Peptides, reagents and methods for detecting food allergy
Inventors
Getts, Robert C. • Kadushin, James • Sampson, Hugh A. • Bardina, Ludmilla • Grishina, Galina • GIMENEZ, Gustavo • Lin, Jing
Assignees
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Publication Number
US-12546775-B2
Publication Date
2026-02-10
Expiration Date
Abstract
Provided are peptide biomarkers for diagnosis of allergy, monitoring development of clinical tolerance in an allergic individual, and predicting whether an allergic subject is likely to develop clinical or natural tolerance over time. The invention also relates to diagnostic methods and diagnostic kits employing the peptide biomarkers.
Core Innovation
The invention provides methods using a plurality of milk peptides selected from SEQ ID NOs: 1-33, where each peptide is conjugated to a separately identifiable solid support. A subject serum is contacted with each solid support under conditions sufficient to permit binding of allergy associated immunoglobulin (AAI) in the serum to the peptide on each solid support to form a peptide-AAI complex. An AAI-specific labeling reagent is then bound to the peptide-AAI complex, and binding of the labeling reagent is analyzed to identify peptides recognized by the AAI in the serum of the subject.
For diagnosis, recognition of at least one peptide by AAI in the serum indicates that the subject is allergic to milk. For longitudinal use, the invention provides an initial profile of AAI reactivity of the subject’s serum to the peptide panel and a subsequent profile at a later time-point, using the same solid support-conjugated peptides and AAI-specific labeling reagent readout. The number of peptides recognized by AAI and/or the concentration of AAI recognizing each peptide are used to define initial and subsequent reactivity profiles.
The invention additionally detects clinical tolerance development and detects changes in allergy intensity over time by comparing initial and subsequent AAI reactivity profiles across the peptide panel. Development of clinical tolerance is indicated when the subsequent number of peptides recognized by AAI is less than the initial number and/or when the subsequent concentration of AAI recognizing at least one peptide is less than the initial concentration. An increase in intensity of allergy over time is indicated when the subsequent number of peptides recognized and/or the subsequent concentration recognizing at least one peptide is increased compared to the initial profile.
Claims Coverage
The document contains three independent claims directed to diagnosing milk allergy, detecting development of clinical tolerance, and detecting an increase in allergy intensity over time. Each independent claim uses a multiplex set of SEQ ID NOs: 1-33 peptides on separately identifiable solid supports, followed by AAI-specific labeling reagent binding and analysis of peptide recognition via AAI in serum. Across the independent claims, the number of peptides recognized and/or concentration of AAI recognizing each peptide define the comparative outcomes.
Multiplex peptide solid supports for milk allergy diagnosis by AAI recognition
A method for diagnosing a milk allergy in a subject by providing a plurality of milk peptides selected from SEQ ID NOs: 1-33, each peptide conjugated to a separately identifiable solid support; contacting each solid support with serum to form peptide-AAI complexes; binding an AAI-specific labeling reagent to the peptide-AAI complex; and analyzing binding to identify peptides recognized by AAI, wherein recognition of at least one peptide indicates that the subject is allergic to milk.
Comparative AAI reactivity profiles to detect development of clinical tolerance
A method for detecting development of clinical tolerance to milk in a subject allergic to milk comprising providing an initial profile of AAI reactivity to a plurality of milk peptides selected from SEQ ID NOs: 1-33; contacting solid-support conjugated peptides with serum at a subsequent time-point to form peptide-AAI complexes; binding an AAI-specific labeling reagent; and analyzing binding to identify a subsequent number of peptides recognized by AAI or a subsequent concentration of AAI that recognizes each peptide, wherein development of clinical tolerance is indicated when the subsequent number is less than the initial number and/or the subsequent concentration is less than the initial concentration for at least one peptide.
Longitudinal AAI reactivity increases to detect increased allergy intensity over time
A method for detecting an increase in intensity of allergy to milk over time in a subject allergic to milk comprising providing an initial profile of AAI reactivity to SEQ ID NOs: 1-33; contacting solid-support conjugated peptides with serum at a subsequent time-point; binding an AAI-specific labeling reagent; and analyzing binding to identify a subsequent number of peptides recognized by AAI or a subsequent concentration of AAI that recognizes each peptide, wherein an increase in the subsequent number and/or concentration compared to the initial profile indicates increased intensity of the allergic response to milk.
The independent claims cover diagnosis of milk allergy by identifying AAI-recognized peptides on individually solid-supported peptide panel members, detection of clinical tolerance by comparing initial and subsequent AAI reactivity profiles where tolerance corresponds to a decrease in number of recognized peptides and/or AAI concentration, and detection of worsening allergy intensity by comparing initial and subsequent AAI reactivity where increased number of recognized peptides and/or AAI concentration indicates increased intensity.
Stated Advantages
Enables diagnosing milk allergy based on recognition of at least one peptide by AAI in serum.
Detects development of clinical tolerance to milk by identifying decreases in the number of AAI-recognized peptides and/or the AAI concentration recognizing at least one peptide.
Detects an increase in intensity of milk allergy over time by identifying increases in the number of AAI-recognized peptides and/or the AAI concentration recognizing at least one peptide.
Documented Applications
Diagnosing a milk allergy in a subject by analyzing AAI recognition of SEQ ID NOs: 1-33 milk peptides presented on separately identifiable solid supports.
Detecting development of clinical tolerance to milk in a subject allergic to milk by comparing initial and subsequent AAI reactivity profiles across SEQ ID NOs: 1-33 peptides.
Detecting an increase in intensity of allergy to milk over time in a subject allergic to milk by comparing initial and subsequent AAI reactivity profiles across SEQ ID NOs: 1-33 peptides.
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