Helicobacter pylori is a spiral bacterium cultured from human gastric mucosa discovered by B.J. 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 ulcers, non-ulcer dyspepsia, and gastric adenocarcinoma and lymphoma. The organism is present in 95-98% of patients with duodenal ulcers and 60-90% of patients with gastric ulcers. The studies have also demonstrated that removal of the organism by anti-microbial therapy is correlated with the resolution of symptoms and cure of diseases. Patients who present 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 is subject to errors related to sampling and interference of contaminated bacteria. An ELISA test of the presence of H. pylori specific IgG antibody is the technique of choice for serologic tests because of its accuracy and simplicity.
Sample Type:Serum
Intended Use:The Helicobacter pylori IgG Test Kit is intended for use in evaluating the serologic status to H. pylori infection in patients with gastrointestinal symptoms.
Test Principle:Purified H. pylori antigen is coated on the surface of microwells. Diluted patients serum is added to the wells, and the H. pylori IgG-specific antibody, if present, binds to the antigen. All unboundmaterials are washed away. Enzyme conjugate is added, which binds to the antibody-antigen complex. Excess enzyme conjugate is washed off and substrate and chromogen are added. Theenzyme conjugate catalytic reaction is stopped at a specific time. The intensity of the color generated is proportional to the amount of IgG-specific antibody in the sample. The results are read by a microwell reader compared in a parallel manner with calibrator and controls.
Kit Components:Purified H. pylori antigen coated microtiter plate, 1x96 wells
Enzyme Conjugate Reagent (red color), 1x13ml
Sample Diluent (green color), 1x22ml
Negative Control, 1x150ul
Cut-off Calibrator, H. pylori IgG EIA Index = 1, 150ul
Positive Control, 1x150ul
Wash Buffer (20X),1x50ml
TMB Reagent (One-Step), 1x11ml
Stop Solution (1N HCl), 1x11ml.
Storage and Stability:Store all components at 4°C. Stable for at least 6 months. For maximum recovery of product, centrifuge the original vial prior to removing the cap.
