Immunogenicity and Setting Cut Points
Immunogenicity and Setting Cut Points
Immunogenicity and Setting Cut Points
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Fixed or Floating <strong>Cut</strong> Point?Compare run means using mixed effects ANOVA.• On untransformed or log-transformed data, depending onwhichever is more symmetric.• With Runs as fixed effect, Subject as r<strong>and</strong>om effectsCompare run variances using Bartlett‟s or Levene‟s test (orsimilar method).If run means <strong>and</strong> variances are similar, use Fixed cut point.If run means are different, use Floating cut point.If run variances are different, compare the runs from eachanalyst or instrument used in the design, <strong>and</strong> investigateother potential analytical issues with the assay.32
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