The H. pylori Antigen Rapid Test Device (Feces) is a rapid visual immunoassay for the qualitative presumptive detection of Helicobacter pylori antigens in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of H. pylori infection.
The H. pylori Antigen Rapid Test Device (Feces) has been designed to detect Helicobacter pylori through visual interpretation of color development in the internal strip. The membrane was immobilized with anti-H. pylori monoclonal antibody on the test region. During the test, the specimen is allowed to react with colored anti-H. pylori monoclonal antibody colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane.
If there were enough H. pylori antigens in specimens, a colored band will form at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.
- Collect 1-2 drops of venous whole blood / fingertip blood or 1-2ml of venous blood, get the serum or plasma specimen after centrifuging.
- Serum, plasma or whole blood should be placed at 2-8℃ not exceed 7 days, if the detection is arranged after 7 days, the serum, plasma or whole blood should be stored at -20℃ and avoid repeated freezing & thawing.
- Can be used for serum, plasma or whole blood specimen anti-coagulated by sodium citrate, heparin, EDTA.
- Qualitative results in 15 minutes
- 99.28% sensitivity
- 99% accuracy
- Take sample at any time of the day
- Reactive: Positive —- If two colored bands are visible within 20 minutes, the test result is reactive or positive and valid. The test result can be read as soon as a distinct colored band appears in the test area.
- Non-reactive: Negative —- If test area has no color band and the control area displays a colored band, the result is non-reactive or negative and valid.
- Invalid result —- The test result is invalid if a colored band does not form in the control region. The sample must be re-tested, using a new test device.
Storage & Stability:
The test kits can be stored
at room temperature (4 to 30°c) in the sealed pouch to the date of expiration. The test kits should be kept away from direct sunlight, koisture and heat.