4472 – AKLIDES^® ANCA dual

Highlights

• Slides coated with ethanol and formalin fixed human granulocytes
  
• Specific detection of IgG antibodies against neutrophil cytoplasmatic antigens (ANCA)
• Support for the diagnosis of systemic vasculitis
• Qualitative and semi-quantitative determination of the IgG antibodies
• 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 the parallel use of multiple AKLIDES^® IF assays
• Excellent diagnostic sensitivity and specificity
• Imaging by use of akiron^® or AKLIDES^® systems
• CE marked

Intended Use

The AKLIDES^® ANCA dual is an immunofluorescence assay (IFA) for the qualitative determination of IgG antibodies in human serum against neutrophil cytoplasmatic antigens (ANCA) on ethanol and formalin fixed human granulocytes. The AKLIDES^® ANCA 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 processing and automated imaging using the akiron^®  or AKLIDES^® system. The immunoassay is designed for professional in vitro diagnostic use only.

Diagnostic Relevance

Systemic vasculitis (SV) involves inflammation of blood vessel walls and the resulting morphological changes. The disease can affect arteries and veins simultaneously. Patients typically present with general symptoms such as fatigue, fever, and weight loss. The course of the disease depends on the type and size of the affected vessels.

Anti-neutrophil cytoplasmic antibodies (ANCA) play an essential role in the serological diagnosis of SV. Laboratories usually determine these antibodies by indirect immunofluorescence using ethanol-fixed human neutrophils. Based on the immunofluorescence pattern, clinicians distinguish between cytoplasmic ANCA (cANCA) and perinuclear ANCA (pANCA). Ethanol fixation destroys the granular membranes in the neutrophil cytoplasm and allows positively charged proteins to migrate toward the negatively charged nucleus, which forms the basis of the ANCA screening substrate. A cytoplasmic fluorescence pattern indicates cANCA antibodies, whereas laboratories must differentiate pANCA antibodies from.