ANA Screen 6 IgG EULISA

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The EULISA ANA Screen 6 IgG is an appropriate first line screen for total anti-nuclear antibody (ANA) in human serum. A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.

Product code
214096
Format
ELISA
Tests
Break apart micro titration strips (12x8) 96 wells
Calculation
Qualitative, summary
Antigen
Antigen mixture
Units
Ratio
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 RNP, Sm, Ro (SS-A), La (SS-B), Scl-70 and Jo-1.

Background

Circulating autoantibodies against various intracellular antigens (antinuclear antibodies, ANA) are characteristic for systemic, autoimmune-mediated rheumatic diseases of the connective tissue. These comprise Systemic Lupus Erythematosus (SLE), Mixed Connective Tissue Disease (MCTD), Sjögren's Syndrome (SS) A and B, Progressive Systemic Sclerosis (PSS, Scleroderma) and Polymyositis (PM).

The diagnosis of the above disorders is often difficult, due to overlapping symptoms, and therefore usually supported by measuring their associated auto-antibodies.

In the EULISA ANA Screen 6 IgG, six antigens specifically recognised by these antibodies are immobilised on the solid phase (Reference: Instructions for use):

Antigen Source Disease

Autoantibody prevalence

RNP (proteins A, C, 68kDa)

Recombinant

MCTD
95 %
    SLE 30 - 40 %
    PM 14 %
    SS 4 %
Sm (proteins B, B', D) Bovine thymus SLE 12 - 39 %
    MCTD 7 %
SS-A/Ro (60kDa-protein) Bovine thymus SS 60 - 100 %
    SLE 45 - 50 %
    MCTD 15 - 30 %
    PSS 5 - 7 %
    PM 5 - 7 %
SS-B/La Recombinant SS 30 - 90 %
    SLE 15 - 30 %
    MCTD 5 - 15 %
Scl-70 (DNA-topoisomerase 1) Recombinant PSS 20 - 76 %
Jo-1 (Histidyl-tRNA-synthetase) Recombinant PM 20 - 40 %

Technical information

The test is designed for the qualitative determination of the combined autoantibodies (IgG) reactivity in human serum, without distinction between different specificities. It is intended as an initial screen test for an overall diagnosis of the above disorders. The test is fast (incubation time 30 / 30 / 30 minutes) and flexible (break apart wells, ready-to-use reagents). 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 a mixture of antigens 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. 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.