Immunogenicity and Setting Cut Points

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Confirmatory <strong>Cut</strong> Point%Inhibition100*1Signal of sample with Inhibitor (s)Signal of unspiked sample (us)504403.5%Inhibition30after log tranf.32.5202101.5100.5• Subjective thresholds (e.g., 50% inhib.) have been proposedbefore.• Shankar et al (2008) proposed an objective thresholdbased on biological & analytical variability.44
Confirmation <strong>Cut</strong> PointexampleAll Data Exclude sample 15log of ratiolog of ratio-0.25 -0.2 -0.15 -0.1 -0.05 0 0.05 0.1-0.5 -0.4 -0.3 -0.2 -0.1 0 0.1 0.2 0.3 0.4Normal(-0.0548,0.05604)Shapiro-Wilk W TestW Prob
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 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: Confirmation Cut PointexampleIndivi
Page 47 and 48: Acknowledgements• Wendell Smith,

Immunogenicity and Setting Cut Points

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