Intended use

Enzyme immunoassay for the detection of autoantibodies IgG against Helicobacter pylori.

Background

Helicobacter pylori (H. pylori) is a gram-negative bacterium which infects gastric mucosa. This infection is associated with various gastro-duodenal diseases, like active chronic gastritis and gastric and duodenal ulcers. In addition, evidence has been accumulated that H. pylori infection increases the risk of gastric carcinoma. Serological testing for H. pylori antibodies is a well established method for the diagnosis of this infection.

Technical information

The EULISA Helicobacter pylori IgG is intended for the determination of IgG antibodies in human serum, directed against H. pylori. It may be used qualitatively for pre-endoscopy screening or quantitatively for therapy monitoring. The immobilised antigen is a purified extract from H. pylori ATCC-strain 43504, consisting of specific, native cell surface antigens, including the key antigen urease. Further, the preparation contains the Cag-A protein, coded by the cytotoxin-associated gene A, which is expressed only by the virulent strains of H. pylori.

The test is fast (incubation time 30-30-30 minutes) and flexible (break apart strips, 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 selected H. Pylori 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. 6 calibrators, 2.0 mL each 0, 3.0, 10, 30, 100 and 300 U H. pylori antibodies (IgG)/mL ready-to-use, gradually blue coloured.

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

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

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

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

9. Directions for use

10. Lot-specific certificate of analysis

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