8260 – CytoBead® ANA DFS-70

The CytoBead® RPGN is an immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum against neutrophil cytoplasmic antigens (ANCA). The CytoBead® RPGN is intended as an aid in the diagnosis of systemic vasculitis as well as autoimmune renal disorders in conjunction with other clinical and laboratory findings.

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. However, not each fluorescent pattern is specific for antibodies related to systemic rheumatic diseases; especially antibodies to the lens epithelium derived growth factor p75, also known as transcriptional coactivator p75 which produce a dense speckled nuclear pattern, accompanied by dense speckled staining of mitotic chromatin. This antigen, also called DFS-70, should be differentiated from those caused by e.g. antibodies to chromatin (dsDNA, histones) or Scl-70, for the differential diagnosis of systemic rheumatic diseases. The use of indirect immunofluorescence on fixated HEp-2 cells further allows the differentiation of dense fine speckled ANA pattern by the use of DFS-70 antigen coated beads.

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.

Product summary

Title CytoBead® ANA DFS-70
Product code 8260
Indication Systemic rheumatic diseases
Description Indirect immunofluorescence test for the determination of antibodies against nuclear and cytoplasmic antigens in human serum
Format Slides coated with HEp-2 cells, as well as beads coated with DFS-70 antigen
Total incubation time 60 min.
Sample volume 5 µL serum
No. of determinations 80 (10 x 8)