8065 – CytoBead® ANA
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 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.
The Cytobead® is an innovative indirect immunofluorescence immunoassay for the determination of specific antibodies. Tissue sections or cells containing the antigen of interest as well as additional beads coated with specific antigens are immobilized on slides. If specific antibodies are present in the patient´s sample, they bind to the antigen. A secondary antibody conjugated with fluorescein-isothiocyanat (FITC) detects the generated immune complex. The slides are examined using a fluorescence microscope. A specific fluorescent staining pattern demonstrates the presence of specific antibodies in the patient´s sample.
The immunoassay is designed for manual professional in vitro diagnostic use.
|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)|