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), Sj?gren'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):

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.

2. Sample buffer, 100 mL, ready-to-use, orange coloured.

3. Wash buffer, 100 mL, 10 x-concentrate, blue coloured.

4. Negative and positive control, 2.0 mL each, ready-to-use, green and red coloured, respectively.

5. Anti-human IgG HRP conjugate, 14 mL, ready-to-use, red coloured.

6. Substrate solution, 14 mL, ready-to-use, colourless.

7. Stop solution (0.5 M H2SO4), 14 mL, colourless, ready-to-use.

8. Directions for use

9. Lot-specific certificate of analysis

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