4012 – ANApro

Highlights

• Use of recombinant and highly purified nuclear and cytoplasmic antigens
• Semi-quantitative detection in human serum
• Use as an aid in the diagnosis of systemic autoimmune disorders
• Detection of both autoantibodies to dsDNA and extractable nuclear/cytoplasmic antigens in one test plate
• Use of recombinant and highly purified antigens for maximum specificity
• Manual test for professional in vitro diagnostic use
• CE marked

Intended Use

The ANApro is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the separate determination of IgG antibodies against nuclear and cytoplasmic antigens (dsDNA, RNP, Sm, SS-A, SS-B, Scl-70, CENP, Jo-1) in human serum. The assay allows detection of total autoantibodies and provides a complete profile of nuclear and cytoplasmic reactivity. ANApro is intended as an aid in the diagnosis of systemic autoimmune disorders in combination with other clinical findings and laboratory tests. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

The presence of autoantibodies against nuclear and cytoplasmic components is a hallmark of systemic autoimmune diseases such as systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA), and dermatomyositis. Clinicians routinely detect these antibodies in patient samples, and their presence plays a critical role in diagnosing, monitoring, and differentiating systemic autoimmune disorders.

ANApro enables the separate detection of autoantibodies to dsDNA and extractable nuclear and cytoplasmic protein antigens. By combining recombinant antigens with highly purified native antigens, the assay ensures high specificity and sensitivity. The test allows rapid, comprehensive assessment of the full autoantibody pattern on a single microtiter plate, supporting effective laboratory screening and aiding clinical decision-making.