4270 – AKLIDES^® CytoBead^® ANCA

Highlights

• Slides coated with cryostat tissue sections of human ethanol-fixed granulocytes and beads coated with PR3, MPO, and GBM
• Semi-quantitative determination of IgG antibodies against ANCA
• Ready-to-use reagents (exception: PBS buffer)
• Quantitative determination of IgG antibodies against PR3, MPO, and GBM
• Short incubation times at room temperature
• Consistent processing for parallel use of multiple IF assays
• High diagnostic sensitivity and specificity
• CE marked
• Automated evaluation using AKLIDES® or akiron® system

Intended Purpose

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) and glomerular basal membrane (GBM). Clinicians use the AKLIDES® CytoBead® ANCA to aid in diagnosing systemic vasculitis and autoimmune renal disorders, together with other clinical and laboratory findings.The immunoassay is designed for manual processing and automated evaluation using the akiron^® or AKLIDES^® systems. The immunoassay is designed for professional in vitro diagnostic use only.

Diagnostic Relevance

Determination of IgG autoantibodies (AAb) in human serum specific for Proteinase 3 (PR3), Myeloperoxidase (MPO) as well as glomerular basement membrane (GBM) is done with the help of PR3, MPO or GBM coated beads. Ethanol fixed human granulocytes in the same well allow the determination of the fluorescence pattern, cytoplasmic (cANCA) or perinuclear (pANCA). The automated AKLIDES® platform measures the fluorescence intensity of cells and antigen-coated beads. It differentiates cANCA and pANCA patterns on the granulocytes. Standard curves (IU/mL for PR3 and MPO, U/mL for GBM) quantify the specific antibody levels in the serum.

Publications

• Bossuyt et al., (2021) Harmonization of antineutrophil cytoplasmic antibodies (ANCA) testing by reporting test result-specific likelihood ratios: position paper
• Romero-Sánchez et al., (2020) Frequency of Positive ANCA Test in a Population With Clinical Symptoms Suggestive of Autoimmune Disease and the Interference of ANA in its Interpretation
• Sowa et al., (2017) Next-Generation Autoantibody Testing by Combination of Screening and Confirmation-the CytoBead® Technology
• Damoiseaux et al., (2016) Detection of antineutrophil cytoplasmic antibodies (ANCAs): a multicentre European Vasculitis Study Group (EUVAS) evaluation of the value of indirect immunofluorescence (IIF) versus antigen-specific immunoassays
• Sowa et al., (2014) Der CytoBead-Assay – Eine neue Möglichkeit der multiparametrischen Autoantikörperanalytik bei systemischen Autoimmunerkrankungen
• Sowa et al., (2014) Simultaneous automated screening and confirmatory testing for vasculitis-specific ANCA