Compositions, devices, and methods of ibs sensitivity testing

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.

1 . A test kit with 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.   
     
     
         2 . The test kit of  claim 1  wherein the plurality of food preparations includes at least two food preparations prepared from food items of Table 1 or selected from a group consisting of cocoa, tea, oat, cabbage, cow milk, onion, honey, rye, corn, yeast, wheat, soybean, egg, tuna, lemon, pineapple, cucumber, orange, halibut, walnut, grapefruit, cane sugar, chicken, blueberry, and shrimp, and optionally from a group consisting of crab, barley, strawberry, pork, rice, beef, cashew, codfish, potato, white Sesame, broccoli, almond, turkey, scallop, and Salmon. 
     
     
         3 .- 5 . (canceled) 
     
     
         6 . The test kit of  claim 1  wherein the plurality of distinct food preparations has an average discriminatory p-value of ≤0.05 as determined by raw p-value or an average discriminatory p-value of ≤0.08 as determined by FDR multiplicity adjusted p-value. 
     
     
         7 .- 9 . (canceled) 
     
     
         10 . The test kit of  claim 1  wherein FDR multiplicity adjusted p-value is adjusted for at least one of age and gender. 
     
     
         11 .- 15 . (canceled) 
     
     
         16 . The test kit of  claim 1  wherein at least 70% of the plurality of distinct food preparations, when adjusted for a single gender, has 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. 
     
     
         17 .- 19 . (canceled) 
     
     
         20 . The test kit of  claim 1  wherein the plurality of distinct food preparations is crude aqueous extracts. 
     
     
         21 . (canceled) 
     
     
         22 . The test kit of  claim 1  wherein the plurality of distinct food preparations is processed aqueous extracts. 
     
     
         23 . (canceled) 
     
     
         24 . The test kit of  claim 1  wherein the solid carrier is a well of a multiwall plate, a bead, an electrical sensor, a chemical sensor, a microchip or an adsorptive film. 
     
     
         25 . (canceled) 
     
     
         26 . 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.   
     
     
         27 . The method of  claim 26  wherein the bodily fluid of the patient is whole blood, plasma, serum, saliva, or a fecal suspension. 
     
     
         28 . The method of  claim 26  wherein the step of contacting a food preparation is performed with a plurality of distinct food preparations. 
     
     
         29 . (canceled) 
     
     
         30 . The method of  claim 28  wherein the plurality of distinct food preparations is prepared from food items of Table 1 or selected from a group consisting of cocoa, tea, oat, cabbage, cow milk, onion, honey, rye, corn, yeast, wheat, soybean, egg, tuna, lemon, pineapple, cucumber, orange, halibut, walnut, grapefruit, cane sugar, chicken, blueberry, and shrimp, and optionally from a group consisting of crab, barley, strawberry, pork, rice, beef, cashew, codfish, potato, white Sesame, broccoli, almond, turkey, scallop, and salmon. 
     
     
         31 .- 33 . (canceled) 
     
     
         34 . The method of  claim 28  wherein the plurality of distinct food preparations has an average discriminatory p-value of ≤0.05 as determined by raw p-value or an average discriminatory p-value of ≤0.08 as determined by FDR multiplicity adjusted p-value. 
     
     
         35 .- 41 . (canceled) 
     
     
         42 . The method of  claim 26  wherein the step of measuring IgG bound to the at least one component of the food preparation is performed via an immunoassay test. 
     
     
         43 . (canceled) 
     
     
         44 . The method of  claim 26  wherein the gender-stratified reference value for the food preparation is an at least a 90 th  percentile value. 
     
     
         45 . (canceled) 
     
     
         46 . 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.   
     
     
         47 . (canceled) 
     
     
         48 . The method of  claim 46  wherein the plurality of distinct food preparations includes at least two food preparations prepared from food items of Table 1 or selected from a group consisting of cocoa, tea, oat, cabbage, cow milk, onion, honey, rye, corn, yeast, wheat, soybean, egg, tuna, lemon, pineapple, cucumber, orange, halibut, walnut, grapefruit, cane sugar, chicken, blueberry, and shrimp, and optionally from a group consisting of crab, barley, strawberry, pork, rice, beef, cashew, codfish, potato, white Sesame, broccoli, almond, turkey, scallop, and salmon. 
     
     
         49 .- 53 . (canceled) 
     
     
         54 . The method of  claim 46  wherein the plurality of distinct food preparations has 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. 
     
     
         55 .- 59 . (canceled) 
     
     
         60 . The method of  claim 46  wherein the bodily fluid of the patient is whole blood, plasma, serum, saliva, or a fecal suspension. 
     
     
         61 . (canceled) 
     
     
         62 . The method of  claim 46  wherein the predetermined percentile rank is an at least 90 th  percentile rank. 
     
     
         63 .- 98 . (canceled)