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 Use

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 presence of autoantibodies directed against nuclear and cytoplasmic cellular components is a hallmark of systemic autoimmune diseases. These autoantibodies play a central role in disease pathogenesis and serve as important diagnostic and classification markers. They are particularly associated with disorders such as systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA), and dermatomyositis.

Detection of these autoantibodies in patient serum or plasma represents a cornerstone in the diagnostic evaluation of systemic rheumatic diseases. Indirect immunofluorescence using HEp-2 cells is widely recognized as a highly sensitive screening method for antinuclear antibodies (ANA). The characteristic fluorescence staining patterns observed on HEp-2 cells—such as homogeneous, speckled, nucleolar, or cytoplasmic patterns—provide valuable diagnostic clues and guide further antigen-specific testing.

Identification of specific target antigens such as dsDNA, Sm, Scl-70, SS-A/Ro, SS-B, Sm/RNP, or Jo-1 supports differential diagnosis, helps distinguish between overlapping connective tissue diseases, and may provide prognostic information. Semi-quantitative assessment of antibody levels can also assist in monitoring disease activity and therapeutic response in certain clinical contexts.

By combining sensitive ANA screening with antigen-specific differentiation, the CytoBead® ANA 2 contributes to comprehensive serological evaluation and supports informed clinical decision-making in patients with suspected systemic autoimmune disorders.