Background

Helicobacter pylori (H. pylori) is a gram-negative bacterium which infects gastric mucosa. This infection is associated with various gastro-duodenal diseases, as 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 IgA is intended for the determination of IgA 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.