Helicobacter pylori is a spiral bacterium cultured from human gastric mucosa identified 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. Multiple 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. Serologic tests are employed to detect antibodies as human immune response to H. pylori. Two methods appear to be of great interest regarding their use in H. pylori routine serology, namely the ELISA and the Western immunoblot because they offer the most versatility in regards to immunoglobulin specificity and relative ease of use.
Principle of the Test:
Purified H. pylori antigen is coated on the surface of microwells. Diluted patient serum is added to wells, and the H. pylori IgA 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 TMB Chromogenic substrate 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 IgA specific antibody in the sample. The results are read by a microwell reader compared in a parallel manner with calibrator and controls.
Intended Use:
Helicobacter pylori IgA is intended for use in evaluating the serologic status to H. pylori infection in patients with gastrointestinal symptoms.
Specificity: 97.10%
Sensitivity: 88.90%
Kit Components:
Microtiter Plate, 1x96wells
Sample Diluent, 1x22ml
Calibrator, 1x150ul
Negative Control, 1x150ul
Positive Control, 1x150ul
Washing Concentrate (10X), 1x100ml
Enzyme Conjugate, 1x12ml
TMB Substrate, 1x12ml
Stop Solution, 1x12ml
Storage and Stability:
Store all components at 4 degrees C. Stable for 6 months. Reconstituted standards are stable for two weeks stored at 4C. For maximum recovery of product, centrifuge the original vial prior to removing the cap.
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