5016 – DotDiver ANA

Highlights

• Detection of IgG antibodies against multiple nuclear and cytoplasmic antigens (Sm, Sm/RNP, SS-A, SS-B, Jo-1, Scl-70, PM-Scl-100, CENP-A/B)
• Qualitative dot immunoassay for human serum samples
• Supports the diagnosis of systemic autoimmune diseases in combination with clinical and laboratory findings
• Ready-to-use reagents for consistent and reproducible results
• Colorimetric detection via alkaline phosphatase substrate (BCIP/NBT)
• Optimized for routine laboratory workflow with high specificity
• Automated
• CE marked

Intended Use

The DotDiver ANA is a qualitative dot immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (Sm, Sm/RNP, SS-A, SS-B, Jo-1, Scl-70, PM-Scl-100, CENP-A/B) in human serum. The DotDiver ANA is intended as an aid in the diagnosis of systemic autoimmune diseases in conjunction with other clinical and laboratory findings. The immunoassay is designed for semi-automated use with the DotDiver instrument. The immunoassay is designed for professional in vitro diagnostic use.

Diagnostic Relevance

Systemic autoimmune diseases are characterized by the production of autoantibodies directed against components of the cell nucleus or cytoplasm. These autoantibodies often appear early in disease progression, making their detection crucial for timely diagnosis and monitoring. Detection of anti-nuclear antibodies (ANA) plays a central role in diagnosing systemic lupus erythematosus (SLE), Sjögren’s syndrome, systemic sclerosis, dermatomyositis, mixed connective tissue disease, and rheumatoid arthritis.

The DotDiver ANA provides a sensitive and specific method for identifying multiple antibody specificities simultaneously. By coating individual dots on the test strip with highly purified antigens, the assay allows clinicians to observe precise antibody-antigen interactions. The colorimetric reaction, catalyzed by alkaline phosphatase, produces a visible, stable precipitate proportional to the antibody activity in the sample. This approach supports differential diagnosis, aids in monitoring disease activity, and complements other serological and clinical assessments, contributing to a comprehensive evaluation of systemic autoimmune conditions.