The study samples identified as positive at the screening step will be submitted to the confirmatory assay. The confirmatory assay is performed to evaluate whether the ADAs present in the study samples are specific to the biological-drug product thereby antibody specificity. The assay design is similar to the screening assay and as such the study samples are analyzed in the presence and absence of excess biological-drug. A titer is determined to evaluate the relative amount of antibody present in the study samples confirmed positive.

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