Compositions, devices, and methods of eczema food sensitivity testing
AssigneeBiomerica, Inc.
InventorZackary Irani-Cohen
Life of this patent
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Abstract
Contemplated test panels, test kits, and methods using same for food sensitivity in subjects with eczema.
Claims126
A test panel for testing food sensitivity in a human subject diagnosed with or suspected of having eczema, comprising:
- one or more distinct food preparations, wherein each distinct food preparation is independently coupled to a spatially addressable solid carrier;
- wherein at least 70% of the one or more distinct food preparations have a raw p-value of ≤0.07 or a false discovery rate (FDR) multiplicity adjusted p-value of ≤0.10.
A test panel for testing food sensitivity in a human subject diagnosed with or suspected of having eczema, consisting essentially of:
- one or more distinct food preparations, wherein each distinct food preparation is independently coupled to a spatially addressable solid carrier;
- wherein the one or more distinct food preparations have a raw p-value of ≤0.07 or a false discovery rate (FDR) multiplicity adjusted p-value of ≤0.10.
An eczema test panel for the simultaneous detection of one or more eczema trigger foods, comprising:
- a plurality of distinct eczema trigger food preparations, wherein each distinct eczema trigger food preparation is independently immobilized to a spatially addressable solid carrier;
- wherein at least 70% of the plurality of distinct eczema trigger food preparations each have a raw p-value of ≤0.07 or a FDR multiplicity adjusted p-value of ≤0.10.
An eczema test panel for the simultaneous detection of one or more eczema trigger foods, consisting essentially of:
- a plurality of distinct eczema trigger food preparations, wherein each distinct eczema trigger food preparation is independently immobilized to a spatially addressable solid carrier;
- wherein the plurality of distinct eczema trigger food preparations each have a raw p-value of ≤0.07 or a FDR multiplicity adjusted p-value of ≤0.10.
A method of identifying one or more distinct food preparations for a subject known to have or is suspected of having eczema, the method comprising:
- contacting a bodily fluid of a subject that is known to have or is suspected of having eczema with a plurality of distinct food preparations coupled to a solid carrier, wherein the contacting is performed under conditions that allow antibodies from the bodily fluid to bind to a first distinct food preparation,
- detecting the antibodies bound to the first distinct food preparation to obtain a first immunoassay signal;
- comparing the first immunoassay signal to a first control signal, and
- identifying one or more distinct food preparations positive for the subject known to have or is suspected of having eczema.
A method of identifying a human subject in need of medical treatment for eczema, the method comprising:
- obtaining a bodily fluid from the subject,
- contacting the bodily fluid of the subject with a plurality of distinct food preparations coupled to a solid carrier, wherein the contacting is performed under conditions that allow antibodies from the bodily fluid to bind to each distinct food preparation in the plurality,
- detecting the antibodies bound to the each distinct food preparation in the plurality to obtain an immunoassay signal for each distinct food preparation in the plurality;
- comparing the immunoassay signal for each distinct food preparation in the plurality to a control signal for each distinct food preparation in the plurality, and
- identifying the distinct food preparations positive for the subject, thereby determining the need for medical treatment for the subject.
A method for monitoring the progression of eczema in a human subject, the method comprising
- contacting a bodily fluid obtained from the subject at a first time point with a plurality of distinct food preparations coupled to a solid carrier, wherein the contacting is performed under conditions that allow antibodies from the bodily fluid to bind to each distinct food preparation in the plurality,
- detecting the antibodies bound to the each distinct food preparation in the plurality at the first time point to obtain an immunoassay signal for each distinct food preparation in the plurality;
- contacting a bodily fluid obtained from the subject at a second time point with a plurality of distinct food preparations coupled to a solid carrier, wherein the contacting is performed under conditions that allow antibodies from the bodily fluid to bind to each distinct food preparation in the plurality,
- detecting the antibodies bound to the each distinct food preparation in the plurality at the second time point to obtain an immunoassay signal for each distinct food preparation in the plurality;
- comparing the immunoassay signal for each distinct food preparation in the plurality at the first time point and the second time point, wherein an increased amount of at least one immunoassay signal present in the bodily fluid obtained at the second time point compared to the bodily fluid at the first time point is indicates progression of eczema.
A method for monitoring the efficacy of a treatment for eczema in a human subject, the method comprising
- contacting a bodily fluid obtained from the subject at a first time point with a plurality of distinct food preparations coupled to a solid carrier, wherein the contacting is performed under conditions that allow antibodies from the bodily fluid to bind to each distinct food preparation in the plurality,
- detecting the antibodies bound to the each distinct food preparation in the plurality at the first time point to obtain an immunoassay signal for each distinct food preparation in the plurality;
- administering a treatment regimen,
- contacting a bodily fluid obtained from the subject at a second time point with a plurality of distinct food preparations coupled to a solid carrier, wherein the contacting is performed under conditions that allow antibodies from the bodily fluid to bind to each distinct food preparation in the plurality,
- detecting the antibodies bound to the each distinct food preparation in the plurality at the second time point to obtain an immunoassay signal for each distinct food preparation in the plurality;
- comparing the immunoassay signal for each distinct food preparation in the plurality at the first time point and the second time point, wherein a decreased amount of at least immunoassay signal present in the bodily fluid obtained at the second time point compared to the bodily fluid at the first time point is indicative of an effective treatment for eczema.
A method of generating a test panel for food sensitivity in a human subject known to have or suspected of having eczema, the method comprising:
- obtaining immunoassay results for a plurality of distinct eczema trigger food preparations, wherein the immunoassay results are based on bodily fluids of subjects known to have or suspected of having eczema and bodily fluids of a control group not known to have or not suspected to have eczema;
- selecting a plurality of the distinct food preparations, wherein the distinct food preparations are food preparations having a raw p-value of ≤0.07 or a false discovery rate (FDR) multiplicity adjusted p-value of ≤0.10;
- and
- generating a test comprising of the selected distinct food preparations.
Dependencies are inferred from the claim text.