8066 – CytoBead® RPGN

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 glomerular basement membrane (GBM) and double stranded deoxyribonucleic acid (dsDNA). 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 detection of antibodies against neutrophil cytoplasmic antigens (ANCA), the glomerular basement membrane (GBM) and double stranded deoxyribonucleic acid (dsDNA) is used for the differential diagnosis of ANCA associated vasculitis (AAV) and systemic vasculitis (Granulomatosis with Polyangiitis – GPA, Microscopic Polyangiitis – MPA, Eosinophilic Granulomatosis with Polyangiitis – EGPA). It is also employed for the diagnosis of autoimmune kidney diseases (Good pasture syndrome, Rapidly Progressive Glomerulonephritis – RPGN and SLE associated nephritis).

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.