Helicobacter pylori IgG Chemiluminescence ELISA is intended for use in evaluating the serologic status to
H. pylori infection in patients with gastrointestinal symptoms.

Helicobacter pylori is a spiral bacterium cultured from human gastric mucosa by Marshall in 1982. Studies have indicated that the presence of H. pylori is associated with a variety of gastrointestinal diseases including gastritis, duodenal and gastric ulcer, non-ulcer dyspepsia, gastric adenocarcinoma and
lymphoma. The organism is present in 95-98% of patients with duodenal ulcer and 60-90% of patients with gastric ulcers. The studies have also demonstrated that removal of the organism by antimicrobial therapy is correlated with the resolution of symptoms and cure of diseases. Patients who present with clinical symptoms relating to the gastrointestinal tract can be diagnosed for H. pylori infection by two methods; (1)invasive techniques include biopsy followed by culture or histologic examination of biopsy specimen or direct detection of urease activity.(2)non-invasive techniques include urea breath tests and serological methods. All of the testing performed on biopsy samples are subject to errors related to sampling and interference of contaminated bacteria. H. pylori IgG, testing the presence of H. pylori specific IgG antibody is the technique of choice for serologic tests because of its accuracy and simplicity.

Purified H. pylori antigen is coated on the surface of microwells. Diluted patient serum is added to wells,
and the H. pylori IgG specific antibody, if present, binds to the antigen. All unbound materials are washed away. After adding enzyme conjugate, it binds to the antibody-antigen complex. Excess enzyme
conjugate is washed off and substrate A & substrate B mixture is added. The light generated (RLU) is
proportional to the amount of IgG specific antibody in the sample. The results are read by a microwell
luminometer compared in a parallel manner with calibrator and controls.