This test is intended to be used by professionals as a screening test and provides a preliminary test result to aid in the diagnosis of infection with H. pylori.

The H. pylori Ag Rapid Test detects antigen present in the feces by using specific antibodies, which indicates an active H. pylori infection. However, a negative test result does not preclude the possibility of infection with H. pylori. It can also be used to monitor the effectiveness of treatment and the recurrence of an infection, and is not affected by the use of Proton Pump Inhibitors (PPI). It is reported that the seroprevalence of H. pylori in specimens with positive fecal occult blood (FOB) test results is approximately 39.3%. Therefore a specimen that tests positive with an FOB test may also be tested positive with the H. pylori Ag Rapid Test. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device.