ProDetect™ H.Pylori Antigen Rapid Test

ProDetect^TM H. Pylori Antigen Rapid Test is a qualitative membrane-based immunoassay for the detection of H. Pylori antigens in human fecal specimens. The membrane is pre-coated with specific anti-H. Pylori antibodies in the test line region. During testing, the specimen reacts with the particle coated with anti-H. Pylori antibodies to form an antigen-antibody-gold complex. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-H. Pylori antibodies immobilized in the membrane and produce a colored line. The presence of this colored line in the test line region (T), indicates a positive result, while its absence indicates a negative result. An internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control line, regardless of whether there is a test line or not. If the control line (C) does not appear within the testing time, test result is invalid, and the test should be repeated with a new test device.

• The test kit should be stored either at room temperature or refrigerated (2-30°C), away from direct sunlight. Do not freeze the kit or expose the kit to temperatures over 30°C.
• The shelf life of the kit is as indicated on the outer package (24 months from date of manufacture).
• This test kit is stable until the expiration date marked on the outer package and foil pouch. Ensure all test components are at room temperature (15-30°C) before use.
• Perform the test immediately after taking out the test device from the foil pouch.