5020 – DotDiver Quantrix ANA

Highlights

• Use of highly purified nuclear and cytoplasmic antigens immobilized on dot strips
• Quantitative dot immunoassay for the determination of ANA IgG in human serum
• Broad ANA profile covering 25 clinically relevant autoantigens
• Supports the diagnosis of systemic autoimmune diseases in combination with clinical and laboratory findings
• Calibrator-based quantification with defined AU/mL values for objective result interpretation
• Ready-to-use reagents for efficient routine laboratory workflows
• Reliable and reproducible results suitable for monitoring disease activity
• Suitable for routine laboratory testing
• CE marked

Intended Use

The DotDiver Quantrix ANA is a quantitative dot immunoassay for the determination of IgG antibodies against nuclear and cytoplasmic antigens (nucleosomes, dsDNA, histones, Sm, RNP, Sm/RNP, SS-A/Ro60, SS-A/Ro52, SS-B, Scl-70, Ku, PM/Scl-100, Mi-2, Jo-1, PL-7, PL-12, SRP, ribosomes, CENP-A/B, PCNA, sp100, gp210, M2 recombinant, M2/nPDC and f-actin) in human serum.

The Assays is intended as an aid in the diagnosis and differentiation of systemic autoimmune diseases when used in conjunction with clinical presentation and other laboratory findings. The quantitative format allows objective assessment of antibody levels and supports consistent interpretation of results in routine diagnostics. The immunoassay is designed for semi-automated use with the DotDiver instrument and for professional in vitro diagnostic use.

Diagnostic Relevance

In systemic autoimmune diseases, the body produces autoantibodies that target nuclear and cytoplasmic cellular components. These autoantibodies represent key serological markers and reflect underlying immune dysregulation.

Anti-nuclear antibodies (ANA) occur frequently in diseases such as systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA), and dermatomyositis. Specific ANA profiles provide valuable information for disease differentiation, risk stratification, and clinical assessment.

The detection and quantification of ANA IgG in patient serum is well established in autoimmune diagnostics. Quantitative ANA testing supports diagnostic decision-making, facilitates longitudinal monitoring, and contributes to the evaluation of disease activity and progression when interpreted in the appropriate clinical context.