8220 – CytoBead^® ANA 2

Highlights

• Slides coated with HEp-2 cells and multiplex beads for dsDNA, Scl-70, SS-A/Ro60, SS-A/Ro52, SS-B, Jo-1, Sm, and Sm/RNP
•Multiplex ANA differentiation in a single well
• Ready-to-use reagents for manual processing
• Quality assured handling in routine laboratories
• Consistent processing for parallel use of multiple IF assays
• High diagnostic sensitivity and specificity
• Manual professional in vitro diagnostic use
• CE marked

Intended Purpose

The CytoBead^® ANA 2 is an immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination IgG antibodies in human serum against nuclear and cytoplasmic antigens (dsDNA, Scl-70, SS-A/Ro60, SS-A/Ro52, SS-B,  Sm, Sm/RNP and Jo-1). The CytoBead^® ANA 2 is 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 professional in vitro diagnostic use.

Diagnostic Relevance

The appearance of autoantibodies directed against components of the cell nucleus are characteristic features of systemic autoimmune diseases, especially; systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA) and dermatomyositis.

Detecting autoantibodies in patient samples, such as plasma or serum, plays a key role in diagnosing systemic autoimmune diseases. Using HEp-2 cells in immunofluorescence assays provides a sensitive screening method to detect antinuclear antibodies (ANA). Clinicians can determine the targeted antigen and the associated autoimmune disorder by analyzing staining patterns on HEp-2 cells.

Publications

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