Immunogenicity and Setting Cut Points

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Cut Point: Distribution & OutliersNeed the distribution to be adequately normal for:• Comparing run mean and variances between runs• Using parametric approach for calculating cut point.Need to remove/down-weigh outliers to ensure thatthe false negative rate applies to the expectedrange of ADA negative response (also, due to riskbased strategy).First, evaluate the distribution of original and logtransformeddata, averaged across runs.• Compare Skewness & Shapiro-Wilks p-values.• Rest of the analysis should then be performed onwhichever scale is most symmetric26
Distribution & OutliersOriginal Data (OD)Log-transformed0 0.2 0.4 0.6 0.8 1 1.2-2 -1.5 -1 -0.5 0Shapiro-Wilk W TestW0.474479Prob
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 and 22: Types of Screening Cut Points• Fi
Page 23 and 24: Types of Screening Cut Points• Dy
Page 25: Screening CP Evaluation Flow-Scheme
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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