63,00

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Format

Casette

REF

GTIHP03

Regulatory Status

CE

Sample Type

Feces

Incubation Time

10 min

Description

Helicobacter pylori (H.pylori) is a small, gram-negative, spiral-shaped bacterium that infects the stomach and duodenum and causes for gastrointestinal diseases. H.pylori is found to be the major cause of acute and chronic gastritis, peptic ulcer disease, gastric carcinoma, and lymphoma. Although it is a disease seen all over the world, its prevalence is more common in developing countries. The transmission of H.pylori infection can occur by fecal-oral and oral-oral routes and also contaminated water.

Despite the gnawing and burning epigastric pain, H.pylori infection is commonly asymptomatic. Since then, early diagnosis of the infection plays a crucial role and enables to the prevention of further serious complications by treatment.

For the diagnosis, both invasive and noninvasive methods are used. By HpSA (H.pylori Stool Antigen) testing, it is possible to diagnose the infection and also monitor the treatment efficiency against the H.pylori.

INTENDED USE

The H.pylori Ag Test is a rapid, immunochromato- graphic assay for the qualitative detection of H.pylori antigens in human feces samples to diagnose the H.pylori infection.

• Clean and reliable use, ease of use with the sample collection tube prefilled with diluent.

• The presence of H. pylori Ag indicates that the person is

PERFORMANCE EVALUATION

• Sensitivity :99,9% • Specificity :99,9 %

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