Nanjing Synthgene Medical Technology Co., Ltd

【Product name】H. Pylori Antigen Rapid Test Kit (Colloidal gold method) 

【Packaging specification】1 test/bag, 1/5/10/25/50 Test(s) /Kit

【Intended use】

This product is used for the qualitative detection of Helicobacter pylori (H. pylori) 

antigen in human stool samples. H. pylori is a Gram-negative microaerophilic 

bacterium that lives in the stomach and duodenum, and its infection is very 

common, with a global infection rate of more than 50%. Almost all patients with H. 

pylori infection have active inflammatory reaction histologically. H. pylori infection 

is an infectious disease that can lead to chronic gastritis, peptic ulcers, etc. Common 

symptoms include upper stomach discomfort and pain, flatulence, anorexia, nausea, 

vomiting, and dark or tar-colored stools. About 70% of those infected have no 

obvious symptoms. H. pylori is the main pathogenic factor of gastritis and peptic 

ulcer, and is closely related to the occurrence of functional dyspepsia, gastric 

mucosa-associated lymphoid tissue (MALT) lymphoma and gastric cancer. The 

International Agency for Research on Cancer has classified it as a class I carcinogen. Eradication of H. pylori significantly reduces the incidence of gastric and 

duodenal diseases, as well as gastric cancer, and may reduce new cases of H. pylori

infection in the future. Combined with clinical and other laboratory indicators, this 

product is used for the auxiliary diagnosis of H. pylori infection. This product is 

suitable for professional medical personnel to test in medical units.

The diagnostic methods of H. pylori infection can be divided into two categories 

according to the invasiveness of the sampling method, namely invasive detection 

methods and non-invasive detection methods. The former refers to the detection 

methods that rely on gastroscopic sampling, including histological detection (such 

as HE staining, Warthin-Starry silver staining, modified Giemsa staining, toluidine 

blue staining, acridine orange staining, immunohistochemical 

staining, etc.), bacterial culture, rapid urease test (RUT) and nucleic acid detection for H. pylori; the latter includes serological (antibody) testing, stool Helicobacter pylori antigen 

testing, genetic testing, and urea breath test (UBT).

【Testing principle】

The product adopts the principle of colloidal gold and immunochromatography 

technology. When there is Helicobacter pylori antigen in the sample, the 

Helicobacter pylori antigen in the sample reacts with the colloidal gold-labeled 

antibody (Helicobacter pylori monoclonal antibody 1) on the binding pad to form a 

labeled antigen-antibody complex. The complex is chromatographed upwards by 

capillary action and is captured by a detection line (T line) antibody (H. pylori

monoclonal antibody 2) coated on a nitrocellulose membrane, and a red band 

appears. The complex continues to be chromatographed upwards and is captured by 

a quality control line (C line) antibody (goat anti-chicken IgY antibody) coated on a 

nitrocellulose membrane, and a red band appears. When the content of the analyte 

in the sample is lower than the minimum detection limit , the detection line (T line) 

does not develop color.

【Main components】

1. Test pad, individually packaged in aluminum foil bag (1 piece/bag, 1/5/10/25/50 

piece(s)/kit)

2. Sample diluent (1 piece/bag, 1/5/10/25/50 piece(s)/kit)

3. Instruction manual (1 copy/bag, 1 copy/kit)

Note: The components in different batch numbers of kits are not interchangeable.