Immunogenicity and Setting Cut Points

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Types of Screening Cut Points• Floating cut point: –• Is calculated by multiplying a specificnormalization factor, determined fromthe pre-study validation data, to thebiological background obtained duringthe in-study phase.• Alternatively, biological backgroundvalues can be added to thenormalization factor if logtransformation was not necessary in theanalysis.22
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 approach is necessary only 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.23
Page 1 and 2: Immunogenicity and SettingCut Point
Page 3 and 4: Screening Cut Point• Definition:
Page 8 and 9: But 5% of the time we hit something
Page 11 and 12: Upper BalconiesHigh PCMiddle Balcon
Page 13 and 14: Upper BalconiesHigh PCMiddle Balcon
Page 15 and 16: Assay Background has 2 VariationCom
Page 17 and 18: Balanced Design for ValidationExper
Page 19 and 20: Balanced Design - includesinhibitor
Page 21: Types of Screening Cut Points• Fi
Page 25 and 26: Screening CP Evaluation Flow-Scheme
Page 27 and 28: Distribution & OutliersOriginal Dat
Page 29 and 30: Distribution and OutliersRun 1 Log
Page 31 and 32: How the SD should be calculate?•
Page 33 and 34: Fixed or Floating?Log OD-1-21 2 3 4
Page 35 and 36: Floating Cut PointAdditive or Multi
Page 37 and 38: Switches and Balls• The specific
Page 39 and 40: Non-specific inhibition asrepresent
Page 41 and 42: Setting LimitsLowPositiveControlLar
Page 43 and 44: Confirmation Cut PointexampleIndivi
Page 45 and 46: Confirmation Cut PointexampleAll Da
Page 47 and 48: Acknowledgements• Wendell Smith,

Immunogenicity and Setting Cut Points

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