Immunogenicity and Setting Cut Points

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Balanced DesignValidation Serum SamplesAnalyst Assay Run Assay PlateP1R1P2P3P1A1R2P2P3P1R3P2P3P1R4P2P3P1A2R5P2P3P1R6P2P3S1-S17 S18-S34 S35-S51XXXXXXXXXXXXXXXXXX18
Balanced Design – includesinhibitorValidation Serum SamplesAnalystAssayRunAssayPlateS1-S17S1-S17plusinhibitorS18-S34S18-S34plusinhibitorS35-S51S35-S51plusinhibitorP1 X XR1P2 X XP3 X XP1XA1R2P2XP3XP1XR3P2XP3XP1 X XR4P2 X XP3 X XP1XA2R5P2XP3XP1XR6P2P3XX19
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: Balanced Design for ValidationExper
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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