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Multilaboratory comparison of Streptococcus pneumoniae opsonophagocytic killing assays and their level of agreement for the determination of functional antibody activity in human reference sera.


ABSTRACT: Antibody-mediated killing of Streptococcus pneumoniae (pneumococcus) by phagocytes is an important mechanism of protection of the human host against pneumococcal infections. Measurement of opsonophagocytic antibodies by use of a standardized opsonophagocytic assay (OPA) is important for the evaluation of candidate vaccines and required for the licensure of new pneumococcal conjugate vaccine formulations. We assessed agreement among six laboratories that used their own optimized OPAs on a panel of 16 human reference sera for 13 pneumococcal serotypes. Consensus titers, estimated using an analysis-of-variance (ANOVA) mixed-effects model, provided a common reference for assessing agreement among these laboratories. Agreement was evaluated in terms of assay accuracy, reproducibility, repeatability, precision, and bias. We also reviewed four acceptance criterion intervals for assessing the comparability of protocols when assaying the same reference sera. The precision, accuracy, and concordance results among laboratories and the consensus titers revealed acceptable agreement. The results of this study indicate that the bioassays evaluated in this study are robust, and the resultant OPA values are reproducible for the determination of functional antibody titers specific to 13 pneumococcal serotypes when performed by laboratories using highly standardized but not identical assays. The statistical methodologies employed in this study may serve as a template for evaluating future multilaboratory studies.

SUBMITTER: Rose CE 

PROVIDER: S-EPMC3019776 | biostudies-literature | 2011 Jan

REPOSITORIES: biostudies-literature

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Multilaboratory comparison of Streptococcus pneumoniae opsonophagocytic killing assays and their level of agreement for the determination of functional antibody activity in human reference sera.

Rose Charles E CE   Romero-Steiner Sandra S   Burton Robert L RL   Carlone George M GM   Goldblatt David D   Nahm Moon H MH   Ashton Lindsey L   Haston Mitch M   Ekström Nina N   Haikala Raili R   Käyhty Helena H   Henckaerts Isabelle I   Durant Nathalie N   Poolman Jan T JT   Fernsten Phil P   Yu Xinhong X   Hu Branda T BT   Jansen Kathrin U KU   Blake Milan M   Simonetti Elles R ER   Hermans Peter W M PW   Plikaytis Brian D BD  

Clinical and vaccine immunology : CVI 20101117 1


Antibody-mediated killing of Streptococcus pneumoniae (pneumococcus) by phagocytes is an important mechanism of protection of the human host against pneumococcal infections. Measurement of opsonophagocytic antibodies by use of a standardized opsonophagocytic assay (OPA) is important for the evaluation of candidate vaccines and required for the licensure of new pneumococcal conjugate vaccine formulations. We assessed agreement among six laboratories that used their own optimized OPAs on a panel o  ...[more]

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