FLUORO ANCA TEST

IVD-In Vitro Diagnostic Use CE marked

Instructions for use

The FLUORO ANCA TEST is intended for detection of anti-neutrophil cytoplasmic antibodies (ANCA) in human serum.

Background:

In 1982 Davis et al. described the presence of antineutrophil cytoplasmic antibodies (ANCA) in serum of patients with necrotising glomerulonephritis. This was followed in 1985 with a publication by van de Woude et al. who found that 25 out of 27 patients with active Wegener's granulomatosis exhibited the classical cytoplasmic (C-ANCA) staining pattern in indirect immunofluorescence. The classical C-ANCA pattern on ethanol-fixed neutrophils shows characteristic granular cytoplasmic staining with minimal staining of the nuclear lobes. The major C-ANCA target antigen is proteinase III, a serine protease. A second ANCA staining pattern (perinuclear, P-ANCA) was described in 1988 by Falk et al. in renal patients with systematic vasculitis. The major P-ANCA target antigen is thought to be myeloperoxidase, although several other antigens (lactoferrin, elastase, cathepsin G) are associated to lesser degree. The P-ANCA pattern on ethanol-fixed neutrophils shows sharply delineated perinuclear staining.
The FLUORO ANCA TEST, with ethanol and formalin fixed human neutrophils as substrate, is reagent for the detection of antineutrophil cytoplasmic antibodies (ANCA) in human serum.

Principle:

The FLUORO ANCA TEST uses an indirect immunofluorescence technique where patient samples and appropriate controls are incubated with the neutrophil substrates. The unreacted antibodies are washed off and then an appropriate fluorescein labelled conjugate is applied. Unbounded conjugate is washed off as before. Slides are viewed with a fluorescent microscope and positive samples are seen as apple green fluorescence which corresponds to areas of the neutrophil where antibody has bound.

Size: 50 wells (5 wells x 10 slides)

Method: IIF

Substrate: Ethanol fixed neutrophil(Code No. 4710E)/Formalin fixed neutrophil(Code No. 4720E,for confirmation)

Availability: all regions