Methods to predict risk for celiac disease by detecting anti-flagellin antibody levels
AssigneeNestec S.A.
InventorDerren M. Barken
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Abstract
The present invention provides methods, assays, and kits for predicting or stratifying the risk of celiac disease (CD) based upon HLA-DQ genotype and/or anti-flagellin antibody levels. Such risk prediction or stratification can provide benefits to family members of CD patients, to a subset of patients who are being evaluated clinically for CD, and to researchers, who can utilize this strategy to establish inclusion criteria for participation in research studies investigating potential preventive interventions.
Claims24
A method for aiding in the prediction of whether an individual having a relative with celiac disease (CD) is at risk of developing CD, the method comprising:
- (a) contacting a sample from the individual with a CBir1 flagellin antigen under conditions suitable to form a complex of the CBir1 flagellin antigen and an anti-CBir1 flagellin antibody, wherein the CBir1 flagellin antigen comprises the amino terminal conserved region (amino acid residues 1-147) of the sequence set forth in SEQ ID NO:1;
- (b) contacting the complex with a labeled antibody to form a labeled complex;
- (c) detecting the level of the labeled complex with a detection device, thereby determining a level of anti-CBir1 flagellin antibodies in the sample;
- and
- (d) associating an elevated level of anti-CBir1 flagellin antibodies in the sample relative to a control with a high risk of developing CD,
- thereby aiding in the prediction of whether an individual having a relative with CD is at risk of developing CD.
A method for aiding in the prediction of whether an individual positive for anti-endomysial antibodies (EMA) is at risk of developing celiac disease (CD), the method comprising:
- (a) contacting a sample from the individual with a CBir1 flagellin antigen under conditions suitable to form a complex of the CBir1 flagellin antigen and an anti-CBir1 flagellin antibody, wherein the CBir1 flagellin antigen comprises the amino terminal conserved region (amino acid residues 1-147) of the sequence set forth in SEQ ID NO:1;
- (b) contacting the complex with a labeled antibody to form a labeled complex;
- (c) detecting the level of the labeled complex with a detection device, thereby determining a level of anti-CBir1 flagellin antibodies in the sample;
- and
- (d) associating an elevated level of anti-CBir1 flagellin antibodies in the sample relative to a control with a high risk of developing CD,
- thereby aiding in the prediction of whether an individual positive for anti-EMA is at risk of developing CD.
Dependencies are inferred from the claim text.