5291 – DotDiver ANA 18

Highlights

• Use of highly purified and recombinant nuclear and cytoplasmic antigens (dsDNA, nucleosomes, Sm, Sm/RNP, ribosomal P0, histones, U1 snRNP, SS-A/Ro60, SS-A/Ro52, SS-B, Scl-70, PM/Scl-100, CENP-A/B, PCNA, Jo-1, M2, DFS-70, and F-actin)
• Qualitative line immunoassay for simultaneous multi-antigen detection
• Supports diagnosis of systemic autoimmune and inflammatory rheumatic diseases
• Ready-to-use breakable test strips with integrated reaction and cut-off controls
• Semi-automated processing with the DotDiver instrument
• High specificity for reliable autoantibody detection
• Allows differentiation of clinically irrelevant DFS-70 positive IFA patterns
• Enzyme-based color development for clear visual interpretation
• Designed for professional in vitro diagnostic use
• CE marked

Intended Use

The DotDiver ANA 18 is a qualitative line immunoassay designed for the determination of IgG antibodies against nuclear and cytoplasmic antigens in human serum, including dsDNA, nucleosomes, Sm, Sm/RNP, ribosomal P0, histones, U1-snRNP, SS-A/Ro60, SS-A/Ro52, SS-B, Scl-70, PM/Scl-100, CENP-A/B, PCNA, Jo-1, M2, DFS-70, and F-actin. The DotDiver ANA 18 is intended as an aid in the diagnosis of systemic inflammatory rheumatic diseases, in conjunction with other clinical and laboratory findings. The immunoassay is optimized for automated use with the DotDiver instrument and designed for professional in vitro diagnostic use.

Diagnostic Relevance

The detection of antibodies in patient serum plays an essential role in the diagnosis of systemic autoimmune diseases. The appearance of antibodies directed against components of the cell nucleus is a characteristic feature of these diseases, particularly systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA), and dermatomyositis. Using the DotDiver ANA 18, laboratories can detect autoantibodies to multiple nuclear and cytoplasmic antigens simultaneously, enabling the identification of characteristic antibody profiles that support the differential diagnosis of systemic autoimmune diseases. Parallel detection of DFS-70 antibodies allows differentiation of positive immunofluorescence assay (IFA) patterns on HEp-2 cells that do not have clinical relevance for rheumatic diseases, enhancing diagnostic accuracy and confidence.

Test Principle

The assay uses ready-to-use breakable test strips coated with highly purified antigens arranged at consistent intervals. When autoantibodies are present, they bind to their corresponding antigens and form immune complexes, which the enzyme-conjugated secondary antibody detects. The enzyme then converts the colorless substrate into a colored, insoluble product, and the signal intensity reflects the antibody activity, allowing laboratory staff to interpret results reliably and qualitatively.