Assay methods and kits for diagnosing autoimmune disease

Details Assay methods and kits for diagnosing autoimmune disease Assay methods and kits for diagnosing autoimmune disease

1998-01-21

2000-10-10

Patterson, Jr., Charles L.

Chemistry: molecular biology and microbiology

Measuring or testing process involving enzymes or...

Involving antigen-antibody binding, specific binding protein...

435 76, 435975, 4351885, C12Q 100

Patent

active

061300497

DESCRIPTION:

BRIEF SUMMARY
FIELD OF THE INVENTION

This invention provides assay methods and kits for detecting the existence of or propensity toward developing autoimmune disease. Specifically, methodology is provided for performing a simple test on a biological fluid that will facilitate the identification of patients afflicted with or at risk for developing autoimmune disorders such as rheumatoid arthritis, systemic lupus erythematosus, autoimmune thyroiditis, Birdshot retinopathy and anti-coagulant deficiency due to autoantibodies.


BACKGROUND OF THE INVENTION

A key attribute of the immune system is the discrimination between self and non-self antigens. Surface recognition molecules on lymphocytes are sufficiently diverse for any antigen to find some lymphoid cells with surface antibody or T-cell receptor whose binding constant for antigen is high enough to lead to activation, thereby inducing the clonal expansion of cells recognizing that antigen. When these activated cell types (B and T cells) synthesize molecules (antibodies, T cell receptors) that react with self antigens, they are eliminated from the body. Immunologists refer to the inability to produce substances that react with self antigens as tolerance. The mechanisms that give rise to tolerance are poorly understood but involve rendering unreactive the clones of both B and T cells that would otherwise carry out anti-self reactions.
The immune system in mice becomes responsive to foreign antigens in the days just after birth. All antigens present in the body at the time the system matures are considered by the immune system to be self. Thus if foreign antigens are incorporated into a newborn mouse, subsequent challenge with the same antigen will not induce an immune response. Because new clones of lymphocytes appear in an animal throughout its life, the tolerance to self must be an active, ongoing process. Suppressor T lymphocytes are thought to play an important role in maintaining tolerance by specifically suppressing lymphocyte clones that react against self-antigens.
The consequences of the failure of tolerance can be severe. It is well known that certain autoimmune diseases are associated with autoantibodies directed against hormones and cell surface antigens. Examples of these diseases and associated antigens include the following:


______________________________________ AUTOINMUNE DISEASE ASSOCIATED ANTIGEN ______________________________________ Diabetes insulin, insulin receptor, glutamate decarboxylase Myasthenia gravis acetylcholine receptor Autoimmune thyroiditis thyroglobulin, thyroid peroxidase Systemic lupus erythmatosus small nuclear RNA, DNA and (SLE) histones, phospholipids Pernicious anemia gastric parietal cell associated antigens Rheumatoid arthritis collagen, IgG Wegener's Granuloma proteinase 3 Biliary cirrhosis pyruvate dehydrogenase ______________________________________
Related diseases, in the sense of having autoimmune disease-like components or mechanisms, include asthma and acquired immunodeficiency syndrome. Relevant antigens recognized by antibodies in these disorders are VIP (asthma), and neurolikin, VIP, HLA antigens and DNA (HIV).
Tissue injury in autoimmune disease occurs by several humoral and cell-mediated mechanisms. Autoantibodies alone can cause certain diseases, e.g., myasthenia gravis and Graves disease, as demonstrated by adoptive transfer via administration of antibodies in animal models. Rose, N. R. and I. R. Mackay, Editors. The Autoimmune Diseases.Orlando: Academic Press, Inc., 1985. In other diseases, tissue damage is believed to occur by a combination of autoantibodies, lymphocyte and macrophage infiltration, and the release of inflammatory mediators, including proteases.
Antibodies can recognize small arrays of atoms as well as large epitopes composed of as many as 25 amino acid residues. The target molecule for an antibody could be a small hapten or a macromolecule like a protein or nucleic acid.
Antigen recognition by antibodies occurs at complementarity de

REFERENCES:
Paul, S., et al. (1997) J. Immunol. 159(3), 1530-1536.
Kalaga, R, et al. (1995) J. Immunol. 155(5), 2695-2702.
Li, L, et al. (1995) J. Immunol. 154(7), 3328-3332.

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