![]() For these reasons, comparison of the incidence of antibodies to bivalirudin in the studies described below with the incidence of antibodies in other studies or to other products may be misleading. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. As with all therapeutic proteins, there is potential for immunogenicity.
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