Method for identifying autoimmune disease, method for detecting anti-Reg protein autoantibody and diagnostics for autoimmune disease
View Patent ↗A method for judging an autoimmune disease by detecting the existence of an anti-Reg protein autoantibody in a specimen; and a method for judging insulin-dependent or non-insulin-dependent diabetes mellitus. A method for detecting an anti-Reg protein autoantibody by bringing into a specimen into contact with an antigen component and detecting the formation of an immune complex. A reagent for diagnosing autoimmune disease which contain an antigen component capable of binding specifically to the anti-Reg protein autoantibody; and a reagent for diagnosing insulin-dependent or non-insulin-dependent diabetes mellitus.
1. A method for identifying a human autoimmune disease in a human patient suspected of having autoimmune disease, which comprises:
providing a specimen from the patient;
detecting a human anti-Reg protein autoantibody in the specimen; and
identifying a human autoimmune disease in the patient by comparing a level of the human anti-Reg protein autoantibody in the specimen to an average level of human anti-Reg protein autoantibody in a healthy population which does not have a human autoimmune disease.
2. The method of claim 1 , wherein the level of the human anti-Reg protein autoantibody in the specimen is indicative of autoimmune disease in the patient when the level in the sample is at least about 3 standard deviation units above the average level in the healthy population.
3. A method for identifying diabetes mellitus in a human patient suspected of having diabetes mellitus, which comprises:
providing a specimen from the patient;
detecting a human anti-Reg protein autoantibody in the specimen; and
identifying diabetes mellitus in the patient by comparing a level of the human anti-Reg protein autoantibody in the specimen to an average level of human anti-Reg protein autoantibody in a healthy population which does not have diabetes mellitus.
4. The method of claim 3 , wherein the level of the human anti-Reg protein autoantibody in the specimen is indicative of diabetes mellitus in the patient when the level in the sample is at least about 3 standard deviation units above the average level in the healthy population.
5. The method for identifying diabetes mellitus according to claim 3 , wherein the diabetes mellitus to be identified is insulin-dependent diabetes mellitus or non-insulin dependent diabetes mellitus.
6. A method for detecting a human anti-Reg protein autoantibody which comprises:
providing a specimen;
bringing the specimen into contact with a human Reg protein capable of binding specifically to the human anti-Reg protein autoantibody in the specimen; and
detecting an immune complex resulting from a reaction of the human anti-Reg protein autoantibody in the specimen with the human Reg protein capable of binding specifically to the human anti-Reg protein autoantibody in the specimen.
7. The method for detecting a human anti-Reg protein autoantibody according to claim 6 , wherein the human Reg protein is an artificially synthesized Reg protein.
8. A reagent comprising latex particles, wherein a human Reg protein capable of binding specifically to a human anti-Reg protein autoantibody is directly immobilized to the latex particle.
9. The reagent according to claim 8 , wherein the human Reg protein is an artificially synthesized Reg protein.
10. A reagent which comprises a human Reg protein capable of binding specifically to a human anti-Reg protein autoantibody and a labeled second antibody which reacts with the human anti-Reg protein autoantibody.
11. The reagent according to claim 10 , wherein the human Reg protein is an artificially synthesized Reg protein.