Beta2-Glycoprotein-1 IgG EULISA

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The EULISA ß2-Glycoprotein-1 IgG is intended for determination of IgG antibodies against ß2-Glycoprotein in human serum. The occurrence of these antibodies is associated with anti-phospholipid syndrome (APS), an autoimmune disorder characterised by thrombosis in both arteries and veins. Antibodies against ß2-Glycoprotein are also believed to be directly involved in the pathogenesis of APS.

Product code
212496
Format
ELISA
Tests
Break apart micro titration strips (12x8) 96 wells
Calculation
Qualitative and quantitative
Antigen
ß2-GP-1
Units
U/mL
Calibrators
6
Range
2-100 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 ß2-Glycoprotein-1.

Background

The anti-phospholipid syndrome (APS) is an autoimmune disorder which can comprise clinical conditions such as venous and arterial thrombosis, thrombocytopenia, myocardial infarction, recurrent spontaneous abortion and neurological complications.

Cardiolipin (CL) is a common, negatively charged, acid phospholipid. Autoantibodies associated with APS are directed not only against CL and similar phospholipides but also against phospholipid/protein complexes. ß2-glycoprotein 1 (ß2-GP-1; = apolipoprotein H) has been identified as a natural and essential co-antigen for CL-autoantibodies. The occurrence of CL/ß2-GP-1 autoantibodies is associated with a tendency towards thrombosis. Besides this diagnostic significance, these antibodies are believed to be directly involved in the pathogenesis of APS.

Technical information

The EULISA ß2-Glycoprotein-1 IgG is intended for the quantitative or qualitative determination of IgG antibodies in human serum, directed against ß2-GP-1. The immobilised antigen is a highly purified preparation of human ß2-GP-1.

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 ß2-GP-1 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 ß2-GP-1-Ab (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.