4072 – AKLIDES^® pANCA

Highlights

• Slides coated with formalin-fixed human granulocytes
• Screening test to support the diagnosis of systemic vasculitis (SV)
• Ready-to-use reagents (exception: wash buffer)
• Qualitative determination of IgG antibodies against neutrophil cytoplasmic antigens (ANCA)
• Short incubation times at room temperature
• Consistent processing for parallel use of multiple IF assays
• Excellent diagnostic sensitivity and specificity
• Imaging by use of AKLIDES® or akiron® systems
• CE marked

Intended Purpose

The AKLIDES^® pANCA is an immunofluorescence assay (IFA) for the qualitative determination of IgG antibodies in human serum against neutrophil cytoplasmatic antigens (ANCA) on formalin fixed human granulocytes. Clinicians use the AKLIDES® pANCA to help diagnose systemic vasculitis (SV) alongside other clinical and laboratory findings. Technicians perform the immunoassay manually and capture images automatically using the AKLIDES® or akiron^® system. The immunoassay is designed for professional in vitro diagnostic use.

Diagnostic Relevance

Inflammation of blood vessel walls drives the pathogenesis of systemic vasculitis (SV) and causes various morphological changes. The disease can affect both arteries and veins simultaneously. Patients usually present with general symptoms such as exhaustion, fever, and weight loss. The course of the disease varies depending on which types of vessels are involved.

Anti-neutrophil cytoplasmic antibodies (ANCA) play an essential role in the serological diagnosis of SV. Laboratories usually detect these antibodies using indirect immunofluorescence on ethanol-fixed human neutrophils. Technicians distinguish cytoplasmic ANCA (cANCA) from perinuclear ANCA (pANCA) based on the immunofluorescence pattern. Ethanol fixation destroys granular membranes in the neutrophil cytoplasm, allowing positively charged proteins to move to the negatively charged nucleus—this process creates the ANCA screening substrate. Technicians identify cANCA antibodies by a cytoplasmic fluorescence pattern, while they differentiate pANCA antibodies from antibodies to nuclear antigens (ANA), which also produce a (peri)nuclear pattern.

Publications

• Damoiseaux et al., (2012) Automatic Reading of ANCA-Slides Evaluation of the AKLIDES System
• Knütter et al., (2012) Automated interpretation of ANCA patterns-a new approach in the serology of ANCA associated vasculitis
• Roggenbuck et al., (2009) High-sensitivity Detection of AutoAbs Against PR3 by a Novel Third-generation ELISA