Home Products 8065 – CytoBead® ANA

8065 – CytoBead^® ANA

Intended Purpose

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

The detection of autoantibodies in patient sample, e.g. plasma and serum, is well established and plays an essential role in the diagnosis of systemic autoimmune diseases.

The use of Hep-2 cells in immunofluorescence assay offers a very sensitive screening approach to detect antinuclear antibodies (ANA) directed against components of the cell nucleus. By identifying the staining patterns on HEp-2 cells, the identification of the antigen targeted by ANA and the associated autoimmune disorders is achieved.

Product Specifications

Title	CytoBead^® ANA
Product code	8065
Indication	Systemic autoimmune diseases
Description	Indirect immunofluorescence assay for the determination of IgG antibodies in human serum against nuclear and cytoplasmic antigens
Format	Slides coated with HEp-2 cells as well as with beads coated with the ANA antigens dsDNA, Scl-70, SS-A/Ro60, SS-A/Ro52, SS-B, CENP-B, Sm and Sm/RNP
Total incubation time	60 min.
Sample volume	5 µL serum
No. of determinations	80 (10 x 8)