# US 10,309,970 B2 · Compositions, devices, and methods of IBS sensitivity testing

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- Number: US 10,309,970 B2
- Document ID: US10309970B2
- Status: Granted
- Kind: B2
- Application number: 15/526,240
- Filed: 2015-11-13
- Published: 2017-11-09
- Granted: 2019-06-04
- Earliest claimed: 2014-11-14
- Assignees: Biomerica, Inc.
- Applicants: Biomerica, Inc.
- Inventors: Elisabeth Laderman; Zackary Irani-Cohen
- Web page: https://patentgrep.com/patent/US10309970B2

## CPC

- G01N 33/6845: {Methods of identifying protein-protein interactions in protein mixtures}
- G01N 33/543: with an insoluble carrier for immobilising immunochemicals
- G01N 2800/065: Bowel diseases, e.g. Crohn, ulcerative colitis, IBS
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## 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.

## Claims

### Claim 1

An irritable bowel syndrome (IBS) test kit panel consisting essentially of:
a plurality of distinct IBS trigger food preparations immobilized to an individually addressable solid carrier;
wherein the plurality of distinct IBS trigger food preparations each have an IBS raw p-value of ≤0.07 or an IBS false discovery rate (FDR) multiplicity adjusted p-value of ≤0.10; and
wherein the IBS test kit panel has at least ten distinct IBS trigger food preparations.

### Claim 2 (depends on 1)

The test kit panel of claim 1, wherein the plurality of distinct IBS trigger food preparations each have an IBS raw p-value of ≤0.05 or an IBS FDR multiplicity adjusted p-value of ≤0.08.

### Claim 3 (depends on 1)

The test kit panel of claim 1, wherein the FDR multiplicity adjusted p-value is adjusted for at least one of age or gender.

### Claim 4 (depends on 1)

The test kit panel of claim 1, wherein the plurality of distinct IBS trigger food preparations is crude aqueous extracts or processed aqueous extracts.

### Claim 5 (depends on 1)

The test kit panel of claim 1, wherein the solid carrier is selected from the group consisting of a microwell plate, a microfluidic device, a dipstick, a membrane-bound array, a bead, an adsorptive film and a sensor.