4472 – AKLIDES® ANCA dual

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.

Systemic vasculitis (SV) pathogenesis is majorly identified by the inflammation of different blood vessel walls, and the resulting morphological changes. Arteries and veins can both be affected simultaneously. The clinical manifestation is mainly indicated by general symptoms like exhaustion, fever and weight loss. Depending on which kind of vessels are affected, future disease course varies.

Anti-neutrophil cytoplasmic antibodies (ANCA) play an essential role in the serological diagnosis of SV. These antibodies are usually determined by indirect immunofluorescence using ethanol fixed human neutrophils. Cytoplasmic ANCA (cANCA) and perinuclear ANCA (pANCA) are distinguished based on the immunofluorescence pattern. Cell fixation using ethanol destroys granular membranes in neutrophil cytoplasm, thus allowing positively charged proteins move to the negatively charged nucleus – the basis for ANCA screening substrate. cANCA antibodies are identified by a cytoplasmic fluorescence pattern, whereas pANCA antibodies must be differentiated from antibodies to nuclear antigens (ANA) which also show a (peri) nuclear pattern.

The immunoassay is designed for manual processing and automated imaging using the AKLIDES® or akiron® system.

Worldwide first and fully automated system, AKLIDES® digital fluorescence microscope is used for the standardized imaging and data processing in immunofluorescence tests on glass slides for the automated determination of ANA, ANCA, nDNA, analysis of microparticles (Cytobead®) and for documentation of tissue sections. Controlled by the AKLIDES® Software, the AKLIDES® system has the ability to produce valid standardized analyses and to document immunofluorescence assays electronically to augment daily laboratory routine in the diagnosis of autoimmune diseases.

The immunoassay is designed for professional in vitro diagnostic use.