HELICOBACTER PYLORI ANTIGEN ELISA KIT
INTENDED USE
This Helicobacter Pylori Antigen ELISA Kit Assay is a sandwich ELISA for determination of Helicobacter pylori in stool. The test kit is for in vitro diagnostic use only.
INTRODUCTION
Helicobacter pylori is regarded as a causative factor for chronic B-gastritis, drug-unrelated ulcus duodeni, and as an etiologic stimulus of gastric MALTlymphoma. Furthermore, it is suspected of being involved in the pathogenesis of stomach carcinoma.
The epidemiology of infection by Helicobacter pylori has been characterized in western industrial nations by a linear increase with age increasing and in developing countries by a large number of children and juveniles being affected. The currently used methods for the diagnosis of Helicobacter pylori infection are very sensitive and highly specific, but all include either invasive sampling or require special technical devices.
This Helicobacter Pylori Antigen ELISA Kit have developed for the detection of Helicobacter pylori infection from faecal samples. This cost-efficient methodology provides a reliable result without the loss of sensitivity or specificity and does not require invasive sampling.
PRINCIPLE OF THE TEST
Helicobacter Pylori Antigen ELISA Kit
Helicobacter Pylori Antigen ELISA Kit is a sandwich ELISA for determination of Helicobacter pylori in stool. A microtiter plate is coated with polyclonal antibodies specific for Helicobacter pylori which bind Helicobacter pylori from the patient sample in a first incubation step. After a washing step, the bound antigen, Helicobacter pylori, is incubated with a biotin-labeled antibody. After a further washing step, a peroxidase-labeled streptavidin is added. Then a chromogenic substrate (TMB) is added, followed by a stop solution. The color changes from blue to yellow. The intensity of the color is proportional to the amount of analyte (sample or control). The results are evaluated by comparison with a cut-off value.
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