Immunogenicity and Setting Cut Points

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Distribution <strong>and</strong> OutliersRun 1 Log ODRun 2 Log ODRun 3 Log ODRun 4 Log ODRun 5 Log ODRun 6 Log OD000-0.5-1-1.5-2-2.50-0.5-1-0.5-1-1.50-0.5-1-1.50-0.5-1-0.5-1-1.5-3-1.5-2-2-1.5-3.5-2Shapiro-Wilk W TestProb
Distribution <strong>and</strong> OutliersRun 1 Log ODRun 2 Log ODRun 3 Log OD-0.4-0.25-0.4-0.6-0.8-1-1.2-1.4-1.6-1.8-0.5-0.75-1-1.25-1.5-0.6-0.8-1-1.2-1.4-1.6With outliers excludedall runs normally distributed-2-1.75-1.8MeanStd DevStd Err Meanupper 95% Meanlow er 95% MeanN-1.3212850.29610640.0441409-1.232325-1.41024645MeanStd DevStd Err Meanupper 95% Meanlow er 95% MeanN-1.1287590.282750.0421499-1.043811-1.21370645MeanStd DevStd Err Meanupper 95% Meanlow er 95% MeanN-1.1243970.26583710.0396287-1.044531-1.20426345Shapiro-Wilk W TestW0.963326Prob
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 and 26: Screening CP Evaluation Flow-Scheme
Page 27: Distribution & OutliersOriginal Dat
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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