This test is intended for the qualitative detection of H. pylori antigen in stool samples and is for in vitro diagnostic use only. This test is based on the immunochromatography method.

Summary

H. pylori is a small, spiral-shaped bacterium that lives on the surface of the stomach and duodenum. It causes various gastrointestinal diseases, including duodenal ulcer, gastric ulcer, and gastritis. For the diagnosis of Helicobacter pylori infection in patients with gastrointestinal symptoms, both invasive and non-invasive methods are used. Invasive diagnostic methods include gastric or duodenal biopsy followed by urease testing, culture, and histological staining, which are costly methods. A common method for detecting H. pylori infection is the serological detection of specific antibodies in infected patients. The main limitation of serological testing is its inability to distinguish between current and past infections. Antibodies may remain in the serum for a long time after the disease has been eliminated. The HpSA test (H. pylori Stool Antigen Test) has become increasingly popular for the detection of H. pylori infection and for evaluating the effectiveness of H. pylori infection treatment. Studies have shown that more than 90% of patients with duodenal ulcers and 80% of patients with gastric ulcers are infected with H. pylori. The H. pylori Antigen Rapid Test (Stool) is a chromatographic immunoassay method for the qualitative detection of H. pylori antigens in human stool samples, which can be performed within 10 minutes. In this test, specific antibodies against H. pylori antigens are used for the selective detection of H. pylori antigens in human stool samples

The H. pylori Antigen Rapid Test is an immunochromatographic method for the detection of H. pylori antigen in human stool samples. In this test, the nitrocellulose membrane is coated with anti-H. pylori antibodies in the test region (T). During the test procedure, the sample reacts with particles conjugated with anti-H. pylori antibodies. The complex migrates toward the nitrocellulose membrane by capillary action and reacts with anti-H. pylori antibodies, forming a colored line in the test region (T). The presence of a colored line in the test region indicates a positive test result, while the absence of a colored line indicates a negative test result. As an internal control, a colored line always appears in the control region (C), indicating that an appropriate sample volume has been applied and that the sample has migrated correctly through the nitrocellulose membrane.

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