Therapeutic Product Immunogenicity Community

Hi All,

For ADA studies where in-study cut-points are needed following pre-study validation, should the in-study cut-points be applied retrospectively to assess both plate positive control (PC) acceptance and sample results? Or if the pre-study validation cut-points should continue to be applied to assess plate control PCs (plate acceptance criteria) while applying in-study cut-points to study samples only?

Thanks,

Zahir

Hi Zahir, 

I would recommend to with second option where validation cut point should be used for plate acceptance and in study cut point should be used for samples. I am assuming your PCs were prepared in normal healthy individual matrix and the validation cut point was also established in Normal Healthy individual matrix. 

In general, use the cut point based on the matrix of sample/PC. 

Hi All,

For ADA studies where in-study cut-points are needed following pre-study validation, should the in-study cut-points be applied retrospectively to assess both plate positive control (PC) acceptance and sample results? Or if the pre-study validation cut-points should continue to be applied to assess plate control PCs (plate acceptance criteria) while applying in-study cut-points to study samples only?

Thanks,

Zahir