The Rapid H.pylori Antibody Test Kit is a lateral-flow immunoassay for the rapid, qualitative detection of antibodies specific to Helicobacter pylori in human serum, plasma and whole blood. This test is intended for use as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease. The test is intended for use by health care professionals
Principle of The Test
The Rapid H.pylori Antibody Test Kit is composed of a nitrocellulose membrane, which coated with recombinant H.pylori specific Antigen as the test line and goat anti-H.pylori as the controlline, and a conjugate pad containing recombinant H.pylori specific antigens conjugated with Colloidal Gold.
During the test, H.pylori antibody if present in the specimen, migrate through the conjugate pad where they bind to the conjugates. The antibody conjugates are then captured by H.pylori antigens immobilized on T line of the membrane, forming a colored line on the test region (T), indicating a positive result.
Control line should always appear if the test procedure is performed properly and the test reagents are working.
Storage and Stability
1. The Rapid H.pylori antibody test kit should be stored at room temperature (2~30°C).
2. Stable to the indicated expiry date printed on the pouch or kit box when kept in the unopened
pouch at 2~30°C.
3. Do not freeze
Interpretation of the test
Negative
The presence of only control line (“C” line) within the resuit vvindow indicates that
no H.pylori antibodies are detected. The results is negative.