Product Name Diagnostic Kit for Helicobacter pylori Antigen (Immunochromatography) Intended Use The reagent is used to detect the HP antigen in human feces qualitatively.Helicobacter Pylori (HP) grows in gastric mucus deep layer, surface of gastric mucosa, and mostly in gastric antrum, gastric pit,epithelial deep fold and gland cavity. There will be a short-term acute gastritis symptom with epigastric pain, nausea, emesis and flatulence after helicobacter pylori enter the stomach. The most common infection is chronic gastric inflammation with no obvious symptoms, which will cause duodenal ulcer and gastric ulcer. HP is a pathogenic factor of stomach cancer, for causing Induction of bacterial proliferation, Changes of gastric mucosa, decrease of hydrochloric acid in gastric juice. Over 90% of duodenal ulcer is found with HP, over 70% of gastric ulcer is found with HP and over 60% of chronic gastritis is associated with HP. Principle The test utilizes antibodies including a HP polyclonal antibody and rabbit anti-mouse IgG antibody (polyclonal antibody) on the nitrocellulose membrane with colloidal gold marked HP antibody as an mark tracer. The reagent is used to detect the HP antigen in sample according to the principle of double antibody sandwich method and gold immunochromatography assay.
Main Components The testing kit is in the form of strip and cassette. Basic components: Sample pad, colloidal gold marked pad, nitrocellulose membrane, absorbent paper and PVC board. Colloidal gold marked pad coated with HP polyclonal antibody, nitrocellulose membrane coated with anti-HP polyclonal antibody,control line coated with goat anti-mouse antibody. The sample dilution is made of phosphate buffer (PBS). Storage and Expiry Store as packaged in the sealed pouch at 4-30°C, avoid hot and sunshine, dry place, valid for 24 months. DO NOT FREEZE. Some protective measures should be taken in hot summer and cold winter to avoid high temperature or freeze-thaw.
Limitation 1. This reagent is designed for the qualitative screening test. Concentration of HP cannot be determined by this qualitative test. 2. The results of the reagent are only for clinical reference, which is not the only basis for clinical diagnosis and treatment. A confirmed diagnosis and treatment should only be made by a physician after all clinical and laboratory findings have been valuated. 3. Negative result does not completely ruled out gastric helicobacter pylori infection, it only indicate that the specific antibodies of the stomach helicobacter pylori does not exist orthe concentration is below detection limit. When HP infectionis still suspected, a bacterial culture or histological analysis diagnosis is suggested.clinical findings.
Manufacturing procedure
Packing & Delivery
Company Profile
Established in Year 2014,CHANGCHUN ZYF SCIENCE AND TECHNOLOGY Co., Ltd. is a high-tech enterprise devoted to the R&D, manufacturing, and sales of high-quality diagnostic products including laboratory equipment and clinical diagnostic reagents.
We can offer more than 30 kinds of urine analysis strips sold well and enjoyed high reputation from both domestic and overseas markets. Based on the principle of "customer first, quality first", our products continue to cover world-wide markets with the advantages of stable performance and high accuracy.
We registered MR International Healthcare Technology Co., Ltd. in Hong Kong for overseas sales. Through MR, we also possess some manufacture facilities in Zhejiang, Guangdong and Jiangsu provinces of China in order to help reduce the cost while caring about the quality.
We are committed to provide most reliable medical devices and solutions to people in every corner of the earth. Accomplishing the mission of "maximizing the reliability of medical products" is our goal. We do care about obtaining the trust from our partners and patients. We are dedicated to innovation in the fields of Rapid Test, POCT, In-Vitro Diagnostics, and Medical Consumables, such as vacuum tubes, tube holders, etc.