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NAb Assays<br />
• The incidence of NAbs is reported in section 6.2<br />
of the label (PLR format). Therefore it is critical<br />
to have a robust validated assay.<br />
• Assay validation:<br />
– Cut-point<br />
–Precision<br />
– Selectivity – matrix interference (patient sera, on<br />
board drug)<br />
– Robustness – sensitivity to changes in operating<br />
parameters (e.g., incubation time/temperature)<br />
– Reproducibility – differences between laboratories.<br />
This is only necessary if the assay will be performed<br />
in more than one laboratory
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