87261 – ANCA IFA dual

Highlights

• Slides coated with ethanol- and formalin-fixed human granulocytes
• Screening test to support the diagnosis of systemic vasculitis (SV)
• Ready-to-use reagents (exception: wash buffer)
• Quality assured handling in routine laboratories
• Short incubation times (30 min / 30 min) at room temperature
• Consistent processing for parallel testing of multiple ANCA samples
• Excellent diagnostic sensitivity and specificity for cANCA and pANCA
• Manual processing for professional in vitro diagnostic use
• CE marked

Intended Use

The ANCA IFA dual 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 and formalin fixed human granulocytes. The ANCA IFA dual 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 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. Detecting autoantibodies in patient samples, such as plasma or serum, is well established and plays a key role in diagnosing systemic autoimmune diseases. Systemic vasculitis (SV) primarily develops through inflammation of blood vessel walls, which leads to characteristic morphological changes. Both arteries and veins can become affected at the same time. Patients typically present with general symptoms such as fatigue, fever, and weight loss. The disease course 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 determine 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 neutrophil cytoplasm, allowing positively charged proteins to move into the negatively charged nucleus, which serves as the basis for 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. Laboratories use GA Generic Assays pANCA IFA plus to confirm pANCA-positive results detected on ethanol-fixed granulocytes.