Method for Identification of Atypical p-ANCA

Simple SummaryContent extracted from patent full text and abstract with AI.

This invention describes a method and related kits for the specific identification and quantification of 'atypical p-ANCA', a type of autoantibody. By discovering that these antibodies mainly bind to a protein called Tubulin-beta isotype 5 (TBB-5) from myeloid cells, and to the bacterial FtsZ protein or their variants, the invention enables the development of precise and reproducible diagnostic tests—especially solid-phase immunoassays like ELISA—for chronic inflammatory bowel diseases (such as ulcerative colitis and Crohn’s disease) and autoimmune liver diseases (notably autoimmune hepatitis and primary sclerosing cholangitis). The patent also covers recombinant production of the antigens and their optimized use in assay kits.

Use CasesContent extracted from patent full text and abstract with AI.

• Accurate diagnosis of chronic inflammatory bowel diseases (ulcerative colitis, Crohn’s disease) via detection of atypical p-ANCA antibodies in patient sera.
• Diagnosis and screening of autoimmune liver diseases such as autoimmune hepatitis (AIH) and primary sclerosing cholangitis (PSC).
• Production of highly specific and sensitive ELISA kits or other solid-phase immunoassays for clinical laboratories to detect atypical p-ANCA.
• Use in research settings for studying autoimmune responses in inflammatory and hepatic diseases.
• Development of standardized assay components (antigens, tagged proteins, kits) for global diagnostic use.

BenefitsContent extracted from patent full text and abstract with AI.

• Allows for highly specific and sensitive detection of atypical p-ANCA, significantly improving diagnostic accuracy for autoimmune liver and chronic intestinal diseases.
• Reduces reliance on subjective, labor-intensive immunofluorescence microscopy by enabling robust, easy-to-interpret ELISA or similar immunoassays.
• Kits can be standardized and mass-produced using recombinant antigens, ensuring consistency, scalability, and quality-control internationally.
• Detection of atypical p-ANCA serves as the most reliable serological marker for certain diseases (e.g., PSC), where other markers are lacking or insufficient.
• Kits and methods minimize cross-reactivity, improving result reliability and reducing false positives or negatives.
• Assay can be performed in standard clinical laboratories without specialized training or equipment, expanding accessibility to advanced diagnostics.

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Patent Abstract

The invention relates to a method for the identification of atypical p-ANCA, kits suitable for the same and application of said method to the diagnosis of chronic inflammatory intestinal diseases and autoimmune liver diseases.