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.

Method Principal:

H. pylori Antigen test is a rapid test for the qualitative detection of Helicobacter pylori antigens in human stool. This test kit is intended as an aid in the diagnosis of H. pylori infection in patients with gastrointestinal symptoms. The H. pylori test contains a membrane strip, which is pre-coated with H. pylori capture monoclonal antibodies on test band region. The H. pylori antibody– colloid gold conjugate and extracted stool sample move along the membrane chromatographically to the test region (T) and form a visible line as the antibody-antigen-antibody gold particle complex forms with high degree of sensitivity and specificity. This test device is marked with the letters T (Test Line) and C (Control Line) on the surface of the case. Both the Test Line and Control Line in result window are not visible before applying any samples. The Control Line is used for procedural control. Control line should always appear if the test procedure is performed properly and the test reagents of control line are working.