved to be the most informative of the four methods. We present guidelines that a laboratory may follow to analyze a series of quality-control sera to determine if it can reproduce the assigned antibody concentrations within an acceptable level of tolerance. While this study focused on a pneumococcal IgG ELISA, the methods that we describe are easily generalizable to other immunological assays.

* Corresponding author. Mailing address: Division of Bacterial and Mycotic Diseases/NCID, Mailstop C09, Centers for Disease Control and Prevention, Atlanta, GA 30333. Phone: (404) 639-4711. Fax: (404) 639-2780. E-mail: bdp1{at}cdc.gov.

Journal of Clinical Microbiology, June 2000, p. 2043-2050, Vol. 38, No. 6
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


This article has been cited by other articles:



Home Help [Feedback] [For Subscribers] [Archive] [Search] [Contents]
Antimicrob. Agents Chemother. Clin. Microbiol. Rev.
Clin. Vaccine Immunol. ALL ASM JOURNALS

Copyright © 2000 by the American Society for Microbiology. All rights reserved.