5032 – ANAscreen quant

Highlights

• Detection of IgG antibodies against nuclear and cytoplasmic antigens (ANA)
• Supports diagnosis of systemic autoimmune diseases (SLE, Sjögren’s syndrome, PSS, MCTD, RA, dermatomyositis)
• ELISA-based immunoassay using HeLa nuclei, native and recombinant antigens
• Sensitive and specific antibody detection
• Semi-automated or manual handling in professional laboratories
• Ready-to-use reagents (except wash buffer)
• Short incubation times, room temperature processing
• Quantitative or qualitative determination of antibody levels
• Validated for routine diagnostic use
• CE marked

Intended Use

The ANAscreen quant is a quantitative enzyme-linked immunosorbent assay (ELISA) for the determination of IgG antibodies against nuclear and cytoplasmic antigens in human serum. The ANAscreen quant is intended as an aid in the diagnosis of systemic autoimmune disorders in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Autoimmune Diseases: Overview and Types

Autoimmune diseases arise when the immune system produces antibodies and autoreactive T cells that attack the body’s own structures, causing local or systemic inflammation. Any organ or tissue can be affected. Researchers have identified hundreds of autoimmune diseases, generally classified into organ-specific, systemic (non-organ-specific), or mixed forms. Organ-specific diseases primarily affect a single organ, while systemic diseases, such as collagenosis or other systemic inflammatory rheumatic diseases, often involve antibodies against nuclear or cytoplasmic antigens present in nearly all cells.

Prevalence, Diagnosis, and Laboratory Testing

Autoimmune diseases affect about 5 to 10% of the population, with women more commonly affected than men. Common examples include psoriasis, rheumatoid arthritis (RA), type 1 diabetes, multiple sclerosis, Crohn’s disease, and autoimmune thyroid diseases such as Hashimoto’s thyroiditis and Graves’ disease. Diagnosis relies on clinical symptoms and laboratory tests. Detection of antibodies against nuclear or cytoplasmic antigens (ANA) confirms systemic autoimmune diseases such as systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed collagenosis (MCTD), RA, or dermatomyositis. ELISA using HeLa cell nuclei, native, and recombinant antigens provides sensitive and reliable IgG antibody detection to support accurate diagnosis.