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 to aid in the detection of Crohn's disease comprising:
(a) contacting a sample with an outer membrane protein antigen (OmpC antigen) or reactive fragment thereof, under conditions suitable to transform said OmpC antigen into a complex comprising OmpC antigen or reactive fragment thereof, and an IgA anti-OmpC antibody present in the sample;
(b) contacting said complex with an enzyme labeled indicator antibody to bind said complex with said enzyme labeled indicator antibody and thus transform said complex into a labeled complex;
(c) contacting said labeled complex with a substrate for said enzyme; and
(d) detecting the IgA anti-OmpC antibodies in said labeled complex, the presence of said IgA anti-OmpC antibodies providing an aid in the detection of Crohn's Disease.
2. The assay of claim 1 , wherein said sample is human serum.
3. The assay of claim 1 , wherein the assay is an enzyme-linked immunosorbent assay (ELISA) assay.
4. The assay of claim 1 , wherein detecting the presence of IgA anti-OmpC antibodies in said sample comprises the use of a detection device.
5. The assay of claim 4 , wherein said detection device comprises a spectrophotometer.
6. The assay of claim 1 , wherein said OmpC antigen comprises the amino acid sequence of SEQ ID NO: 1 or 90% identity thereof.
7. The assay of claim 1 , wherein said assay is performed on an assay system, said assay system comprising:
(a) a plate device comprising said 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) said indicator secondary antibody specific for an OmpC autoantibody; and
(c) instructions for detecting said OmpC autoantibody.
8. The assay system of claim 7 , wherein said plate device further comprises a control.
9. The assay system of claim 7 , wherein said indicator secondary antibody is an enzyme-labeled antibody.
10. The assay system of claim 9 , wherein said system further comprises a substrate for said enzyme-labeled antibody.
11. The assay system of claim 10 , wherein said substrate is transformed into a product and wherein said product is chromogenic.
12. The assay of claim 1 , wherein said assay is performed to facilitate earlier and appropriate treatment for Crohn's Disease patients.