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  • H. Pylori Antigen Rapid Test
  • H. Pylori Antigen Rapid Test

H. Pylori Antigen Rapid Test

Usage
The H. Pylori Antigen Rapid Test is a rapid, lateral flow chromatographic immunoassay for the qualitative detection of H. pylori antigen in human fecal specimens. It is intended to be used by healthcare professionals as a screening test to aid diagnosis of infection with H. pylori. The test only provides preliminary analysis results but not critical diagnosis criteria. Any use or interpretation of the test must be analyzed and confirmed with alternative testing method(s) and clinical findings based on professional judgment of healthcare providers.

 

Background of Clinical Indications

Helicobacter pylori (H. pylori ) is a small, spiral-shaped bacterium that lives in the surface of the stomach and duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis.1,2 Both invasive and non-invasive methods are used to diagnose H. pylori infection in patients with symptoms of gastrointestinal disease. Specimen dependent and costly invasive diagnostic methods include gastric or duodenal biopsy followed by urease testing (presumptive), culture, and/or histologic staining.3 A very common approach to the diagnosis of H. pylori infection is the serological identification of specific antibodies in infection patients. 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 organisms. HpSA (H. pylori stool antigen) testing is gaining popularity for diagnosis of H. pylori infection and also for monitoring the efficacy of the treatment of H. pylori infection.4 Studies have found that more than 90% of patients with duodenal ulcer and 80% of patients with gastric ulcer are infected with H. pylori.5 The H. Pylori Antigen Rapid Test utilizes specific antibodies to qualitatively detect H. pylori antigens in human fecal specimens. The test can be performed without cumbersome laboratory equipment, and the results are available within 20 minutes.

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Packing specification

Principle of Inspection

The H. Pylori Antigen Rapid Test is a qualitative membrane-based immunoassay for the detection of H. pylori antigens in human fecal specimens. The membrane is pre-coated with specific anti-H. pylori antibodies in the test line region. During testing, the specimen reacts with the particle coated with anti-H. pylori antibodies to form an antigen-antibody-gold complex. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-H. pylori antibodies immobilized in the membrane and produce a colored line. The presence of this colored line in the test line region (T), indicates a positive result, while its absence indicates a negative result. An internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control line, regardless of whether there is a test line or not . If the control line (C) does not appear within the testing time, test result is invalid and the test should be repeated with a new test device.

Specification packaging

25 Tests/Kit, 40 Tests/Kit.

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About Kangte

Zhejiang Kangte Biotechnology Co., Ltd

Zhejiang Kangte Biotechnology Co., Ltd. was established in 2001 and is located in Zhejiang Xinchang Provincial High-tech Industrial Park. It is a national high-tech enterprise integrating R&D, production and sales of in vitro diagnostic reagents. Relying on the pioneering team spirit and scientific management, the company has repeatedly won the national advanced production unit in the in vitro diagnostic industry. 

The company has GMP standard workshops, clean workshops, R&D laboratories, equipped with high-precision testing equipment and fully automatic production equipment. In order to enhance the company's overall R&D strength, it has established a good "production-study-research" cooperative relationship with many colleges and universities. The company has obtained a number of invention patents and utility model patents and has passed ISO9001, ISO14001, ISO13485, and other system certifications. The company currently has more than 100 registered products, covering biochemical, immunological, and other fields, and many of the products have reached the leading domestic level in technology. 

The company adheres to the concept of "integrity, professionalism, efficiency and innovation" to serve customers, and constantly introduces products with higher technological content to provide customers. The company will, as always, position itself in "service technology, professionalism and efficiency, and achieve customers", and work hard to jointly shape the IVD industry and continuously improve the level of human health.

 

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