in feces specimens to aid in the diagnosis of H. pylori infection.
The test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings.
For professional use only. For in vitro diagnostic use only.
Principle of The Test
The Rapid H.pylori Ag Test Kit employs a lateral flow chromatographic technology to qualitatively detect the H. pylori antigens in fecal specimens. The fecal sample is collected and treated with the extraction buffer. Add the processed specimen into the Test Cassette, the specimen will migrate forward along with the test strips through capillary effect. If the H.pylori is present in the specimen, the H.pylori antigens will be captured and detected on the T line, resulting in purplish red band on the test region, indicating a positive result. If the H.pylori is not present or present at very low levels in the specimen, there is no red line appears in T line position. The “Control Line” (C) is used for procedural control. Control line should always appear if the test procedure is performed properly and the test reagents are working.
Storage and Stability
1. The test device is sensitive to humidity and as well as to heat;
2. Store kit components at 2-30°C, out of direct sunlight;
3. Kit components are stable until the expiration date printed on the pouch or kit box;
4. Use the Test cassette immediately after removing the test device from a foil pouch, the
Test Cassette must be used within 1 hour or discarded.
5. Do not freeze.