Diagnosis, prevention and treatment of Crohn's disease using the OmpC antigen
View Patent ↗The present invention provides a method of diagnosing Crohn's disease in a subject by determining the presence or absence or IgA anti-OmpC antibodies in the subject, where the presence of the IgA anti-OmpC antibodies indicates that the subject has Crohn's disease.
1. An assay system to aid in the detection of Crohn's disease, said assay system comprising:
(a) a plate comprising an OmpC antigen, or reactive fragment thereof, wherein said OmpC antigen comprises the amino acid sequence of SEQ ID NO:1 or 90% identity thereof;
(b) an indicator secondary antibody specific for an OmpC autoantibody; and
(c) instructions that specifically detect for Crohn's Disease by detecting for the presence of a complex of said OmpC antigen in (a), said OmpC autoantibody, and said indicator secondary antibody that specifically binds said OmpC autoantibody in (b), the presence of the formed complex having the OmpC autoantibody being indicative of Crohn's Disease.
2. The assay system of claim 1 , wherein said plate further comprises a control.
3. The assay system of claim 1 , wherein said indicator secondary antibody is an enzyme-labeled antibody.
4. The assay system of claim 3 , wherein said system further comprises a substrate for said enzyme-labeled antibody.
5. The assay system of claim 3 , wherein a product of said substrate is chromogenic.
6. The assay system of claim 1 , wherein said assay is performed to facilitate earlier and appropriate treatment for Crohn's Disease patients.
7. An assay kit for improving the diagnosis of Crohn's disease comprising:
(a) a plate well containing an OmpC antigen, or reactive fragment thereof;
(b) an enzyme-labeled anti IgA antibody; and
(c) instructions that specifically detect for Crohn's Disease by detecting for the presence of a complex of said OmpC antigen in (a), said OmpC autoantibody, and said indicator secondary antibody that specifically binds said OmpC autoantibody in (b), the presence of the formed complex having the OmpC autoantibody being indicative of Crohn's Disease.
8. The assay kit of claim 7 , wherein said kit comprises a control.
9. The assay kit of claim 7 , wherein said enzyme-labeled anti-IgA antibody is an indicator secondary antibody.
10. The assay kit of claim 9 , wherein said kit further comprises a substrate for said enzyme-labeled antibody.
11. The assay kit of claim 9 , wherein a product of said substrate is chromogenic.