Immunogenicity and Setting Cut Points

Types of Screening Cut Points• Dynamic Cut Point: –• a cut point that changes between the plates ina run, between runs in a study, or betweenstudies, and does not use the variationestimates from pre-study validation.• The latter characteristic differentiates it from afloating cut point.• This Not approach advisable necessary - only only if needed when thevariability between sample results from eachrun is significantly different between assayruns.• A practically limiting factor is that a significantnumber of samples are needed in eachplate/run to compute this cut point.24