Summary and Principle of the Assay: H. pylori is a small, spiral-shaped gram negative bacterium that lives in the surface of the stomach and duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including peptic ulcers, gastritis, duodenitis, extradigestive diseases and in some cases, cancer. Over 80 percent of individuals infected with the bacterium are asymptomatic and it has been postulated that it may play an important role in the natural stomach ecology. Individuals infected with H. pylori have a 10 to 20% lifetime risk of developing peptic ulcers and a 1 to 2% risk of acquiring stomach cancer. Inflammation of the pyloric antrum will likely to lead to duodenal ulcers, while inflammation of the corpus (body of the stomach) will likely to lead to gastric ulcers and gastric carcinoma. However, it is possible that H. pylori plays a role only in the first stage leading to common chronic inflammation, nut not in further stages leading to carcinogenesis. The continued presence of H. pylori is a risk factor for gastric cancer.
Neotest Rapid HP Antibody Test is an antibody-capture immunochromatographic assay, detecting the presence of H. pylori antibody in human whole blood, serum or plasma samples. Specific H. pylori antigens are 1) conjugated with colloidal gold and deposited on a conjugate pad, and 2) immobilized on the test line on the nitrocellulose membrane. When the whole blood, serum or plasma sample is added, the gold-antigen conjugate is rehydrated and the H. pylori antibodies, if any in the sample, will interact with the gold conjugated antigen. The antigen-antibody-gold complex will migrate towards the test window until the Test Zone (T) where they will be captured by immobilized antigens, forming a visible pink line (Test line) which indicates a positive result. If H. pylori antibody is absent in the sample, no pink line will appear in the Test Zone (T) indicating a negative result.
To serve as an internal process control, a control line should always appear at Control Zone (C) after the test is completed. Absence of a pink control line in the Control Zone (C) is an indication of an invalid result.