4277 – AKLIDES^® CytoBead^® ANA 2

Highlights

• Slides coated with HEp-2 cells and beads coated with dsDNA, Scl-70, SS-A/Ro60, SS-A/Ro52, SS-B, Jo-1, Sm, and Sm/RNP
• Supports the diagnosis of systemic autoimmune diseases
• Ready-to-use reagents (exception: PBS buffer)
• Quality assured handling in routine laboratories
• Consistent processing for parallel use of multiple IF assays
• High diagnostic sensitivity and specificity
• Automated imaging using AKLIDES® or akiron®NEO systems
• CE marked

Intended Purpose

The AKLIDES^® CytoBead^® ANA 2 is an immunofluorescence assay (IFA) for the semi-quantitative determination of IgG antibodies against nuclear and cytoplasmic antigens (ANA) and quantitative determination of IgG antibodies against dsDNA, Scl-70, SS-A/Ro60, SS-A/Ro52, SS-B, Jo-1, Sm and Sm/RNP in human serum. The AKLIDES^® CytoBead^® 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 manual processing and automated imaging using the akiron^® or AKLIDES^® systems. The immunoassay is designed for professional in vitro diagnostic use only.

Diagnostic Relevance

The appearance of autoantibodies directed against components of the cell nucleus is a characteristic feature of systemic autoimmune diseases, especially; SLE, Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA) and dermatomyositis. Clinicians routinely detect autoantibodies in patient samples such as plasma and serum, and this testing plays a key role in diagnosing systemic autoimmune diseases. Determination of these autoantibodies using AKLIDES^® CytoBead^® ANA 2 indirect immunofluorescence on fixated HEp-2 cells allows further ANA differentiation of relevant antigens via multiplex bead technology in one well.

Publications

• Roei et al., (2025) CytoBead ANA 2 assay - a novel method for the detection of antinuclear antibodies