Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Patent
1998-01-28
1999-12-21
Saunders, David
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
435 794, 435975, 436506, 53038822, 5303891, G01N 33564
Patent
active
060047607
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
This invention relates to the diagnosis of autoimmune disease. More specifically, it relates to a method for immunological assay of an autoimmune disease related antigen in a human body fluid by use of antibodies to IgG Fc-binding protein, and concerns a diagnostic kit for autoimmune disease which is used in this method.
BACKGROUND ART
Autoimmune disease is caused by an immune response to the antigen of one's own tissue. Alternatively, it occurs when an exogenous organism inhabiting one's body, or a product of the organism, is recognized as an antigen, and an immune response is induced to it. A hidden antigen which normally does not appear in the circulating blood, but is separated from immunocompetent cells, such as cerebral tissue, lens, thyroglobulin or sperm, may be released into the bloodstream by some trigger. Although being one's own body constituent, such a hidden antigen induces an immune response, eventually causing a pathologic state. Autoantibodies can easily develop against many intracellular constituents, but antibodies do not pass through the cell membrane, and thus do no harm to the tissue. Generally, the body is immunologically tolerant to self constituents, and undergoes no autoimmunity. Upon breakdown of immunological tolerance, however, autoantibodies may develop or cellular immunity to self may occur, causing a disease state. Many diseases have now been found to be such autoimmune diseases.
To treat autoimmune disease, corticosteroids or immunosuppressants are effective. To enhance the therapeutic effect of these drugs, early diagnosis of the disease is crucial. With ulcerative colitis or Crohn's disease, endoscopic examination is required for final diagnosis, and a simpler and safer method of diagnosis is demanded. A method by which the pathophysiology or progression of the disease can be known easily over time, if any, would be highly useful.
In autoimmune disease, production of various autoantibodies is considered an important phenomenon characterizing the disease. The mechanism which recognizes various antigens making up self's constituents and produces antibodies corresponding to them has not been thoroughly clarified yet. However, there have been attempts to use this mechanism for the diagnosis of autoimmune disease and the elucidation of its pathophysiology or etiology. Up to now, a considerable number of autoantibodies have been pointed out as having relation to particular autoimmune diseases. For the diagnosis of a certain type of autoimmune disease, screening for the corresponding autoantibodies is an inevitable test. Examples in actual practice are diagnosis of collagen disease using antinuclear antibodies, diagnosis of systemic lupus erythematosus using anti-dsDNA antibodies, diagnosis of scleroderma using autoantibodies to topoisomerase I, and diagnosis of primary biliary cirrhosis using antibodies to mitochondria-derived constituents.
The presence of IgG Fc binding protein, a protein binding specifically to the Fc region of immunoglobulin G or IgG, (Fc.gamma.BP: May be described as Fc.gamma. Binding Protein or IgGFcBP) has been reported by Kobayashi, one the present inventors, and colleagues (Kobayashi, K. et al., J. Immunol., 143:2567-2574, 1989). Specific binding of this protein to the IgG Fc region has been confirmed using a horseradish peroxidase (HRP)-labeled material. That is, Fc.gamma.BP binds only to the Fc region of IgG, but does not bind to IgGFab, IgA or IgM. Nor does Fc.gamma.BP cross-react with anti-Fc.gamma. receptor :, II or III antibodies. Kobayashi et al. further partially purified Fc.gamma.BP from human large intestine epithelial cells, and prepared mouse monoclonal antibodies using it as an antigen. They confirmed these antibodies to bind to mouse IgG as well as to Fc.gamma.BP (Kobayashi, K. et al., J. Immunol., 143:2567-2574, 1989; Kobayashi, K. et al., J. Immunol., 146:68-74, 1991). Morikawa, one the inventors, and colleagues cloned cDNA for Fc.gamma.BP with the use of monoclonal antibodies to Fc.gamma.BP, and clarified the nucleot
REFERENCES:
Kobayashi et al., J. Immunology, vol. 143, No. 8, pp. 2567-2574 (Oct. 15, 1989).
Kobayashi et al., J. Immunology, vol. 146, No. 1, pp. 68-74 (Jan. 1, 1991).
Kobayashi et al., Digestive Diseases and Sciences, vol. 39, No. 3, pp. 526-533 (Mar. 1994).
Hamada et al., Inflammatory Bowel Diseases, vol. 2, pp. 97-104 (1996).
Hamada et al., Immunology, vol. 74, pp. 298-303 (1991).
WPAT and JAPIO Abstracts of JP 63235868.
WPAT abd JAPIO Abstracts of JP 07067689.
Kobayashi Kensuke
Morikawa Minoru
Chugai Seiyaku Kabushiki Kaisha
Saunders David
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