Compositions, devices, and methods of ibs sensitivity testing
AssigneeBiomerica, Inc.
InventorsELISABETH LADERMAN, ZACKARY IRANI-COHEN
Life of this patent
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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.
Claims21
-98. (canceled)
A test kit for testing food intolerance in patients diagnosed with or suspected to have irritable bowel syndrome, comprising:
- a plurality of distinct food preparations coupled to individually addressable respective solid carriers;
- wherein the plurality of distinct food preparations have an average discriminatory p-value of ≦0.07 as determined by raw p-value or an average discriminatory p-value of ≦0.10 as determined by FDR multiplicity adjusted p-value.
A method of testing food intolerance in patients diagnosed with or suspected to have irritable bowel syndrome, comprising:
- contacting a food preparation with a bodily fluid of a patient that is diagnosed with or suspected to have irritable bowel syndrome, and wherein the bodily fluid is associated with a gender identification;
- wherein the step of contacting is performed under conditions that allow IgG from the bodily fluid to bind to at least one component of the food preparation;
- measuring IgG bound to the at least one component of the food preparation to obtain a signal;
- comparing the signal to a gender-stratified reference value for the food preparation using the gender identification to obtain a result;
- and
- updating or generating a report using the result, wherein the step of contacting a food preparation is performed with a plurality of distinct food preparations.
A method of generating a test for food intolerance in patients diagnosed with or suspected to have irritable bowel syndrome, 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 to have irritable bowel syndrome and bodily fluids of a control group not diagnosed with or not suspected to have irritable bowel syndrome;
- stratifying the test results by gender for each of the distinct food preparations;
- and
- assigning for a predetermined percentile rank a different cutoff value for male and female patients for each of the distinct food preparations.
Dependencies are inferred from the claim text.