Helicobacter. Pylori Antigen Rapid Test

​Helicobacter. Pylori Antigen Rapid Test is a corkscrew-shaped, gram-negative rod that lives in the mucous layer of the stomach. H. pylori infection is now accepted as the most common cause of gastritis, and is etiologically involved in gastric ulcer, duodenal ulcer, gastric adenocarcinoma and primary gastric B-cell lymphoma.1,2 The organism is very common, infected at least half of the world’s population. H. pylori infection is typically acquired in childhood. Once acquired, infection persists chronically, probably continuing in the. stomach throughout life. The damage to gastric structure and function of stomach is constant and direct. Approximately one in six of H. pylori infection develops peptic ulcer disease and a small portion of H. pylori infection leads to gastric cancer.3 The diagnostic tests for H. pylori can be classified into two categories: Invasive and Noninvasive tests. Direct detection by invasive test procedures requires an endoscopy and biopsy specimens from antrum and stomach body.4 The presence of H. pylori is then confirmed by direct culture, histological examination or rapid urease test. The endoscopy and biopsy specimens offer direct detection of active H. pylori infections. Although the procedure is highly specific and high positive predictive value, the cost and discomfort to the patients are very high. The most widely available noninvasive test is probably the serological based test. The serology test detects H. pylori specific IgG antibody in patient serum with current or prior infection.5,6 Serology test is a simple, convenient test with relative high sensitivity. The main limitation of serology test is the inability to distinguish current and past infections. Antibody may be present in the patient’s serum long after eradication of the organism.6 The urease breath test (UBT) with 14C or 13C labeled urea, is a noninvasive test based on the urease activity of the organism. UBT detects active H. pylori infection and is highly sensitive and specific. The UBT requires a high density and active bacteria and should not be performed until 4 weeks after therapy to allow residual bacterial to increase to a sufficient number for detection.7

H. pylori Antigen Test is an imunochromatographic assay that uses antibody- coated colloidal gold to detect the presence of H. pylori antigens in stool specimens. The test detects directly antigens in specimens for an active infection. The test is simple and easy to perform and the test results can be visually interpreted within 15 minutes

MAIN CONSTITUENT

1. Test Cassette: 20 test / box
Test Strip: 50 tests / box
2. Sample collection tube with diluent 1ml ×20 for cassette
Sample diluent 30ml×1 for strip
3. Product instruction: 1

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world