The H.pylori Stool Antigen Test is an in vitro qualitative immunochromatographic assay for the rapid detection of Helicobacter pylori antigens in human stool specimen. The test results are intended to aid in the diagnosis of H. pylori infection, to monitor the effectiveness of therapeutic treatment and to confirm the eradication of H. pylori in peptic ulcer patients.

H. pylori Stool Antigen Test is a sandwich solid phase immunochromatographic assay. To perform the test, an aliquot of diluted stool sample is added to the sample well of the test cassette. The sample flows through a label pad containing H. pylori antibody coupled to red-colored colloidal gold. If the sample contains H. pylori antigens, the antigen will bind to the antibody coated on the colloidal gold particles to form antigen-antibody-gold complexes. These complexes move on the nitrocellulose membrane by capillary action toward the test line region on which H. pylori specific antibodies are immobilized. As the complexes reach the test line, they will bind to the antibody on the membrane in the form of a line. A second red control line will always appear in the result window to indicate that the test has been correctly performed and the test device functions properly. If H. pylori antigen is not present or lower than the detection limit of the test, only the control line will be visible. If the control line dose not developed, the test is invalid.

1. 1.Do not pipet reagent by mouth and no smoking or eating while performing assays.
2. 2.Wear gloves during the whole process and avoid reagents or specimen spilling-out.
3. 3.Wipe up the spills using 5% hypochlorite solution.
4. 4.Decontaminate all liquids or solid wastes before deposing.
5. 5.For in-vitro diagnostic use only.
6. 6.Must not use kit beyond the expiration date.
7. 7.Do not mix components from kits with different lot number.
8. 8.Avoid microbial contamination of reagents.

Stool specimens should be collected in containers that do not contain media, preservatives, animal serum or detergents as any of these additives may interfere with the HP Stool Ag Test. Specimens may be stored at 2-8°C for 3 days without interfering with the assay performance. For long-term storage of specimens, -20°C or colder is recommended. Repeated freezing and thawing of specimens is not recommended and may cause erroneous results. Do not store specimens in self-defrosting freezers.

The HP Stool Ag Test can be stored at any temperaturebetween 4-30°C.Do not freeze. The stability of the kit under these storageconditions is 24 months. Use up the reagents as soon as possible after the kit is unpacked within 3 months.