8066 – CytoBead® RPGN
Intended Purpose
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 immunoassay is designed for manual professional in vitro diagnostic use.
Diagnostic Relevance
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).
Product Specifications
| Title | CytoBead® RPGN |
| Product code | 8066 |
| Indication | Systenic vasculitis and autoimmune renal disorders |
| Description | Indirect immunofluorescence assay for the determination of IgG antibodies in human serum against neutrophil cytoplasmic antigens (ANCA) and the glomerular basement membrane (GBM) |
| Format | Slides coated with ethanol fixed human granulocytes as well as with beads coated with proteinase 3 (PR3), myeloperoxidase (MPO) and glomerular basement membrane (GBM) |
| Total incubation time | 60 min. |
| Sample volume | 10 µL serum |
| No. of determinations | 48 (6 x 8) |