特異性：Based on the approach used in calculating the assay cut-off value of anti-drug antibody (ADA) ELISAs, approximately 1-5% of tested samples are expected to generate false-positive ADA response during initial screening analysis. Therefore, further confirmation of the specificity of the ADA activity in the samples, identified as positive, is highly recommended. This is supported also by recent publications. In order to confirm the specificity of the ADA signal, a confirmatory assay (competitive drug inhibition test) is proposed by ImmunoGuide. The confirmatory assay is performed with the Confirmatory Reagent (coded IG-CR112). This Confirmatory Reagent is available as a separate product and can be obtained from ImmunoGuide upon request.
