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Intended Use
For use in the qualitative detection of IgG antibody to Helicobacter pylori in human serum or plasma. The assay is an adjunct in the diagnosis of infection by H. pylori . The test can be performed manually or with Mago® Plus automated systems.
For In Vitro Diagnostic Use.
Summary
Helicobacter pylori (formerly called Campylobacter pylori ), an organism which is indicated as an etiological agent of active chronic gastritis and a possible contributor to peptic ulceration, possesses an extremely high level of urease activity.
H. pylori was first noticed in 1979 in stomach biopsies from patients with a variety of intestinal ailments. In 1983 the findings were confirmed. The spiral shaped organism was isolated and was found to shield itself from acid by invading the mucus sheathing of the stomach wall. Once in place the organism appears to trigger an inflammation of the lining characteristic of gastritis or, in severe cases, an erosion of the wall that develops into ulcers.
Recent studies of family members of H. pylori -infected children indicate that parents and siblings are infected at significantly higher rates than are controls.
Population-based studies in general show that those groups with the lowest socioeconomic standards have the highest H. pylori infection rates. Institutionalized children where hygienic standards are low have very high infection rates suggesting the possibility of fecal-oral transmission.
The detection of antibodies specific for H. pylori is gaining importance for the diagnosis of chronic gastritis associated with the organism. One study on the urease of H. pylori revealed that the enzyme is cell-bound and has an apparent molecular weight of 600,000.
From these observations, a specific and sensitive EIA for anti- H. pylori antibody directed against the high molecular weight cell-associated proteins (HM-CAP) of H. pylori was developed and patented.
Principle of the Procedure
The Diamedix immuno simplicity® H. pylori HM-CAP® EIA Test Kit utilizes the enzyme immunoassay technique for the detection of antibody to the H. pylori high molecular weight cell-associated proteins (HM-CAP). Patient serum or plasma samples to be assayed for antibody are first diluted and incubated with the purified H. pylori antigen bound to the solid surface of the microwell. If antibody is present in the patient's serum or plasma, antigen-antibody complexes are formed. After washing the unbound serum or plasma from the well, peroxidase conjugated anti-human IgG is added to the well and allowed to incubate. The conjugate will bind to human anti- H.pylori antibodies. After washing the unbound conjugate from the well, substrate is added and incubated. In the presence of bound enzyme, substrate is converted to an end product, resulting in color development. The absorbance of the end product can be read spectrophotometrically at 450nm (reference 620-690), and is directly related to the concentration of IgG antibodies to H. pylori .
Please refer to complete Package Insert for greater detail about the test.
Features & Benefits
Formatted Procedures
