Compositions, devices, and methods of crohn's disease sensitivity testing
OwnerZackary Irani-cohen, Elisabeth Ladermaninventors
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Abstract
Contemplated test kits and methods for food sensitivity are based on rational-based selection of food preparations with established discriminatory p-value. Particularly preferred kits include those with a minimum number of food preparations that have an average discriminatory p-value of ≤0.07 as determined by their raw p-value or an average discriminatory p-value of ≤0.10 as determined by FDR multiplicity adjusted p-value. In further contemplated aspects, compositions and methods for food sensitivity are also stratified by gender to further enhance predictive value.
Claims37
A Crohn's Disease test kit panel consisting essentially of:
- a plurality of distinct Crohn's Disease food preparations immobilized to an individually addressable solid carrier;
- wherein the plurality of distinct Crohn's Disease food preparations each have a raw p-value of ≤0.07 or a false discovery rate (FDR) multiplicity adjusted p-value of ≤0.
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A method of testing food sensitivity comprising:
- contacting a test kit panel consisting essentially of a plurality of distinct Crohn's Disease trigger food preparations with a bodily fluid of a patient that is diagnosed with or suspected of having Crohn's Disease;
- wherein the step of contacting is performed under conditions that allow at least a portion of an immunoglobulin from the bodily fluid to bind to at least one component of the plurality of distinct Crohn's Disease trigger food preparations;
- measuring the immunoglobulin bound to the at least one component of the plurality of distinct Crohn's Disease trigger food preparations to obtain a signal;
- and
- updating or generating a report using the signal.
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A method of generating a test for patients diagnosed with or suspected of having Crohn's Disease, comprising:
- obtaining test results for a plurality of distinct food preparations, wherein the test results are based on bodily fluids of patients diagnosed with or suspected of having Crohn's Disease and bodily fluids of a control group not diagnosed with or not suspected of having Crohn's Disease;
- stratifying the test results by gender for each of the distinct food preparations;
- assigning for a predetermined percentile rank a different cutoff value for male and female patients for each of the distinct food preparations;
- selecting a plurality of distinct Crohn's Disease trigger food preparations that each have a raw p-value of ≤0.07 or a FDR multiplicity adjusted p-value of ≤0.10;
- and
- generating a test comprising the selected distinct Crohn's Disease trigger food preparations.
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Dependencies are inferred from the claim text.