Immunogenicity and Setting Cut Points

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Basis of Presentation• Analogies will be used to get everybody on thesame page• A simplified data sets will be used to illustrate theassignment of screening and confirmation cut points.• As we go through the illustration, feel free to posequestions we will capture those and address thoseduring the second presentation or during the 2 ndhour.2
Screening Cut Point• Definition: Assay‟s response level at andabove which a sample is classified to be„potential‟ positive & below which it isdefined to be negative („not detected‟)• Determined statistically from theresponses in a subset of samples that arepresumed to be ADA negative.3
Page 1: Immunogenicity and SettingCut Point
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 and 22: Types of Screening Cut Points• Fi
Page 23 and 24: Types of Screening Cut Points• Dy
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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