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.
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.
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