5032 – ANAscreen quant

Highlights

• Use of a mixture of HeLa nuclei and recombinant as well as native antigens
• Ready-to-use (exception: wash buffer) and barcoded reagents
• Quality assured handling in routine laboratories
• Short incubation times (60 min / 30 min / 15 min) at room temperature
• Quantitative determination of IgG antibodies
• Results expressed in U/mL
• Excellent diagnostic sensitivity and specificity
• High precision within the measurement range
• CE marked
• Automatable

Intended Purpose

The ANAscreen quant is a quantitative immunoassay 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 are based on disorders of the immune system. Synthesized antibodies and autoreactive T cells are directed against endogenous structures and lead to local or systemic inflammatory reactions. In principle, any organ or tissue can be affected by an autoimmune disease. Accordingly, hundreds of autoimmune diseases have been described so far, which can be roughly divided into three groups: In organ-specific autoimmune diseases, individual organs are affected. Systemic, non-organ-specific autoimmune diseases include, for example, collagenosis or other systemic, inflammatory rheumatic diseases. In these cases, antibodies against nuclear or cytoplasmic antigens, which are found in almost all cells in the body, are often detected. In addition, different mixed forms of organ-specific and systemic autoimmune diseases are described.

About 5 to 10 % of the population are affected by an autoimmune disease. The most common are psoriasis, rheumatoid arthritis (RA), diabetes mellitus type 1, multiple sclerosis, Crohn‘s disease and autoimmune thyroid diseases such as Hashimoto‘s thyroiditis and Graves‘ disease. In general, autoimmune diseases are more common in women than in men.

The diagnosis of autoimmune diseases is made on the basis of the clinical symptoms and laboratory medical examinations. The clinical suspicion is confirmed in particular by the detection of antibodies against nuclear or cytoplasmic antigens (ANA) as a characteristic feature in systemic autoimmune diseases such as systemic lupus erythematosus (SLE), Sjögren‘s syndrome, progressive systemic sclerosis (PSS), mixed collagenosis (MCTD), rheumatoid arthritis (RA) or dermatomyositis. The ELISA (Enzyme Linked Immunosorbent Assay) based on a mixture of HeLa cell nuclei, native and recombinant antigens has proven particularly effective for the determination of IgG antibodies. The immunoassay offers the possibility of a sensitive antibody detection.