Journal of Immunology Research / 2016 / Article / Tab 4

Research Article

Application of a Plug-and-Play Immunogenicity Assay in Cynomolgus Monkey Serum for ADCs at Early Stages of Drug Development

Table 4

Reproducibility of the plug-and-play assay. Assay control precision expressed as the coefficient of variation of the signal observed in 6 independent runs. The negative control is a pooled cynomolgus monkey serum. The positive control is a human IgG-cynomolgus monkey IgG fusion molecule. Interassay precision for signal values obtained with the two controls is summarised below. In addition, a ratio of the signals obtained with the positive and negative controls was calculated for assay performance evaluation.

Assay controlNumber of runsMean measurement (units)CV (%)

Negative control60.169 (AU)16

Positive control60.302 (AU)13
1.80 (ratio)11

Fusion positive control at 125 ng/mL.
AU = absorbance units; CV = coefficient of variation.
Ratio = positive control signal/negative control signal.

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