The One-Step H. pylori Fecal Antigen Assay is a rapid, visual immunochromatographic assay for the qualitative detection of Helicobacter pylori antigen in fecal samples. This test is intended as an aid in the diagnosis of H. pylori infection, and is recommended for professional use.

Helicobacter pylori are gram-negative bacteria that infect gastric mucosa. Infection with H. pylori may lead to chronic gastritis and predispose to gastric and duodenal ulcers. Infection with H. pylori is very common and has been estimated to occur in 40-50% of the population in developed countries and 80-90% of the population in developing regions.

The One-Step H. pylori Fecal Antigen Assay has been designed to detect H. pylori antigen in human fecal samples through visual interpretation of color development in the test device. The test device contains a membrane strip, which is pre-coated with anti-H. pylori antibody at the Test Line region (T) and goat anti-mouse antibody at the Control Line region (C). An anti-H. pylori antibody color particle conjugate pad is located at the end of the membrane. When H. pylori antigen is present in the patient's fecal sample and dissolved in buffered saline, the mixture of colloidal gold conjugate and extracted sample moves along the membrane chromatographically by capillary action. This mixture migrates to the Test region (T) and forms a visible line as the antibodies complex with the H. pylori antigen. If H. pylori are not present in the extracted sample, no visible color band will form at the Test region (T). A colored band will always appear at the Control region (C) to serve as a procedural indicator for the proper performance of the test and the device.