The Easysweet H. pylori Antigen Rapid Test is an in vitro qualitative immunochromatographic assay for the rapid detection of Helicobacter pylori antigens in human stool samples. The test results are designed to help diagnose H. pylori infection, monitor the effectiveness of treatment and confirm the eradication of H. pylori in people with peptic ulcers.
Helicobacter pylori is a spiral-shaped, gram-negative bacillus that lives in the mucus layer of the stomach. H. pylori infection is now considered the most common cause of gastritis and has been implicated etiologically in gastric ulcer, duodenal ulcer, gastric adenocarcinoma, and primary gastric B-cell lymphoma. This organism is very common, infecting at least half of the world's population. Helicobacter pylori infection is usually acquired in childhood. Once acquired, the infection is long-lasting, possibly persisting in the stomach for life. Damage to gastric structure and gastric function is continuous and immediate. About one in six H. pylori infections develop peptic ulcer disease, and a small percentage of H. pylori infections lead to stomach cancer. Diagnostic tests for H. pylori can be divided into two categories: invasive and non-invasive. Direct detection by invasive testing procedures requires endoscopy and biopsy specimens of the gastric antrum and corpus. The presence of H. pylori is then confirmed by direct culture, histological examination or rapid urease test. Endoscopy and biopsy specimens can directly detect active H. pylori infection. Although the procedure is highly specific and has a high positive predictive value, the cost and discomfort to the patient are very high. Probably the most widely used non-invasive tests are serology-based tests. Serological tests detect H. pylori-specific IgG antibodies in the serum of patients with current or previous infection. Serological testing is a simple, convenient and relatively sensitive test. A major limitation of serological testing is the inability to differentiate between current and past infections. Antibodies may be present in patient serum long after eradication of the organism. The urease breath test (UBT) using C or C-labeled urea is a non-invasive test based on the urease activity of an organism. UBT detects active H. pylori infection with high sensitivity and specificity. UBT requires high density and viable bacteria and should not be performed before 4 weeks after treatment to allow residual bacteria to increase to sufficient numbers for detection.
Principle of Easysweet H. pylori Antigen Rapid Test.
Easysweet H. pylori Antigen Rapid Test is a sandwich solid phase immunochromatographic assay. To perform the test, a diluted stool sample is added to the sample well of the test cartridge. The sample flows over a label pad containing H. pylori antibodies conjugated to red colloidal gold. If the sample contains Helicobacter pylori antigen, the antigen will bind to the antibody coated on colloidal gold particles to form an antigen-antibody-gold complex. These complexes move by capillary action on the nitrocellulose membrane towards the area of the test line where the H. pylori-specific antibodies are immobilized. When the complexes reach the detection line, they bind to the antibody on the membrane in the form of a line. A second red control line will always appear in the results window, indicating that the test has been performed correctly and the test equipment is functioning properly. If H. pylori antigen is absent or below the detection limit of the test, only the control line will be visible. If no control line is formed, the test is invalid. See the instructions for use for additional details.
Easysweet also offers other infectious disease rapid tests and infectious disease detection kits. For more information on rapid test kits contact our customer service representatives who will assist you as best as possible.