87061 – cANCA IFA plus

Highlights

• Slides coated with ethanol-fixed human granulocytes
• Screening test to support the diagnosis of systemic vasculitis (SV)
• Detects IgG antibodies against neutrophil cytoplasmic antigens (ANCA)
• Differentiates cANCA (cytoplasmic) and pANCA (perinuclear) patterns
• Ready-to-use reagents (controls, conjugate, diluent, mounting medium)
• Semi-quantitative titer evaluation possible with serial dilution
• High diagnostic sensitivity and specificity
• Manual processing with standard fluorescence microscope (490/520 nm)
• Designed for professional in vitro diagnostic use
• CE-marked

Intended Use

The cANCA IFA plus is an immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum against neutrophil cytoplasmatic antigens (ANCA) on ethanol fixed human granulocytes. The cANCA IFA plus is intended as an aid in the diagnosis of systemic vasculitis (SV) in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

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.

Detecting autoantibodies in patient samples, such as plasma and serum, plays a key role in diagnosing systemic autoimmune diseases. Systemic vasculitis (SV) primarily involves inflammation of blood vessel walls, which leads to morphological changes. Both arteries and veins can be affected simultaneously. Patients usually present with general symptoms such as exhaustion, fever, and weight loss. The disease course varies depending on the type of vessels involved.

Anti-neutrophil cytoplasmic antibodies (ANCA) play an essential role in the serological diagnosis of SV.Laboratories usually determine these antibodies using indirect immunofluorescence on ethanol-fixed human neutrophils. The immunofluorescence pattern distinguishes cytoplasmic ANCA (cANCA) from perinuclear ANCA (pANCA).

Ethanol fixation destroys granular membranes in the neutrophil cytoplasm, allowing positively charged proteins to move to the negatively charged nucleus. This process forms the basis of the ANCA screening substrate. Clinicians identify cANCA antibodies by a cytoplasmic fluorescence pattern, while they must differentiate pANCA antibodies from antinuclear antibodies (ANA), which also show a (peri)nuclear pattern.