4281 – AKLIDES® CytoBead® RPGN
The AKLIDES® CytoBead® ANCA is an immunofluorescence assay (IFA) for the semi-quantitative determination of IgG antibodies in human serum against neutrophil cytoplasmic antigens (ANCA), and quantitative determination of IgG antibodies against proteinase 3 (PR3), myeloperoxidase (MPO), glomerular basal membrane (GBM) and double stranded deoxyribonucleic acid (dsDNA). The AKLIDES® CytoBead® RPGN is intended as an aid in the 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 processing and automated imaging using the AKLIDES® or akiron® system.
Worldwide first and fully automated system, AKLIDES® digital fluorescence microscope is used for the standardized imaging and data processing in immunofluorescence tests on glass slides for the automated determination of ANA, ANCA, nDNA, analysis of microparticles (Cytobead®) and for documentation of tissue sections. Controlled by the AKLIDES® Software, the AKLIDES® system has the ability to produce valid standardized analyses and to document immunofluorescence assays electronically to augment daily laboratory routine in the diagnosis of autoimmune diseases.
The immunoassay is designed for professional in vitro diagnostic use only.
|Title||AKLIDES® CytoBead® RPGN|
|Description||Indirect immunofluorescence assay for the determination of IgG antibodies in human serum against neutrophil cytoplasmic antigens (ANCA), the glomerular basement membrane (GBM) and double stranded deoxyribonucleic acid (dsDNA)|
|Format||Slides coated with human ethanol fixed granulocytes as well as with beads coated with Proteinase 3 (PR3), Myeloperoxidase (MPO), Glomerular basement membrane (GBM) and dsDNA|
|Incubation time||60 min.|
|Sample volume||10 µL serum|
|No. of determinations||48 (6 x 8)|