Intended Use:The Helicobacter pylori IgM Test Kit is intended for use in evaluating the serologic status to H. pylori.
Introduction: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. All of the testing performed on biopsy samples is subject to errors related to sampling and interference of contaminated bacteria. An ELISA test for the presence of H. pylori specific IgM antibody is the technique of choice for serologic tests because of its accuracy and simplicity.
Test Principle:Purified H. pylori antigen is coated on the surface of microwells. Diluted serum is added to the wells, and the H. pylori IgM specific antibody, if present, binds to the antigen. All unbound materials are washed away. Enzyme conjugate is added, which binds to the antibody-antigen complex. Excess enzyme conjugate is washed off and a solution of TMB Reagent is added. The enzyme conjugate catalytic reaction is stopped at a specific time. The intensity of the color generated is proportional to the amount of IgM-specific antibody in the sample. The results are read by a microwell reader compared in a parallel manner with calibrator and controls.
Kit Components:Antigen-Coated Wells (1 plate, 96 wells), Microtiter Wells coated with purified H. pylori antigenEnzyme Conjugate Reagent (13ml), Contains goat anti-human IgM conjugated to horseradish peroxidase with preservativesSample Diluent (22ml), Contains phosphate buffer with preservativesNegative Control (150ul/vial), Contains H. pylori IgM negative serum with preservativesCut-off Calibrator (150ul/vial), Contains H. pylori IgM weak positive serum with preservatives; H. pylori IgM Index = 1Positive Control (150ul/vial), Contains H. pylori IgM positive serum with preservativesWash Buffer Concentrate (20X) (50ml), Contains phosphate buffer and Tween 20TMB Reagent (11ml), Contains 3, 3’, 5, 5’ tetramethylbenzidine (TMB) stabilized in buffer solutionStop Solution -1N HCl (11ml), Diluted hydrochloric acid
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.
