Scl-70 IgG EULISA

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Antibodies to the Scl-70 autoantigen also recognised as the enzyme topoisomerase 1, are highly specific for patients with Progressive Systemic Sclerosis (PSS, scleroderma) a chronic-inflammatory, autoimmune mediated disorder affecting connective tissue.

Product code
213196
Format
ELISA
Tests
Break apart micro titration strips (12x8) 96 wells
Calculation
Qualitative and quantitative
Antigen
Scl-70
Units
U/mL
Calibrators
6
Range
0-60 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 Scl-70.

Background

Progressive Systemic Sclerosis (PSS, scleroderma) is a chronic-inflammatory, autoimmune mediated disorder of the connective tissue. Its main manifestation is a thickening and hardening of the skin, but inner organs and blood vessels can be affected as well.

PSS patients present characteristic autoantibodies against a variety of nuclear proteins but almost always only one specificity at a time. These antibodies are valuable indicators of different PSS subsets and overlap syndromes with other systemic inflammatory disorders. Depending on the PSS variant, many patients carry antibodies directed against a basic nonhistone protein referred to as Scl-70 (scleroderma-associated 70 kDa autoantigen). It has been identified as DNA-topoisomerase I, a key nuclear enzyme that converts supercoiled DNA to the topological conformation required for DNA replication and transcription.

Scl-70 autoantibodies are considered as reliable marker of PSS. They indicate its severe course (diffuse scleroderma), typically involving lung, kidney or heart.

Technical information

The EULISA Scl-70 IgG is intended for the quantitative or qualitative determination of IgG antibodies in human serum, directed against Scl-70. The antigen used is a highly purified preparation of recombinant human DNA-topoisomerase I, expressed in the baculovirus system. 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 Scl-70 antigen 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, 0.60, 2.0, 6.0, 20 and 60 U Scl-70 (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.