PR3 ANCA IgG EULISA

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PR3 antibodies occur in patients with GPA (Granulomatosis with polyangiitis), a systemic vasculitis affecting the respiratory tract. Their specificity is very high, while their sensitivity depends on the phase and activity of the disease. The titer of these antibodies roughly reflects the course of WG and provides a tool to control therapy efficiency.

Product code
211696
Format
ELISA
Tests
Break apart micro titration strips (12x8) 96 wells
Calculation
Qualitative and quantitative
Antigen
PR3 (Proteinase 3)
Units
U/mL
Calibrators
6
Range
0-100 U/mL
Incubation time
30+30+30 min
Detection system
HRP/450 nm
Availability
CE marked. Not for sale in US

Intended use

Enzyme immunoassay for the detection of autoantibodies IgG against PR3.

 

Background

Anti-neutrophil cytoplasmic antibodies (ANCA) are directed against cytoplasmic components of neutrophil granulocytes and monocytes. They have proven to be useful serological markers for a number of systemic, autoimmune mediated vasculitides.

PR3 antibodies occur in patients with GPA (Granulomatosis with polyangiitis), a systemic vasculitis affecting the kidneys and the respiratory tract. Their specificity is very high, while their sensitivity depends on the phase and activity of the disease. The titer of these antibodies roughly reflects the course of WG and provides a tool to control therapy efficiency.

Technical information

The EULISA PR3 ANCA is intended for the quantitative or qualitative determination of IgG antibodies in human serum, directed against PR3. The immobilised antigen is a highly purified preparation of PR3, isolated from human granulocytes. The test is fast (incubation time 30-30-30 minutes) and flexible (break apart wells, ready-to-use reagents). Six calibrators allow quantitative measurements; a negative and a positive control are used to check assay performance.

Kit components and storage of reagents

Contents of the kit

  1. 1 microwell plate, coated with PR3 and hermetically packed in a foil laminate pouch together with a desiccant bag.
  1. Sample buffer, 100 mL, ready-to-use, orange coloured.
  1. Wash buffer, 100 mL, 10 x-concentrate, blue coloured.
  1. 6 calibrators, 2.0 mL each 0, 3.0, 8.0, 18, 45 and 100 U PR3 antibodies (IgG)/mL ready-to-use, gradually blue coloured.
  1. Negative and positive control, 2.0 mL each, ready-to-use, green and red coloured, respectively.
  1. Anti-human IgG HRP conjugate, 14 mL, ready-to-use, red coloured.
  1. Substrate solution, 14 mL, ready-to-use, colourless.
  1. Stop solution (0.5 M H2SO4), 14 mL, colourless, ready-to-use.
  1. Directions for use
  1. Lot-specific certificate of analysis

All kit components are stored at 2 - 8°C.