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Journal of Clinical Microbiology, June 2000, p. 2043-2050, Vol. 38, No. 6
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.
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
*
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.
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