US2016305954A1PendingUtilityA1

Diagnostic testing for immunologic food sensitivity

Assignee: FINE KENNETH DAVINPriority: Apr 17, 2015Filed: Apr 14, 2016Published: Oct 20, 2016
Est. expiryApr 17, 2035(~8.7 yrs left)· nominal 20-yr term from priority
G01N 2800/06B01L 3/5023G01N 2021/752G01N 2800/24G01N 33/6893G01N 33/6854B01L 2300/0825A61B 10/0038G01N 2021/757G01N 2021/7759G01N 21/78B01L 2300/0636G01N 21/75
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Claims

Abstract

In various implementations, a noninvasive, food sensitivity test may be utilized to identify one or more food sensitivities. A fecal sample may be obtained. The food sensitivity test may be performed on the obtained fecal sample. One or more food sensitivities may be identified based on the food sensitivity test.

Claims

exact text as granted — not AI-modified
1 . A diagnostic test kit to identify food sensitivity in humans, wherein the kit comprises:
 a diagnostic test to identify the presence of a first set of food sensitivities in a human, wherein the diagnostic test comprises:
 a substrate; and 
 a test region, wherein the test region comprises one or more antibody binding agents coupled to the substrate, wherein at least one of the antibody binding agents is adapted to couple to one or more first antibodies associated with one or more food sensitivities in the first set of food sensitivities when one or more of the first antibodies is present in a fecal sample obtained from the human; 
 wherein the diagnostic test is configured to contact the fecal sample of the human to allow identification of the presence of the first set of food sensitivities; and wherein one or more of the first antibodies, if present in the fecal sample, is transferred to the test region of the diagnostic test by the contact. 
   
     
     
         2 . The kit of  claim 1  wherein the diagnostic test comprises a stick test, and wherein the stick test comprises:
 a first end, wherein the first end comprises a handle to allow a user to hold the stick test without contacting the fecal sample; and 
 a second opposing end, wherein the second opposing end contacts the fecal test to allow transfer of one or more of the first antibodies, if present in the fecal sample, to the test region of the diagnostic test. 
 
     
     
         3 . The kit of  claim 1  wherein the diagnostic test further comprises an absorbent region adapted to transfer a testing portion of a fecal sample from the fecal sample to the test region of the diagnostic test, wherein the absorbent region contacts the fecal sample and absorbs fluid from the fecal sample to transfer to the test region, and wherein the fluid from the fecal sample comprises at least a portion of the antibodies present in the fecal sample. 
     
     
         4 . The kit of  claim 1  wherein the diagnostic test further comprises one or more flags adapted to indicate coupling of one or more first antibodies in a fecal sample with one or more of the antibody binding agents of the diagnostic test, and wherein one or more of the flags provides a visual indication that at least one of the first set of food sensitivities is present in the human associated with the fecal sample. 
     
     
         5 . The kit of  claim 1  wherein the diagnostic test is adapted to allow fluid from the fecal sample to flow between two or more regions of the diagnostic test. 
     
     
         6 . The kit of  claim 1  wherein at least one of the antibody binding agents comprises an IgA conjugate associated with an IgA antibody associated with one or more food sensitivities in the set of food sensitivities, wherein the IgA conjugate binds to the IgA antibody when the IgA antibody is proximate the IgA conjugate. 
     
     
         7 . The kit of  claim 1  wherein the testing region comprises one or more flags coupled to one or more of the antibody binding agents such that each flag is altered when an antibody from a fecal sample couples with an antibody binding agent, and wherein altering one or more of the flags produces a visually identifiable change. 
     
     
         8 . The kit of  claim 1  wherein the testing region comprises a plurality of different antibody binding agents associated with a plurality of different food sensitivities. 
     
     
         9 . The kit of  claim 1  wherein the diagnostic test is integrated with a specimen container, wherein the specimen container is adapted to allow a testing portion of the fecal sample to be disposed in the specimen container to allow identification of the first set of food sensitivities, and wherein the diagnostic test is positioned in the specimen container to allow contact with the testing portion of the fecal sample. 
     
     
         10 . A diagnostic test kit to identify food sensitivity in humans, wherein the kit comprises:
 a fecal sample collection tool; and   one or more diagnostic tests to identify the presence of a first set of food sensitivities in a human, wherein each of the diagnostic tests are integrated with the fecal sample collection tool, and wherein each of the diagnostic tests comprise:
 a substrate; and 
 a test region, wherein the test region comprises one or more antibody binding agents coupled to the substrate, and wherein at least one of the antibody binding agents is adapted to couple to one or more first antibodies associated with the first set of food sensitivities when one or more of the first antibodies is present in the fecal sample obtained from the human; 
   wherein the fecal sample collection tool is adapted to allow at least one of the diagnostic tests to contact the fecal sample to allow identification of the presence of the first set of food sensitivities; and wherein one or more of the first antibodies, if present in the fecal sample, is transferred to the test region of at least one of the diagnostic tests by the contact.   
     
     
         11 . The kit of  claim 10  wherein one or more of the diagnostic test is positioned in the fecal sample collection tool such that the diagnostic test contacts the fecal sample during collection of the fecal sample. 
     
     
         12 . The kit of  claim 10  wherein one or more of the diagnostic tests are positioned on the fecal sample collection tool such that a testing portion of the fecal sample is moved by a user to contact one or more of the diagnostic tests and allow identification of the first set of food sensitivities. 
     
     
         13 . The kit of  claim 10  wherein the fecal sample collection tool includes an opening to allow at least a portion of fluid from a fecal sample to drain from the fecal sample collection tool. 
     
     
         14 . The kit of  claim 10  wherein the fecal sample collection tool is adapted to allow at least one of a hydrating agent or a solution including flags to be applied to the fecal sample in the fecal sample collection tool. 
     
     
         15 . The kit of  claim 10  wherein at least one of the diagnostic tests comprises one or more flags adapted to indicate coupling of one or more first antibodies in the fecal sample with one or more of the antibody binding agents, and wherein one or more of the flags provides a visual indication that at least one of the first set of food sensitivities is present in the human associated with the fecal sample. 
     
     
         16 . The kit of  claim 10  wherein the fecal sample collection tool comprises a removable stop, and wherein the stop is adapted to close an opening in the fecal sample collection tool, and wherein when the stop is removed at least one of fluid and/or the fecal sample may be drained from the fecal sample collection tool via the opening. 
     
     
         17 . The kit of  claim 10  wherein the diagnostic test comprises a plurality of antibody binding agents associated with a set of foods. 
     
     
         18 . The kit of  claim 10  wherein at least one of the antibody binding agents comprises an IgA conjugate associated with an IgA antibody associated with one or more food sensitivities in the set of food sensitivities, wherein the IgA conjugate binds to the IgA antibody when the IgA antibody is proximate the IgA conjugate. 
     
     
         19 . The kit of  claim 10  wherein the testing region comprises one or more flags coupled to one or more of the antibody binding agents such that when an antibody couples with an antibody binding agent the flag is altered. 
     
     
         20 . The kit of  claim 10  wherein each of the diagnostic tests is adapted to provide a visually identifiable change to identify the presence of the first set of food sensitivities in the fecal sample.

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