Intended Use:

Test for qualitative detection of Helicobacter pylori antigen in stool sample.

Introduction:

H. pylori is the principle etiologic agent in type B gastritis (chronic active antral gastritis) pathology for which it appears to be the triggering and perhaps aggravating factor. Increasing data are being accumulated regarding the fundamental role of H. pylori in active chronic gastritis, in gastric ulcer and in duodenal ulcer and its close correlation with gastric lesions. H. pylori is isolated in culture medium and examined by microscopy after staining or is detected by urease test. Both these techniques are lengthy to implement and their sensitivity and specificity have yet to be demonstrated. The immunochromatographic techniques (rapid) for the detection of antibodies specific to H. pylori has substantially resolved these problems, ensuring a serological monitoring in a very short space of time using simple, highly specific technology without recourse to invasive techniques. The stool test for H. pylori can be utilized as a rapid screening process for large populations of patients and highly indicated in the early diagnosis of H. pylori infection as the immune response can often precede clinical manifestations of disease. From a diagnostic point of view, a high stool-level antigen against H. pylori must be interpreted as an indication of type B asymptomatic gastritis.