Assay for anti-INGAP antibodies
OwnerAaron Vinik, David Taylor-Fishwickinventors
Life of this patent
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Abstract
A solid phase assay is used for detecting antibodies to INGAP104-118 peptide, a 15-amino acid peptide that is the biologically active portion of islet neogenesis associated protein (INGAP). The isotype of the antibodies to INGAP104-118 peptide can be determined. A kit can also be used in the detection of anti-INGAP104-118 antibodies. Endogenous autoantibodies or antibody production during therapeutic treatment of a mammal with INGAP104-118 can be monitored.
Claims25
A method for detecting antibodies to INGAP104-118 peptide in a test sample and determining isotype of said antibodies, comprising:
- contacting a test sample from a human with INGAP104-118 peptide bound to a solid support, wherein the contacting is under conditions sufficient for binding an anti-INGAP104-118 antibody to the INGAP104-118 peptide;
- contacting the solid support with an isotype-specific antibody which specifically binds antibody molecules of one isotype of the human;
- and
- determining the isotype-specific antibody bound to the solid support, wherein detection antibody bound to the solid support indicates that the test sample contains antibodies to INGAP104-118 peptide and that the antibodies to INGAP104-118 peptide are of the one isotype;
- wherein the test sample is selected from the group consisting of blood, serum and plasma.
A kit for detecting an anti-INGAP104-118 antibody in a test sample of a mammal comprising:
- an INGAP104-118 peptide;
- and
- a detection antibody.
A method for detecting neutralizing antibodies in a patient undergoing treatment with an Islet Neogenesis Associated Protein, comprising:
- collecting a test sample from a patient being administered a therapeutic protein selected from the group comprising sequences 104-118 of SEQ ID NO 2, sequences 1-175 of SEQ ID No 2 or fragments thereof,
- contacting the test sample with peptide corresponding to the therapeutic protein bound to a solid support under conditions sufficient for binding an antibody to the therapeutics protein,
- contacting any test sample bound to the therapeutic protein on the solid support with a detection antibody which specifically binds to antibody molecules of all isotypes of the mammal;
- washing the solid substrate to remove any unbound detection antibody molecules, and
- determining the presence of detection antibody bound to the solid support, wherein the presence of any detection antibody bound to the solid support indicates that the test sample contains neutralizing antibodies to the therapeutic protein.
The method of claim 25 wherein the detectable label is selected from the group consisting of fluorescent molecules, chemiluminescent molecules, radioactive molecules, and dye molecules.
Dependencies are inferred from the claim text.