Intended use

Enzyme immunoassay for the detection of autoantibodies IgG against dsDNA, RNP, Sm, Ro (SS-A), La (SS-B), Scl-70, CENP-B 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)/CREST syndrome 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 Profile 8 IgG, eight antigens specifically recognised by these antibodies are immobilised, line by line, on the solid phase (reference: Instructions for use):

Technical information

The test is designed for the individual, qualitative determination of IgG autoantibodies in human serum, directed against one or several of the above antigens. The test is fast (incubation time 30-30-30 minutes) and flexible (8-well strips, 1-12 analyses, ready-to-use reagents). A negative and a positive control are used to check assay performance. The positive control also serves as calibrator for assay evaluation.

Kit components and storage of reagents

Contents of the kit

1. One microwell plate, coated line by line with eight individual autoantigens 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, 3.0 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.