87161 – pANCA IFA plus

Highlights

• Slides coated with formalin-fixed human granulocytes
• Confirms pANCA positive results found on ethanol-fixed granulocytes
• Ready-to-use reagents (exception: PBS buffer)
• Qualitative determination of IgG antibodies against neutrophil cytoplasmic antigens (ANCA)
• Short incubation times at room temperature
• Screening test to support the diagnosis of systemic vasculitis (SV)
• High diagnostic sensitivity and specificity
• CE marked
• Manual processing for professional in vitro diagnostic use

Intended Purpose

The pANCA IFA plus is an immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum against neutrophil cytoplasmic antigens (ANCA) on formalin-fixed human granulocytes. It helps clinicians in the diagnosis of systemic vasculitis (SV) when used alongside other clinical and laboratory findings. Additionally, the assay confirms pANCA positive results previously detected on ethanol-fixed granulocytes. The immunoassay is designed for manual professional in vitro diagnostic use only.

Diagnostic Relevance

The appearance of autoantibodies directed against components of the cell nucleus are characteristic features of systemic autoimmune diseases, especially; systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA) and dermatomyositis. Clinicians routinely detect autoantibodies in patient samples, such as plasma and serum, to support the diagnosis of systemic autoimmune diseases. In systemic vasculitis (SV), inflammation affects different blood vessel walls and causes morphological changes. The disease can involve both arteries and veins simultaneously. Patients typically experience general symptoms such as exhaustion, fever, and weight loss. The disease course varies depending on which types of vessels are involved.

ANCA Detection and Assay Confirmation

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) by examining 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. The GA Generic Assays pANCA IFA plus assay confirms pANCA positive results previously detected on ethanol-fixed granulocytes.

Publications

• Roggenbuck et al., (2009) High-sensitivity Detection of AutoAbs Against PR3 by a Novel Third-generation ELISA
• 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