“…Furthermore, immunoassays for screening and confirming ADAs can be conducted using a variety of formats and detection systems, each of which has relative strengths and weaknesses (Table 1; Figure 1) [11,27,28]. While there is no single assay format suitable for assessing the immunogenicity of all biologics, regardless of the method selected, all assays must be thoroughly validated according to parameters that include cut-point, sensitivity, specificity, selectivity, precision, dilution linearity and limit of drug tolerance (see Table 2 for definitions) [26,28,[31][32][33][34]. However, because human ADAs are of limited availability, international reference sera/standards for immunoassay validation and calibration are generally unattainable, with the exception of the Table 2.…”