Singclean

Primary DI

06936020140713

Basic UDI-DI Code

B-06936020140713

Reference

HP-02-20t

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Hangzhou Singclean Medical Products Co., Ltd.

[INTENDED USE] Helicobacter Pylori Antigen Test Kit (Immunochromatography) is a rapid chromatographic immunoassay for the qualitative determination of helicobacter pylori antigen in human feces. It is used for the aid to diagnosis of Helicobacter pylori infection. [INTRODUCTION] Helicobacter pylori (Hp) is gram-negative aerobic bacteria in small amounts residing in the stomach and duodenum. Hp infection is seen widespread in over 50% of population around the globe presumably via oral transmission. HP infection is an infectious disease that can cause chronic gastritis and peptic ulcer. Common symptoms include upper stomach discomfort and pain, flatulence, anorexia, nausea, vomiting, as well as dark or tar-colored stool, of which 70% of patients bear no various symptom. Hp is the main cause of gastritis and peptic ulcer, and is closely related to functional dyspepsia, MALT lymphoma, and gastric cancer. The WHO International Agency for Research on Cancer (IARC) has included Hp under Class I carcinogens. Eradication of Hp can significantly reduce the risk of gastric and duodenal diseases, including gastric cancer, and can decrease new Hp infections in the future. Currently, the standard adopted for Hp detection is bacterial isolation and culture technology, but it is hard to be popularized because of its demanding experimental conditions and technical requirements. In contrast, Helicobacter Pylori Antigen Test Kit (Immunochromatography) needs no costly equipment and is characterized by convenient operation procedures and interpretation of results, good sensitivity and specificity, which makes it increasingly popular.

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