Intended use

This device is intended to be used for the in vitro qualitative detection of Helicobacter Pylori (H. pylori) antigen in human feces. And it is for professional use only, not for self-testing of untrained individuals, nor for near-patient testing.

Summary

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. 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 Non-invasive techniques include the urea breath test, which requires expensive laboratory equipment and moderate radiation exposure, and serological methods.

The current clinical methods for detecting H. pylori include chemiluminescence, immunochromatography and so on.

PRODUCT PARAMETER

TEST INFORMATION
Method	Microfluidic Fluorescent Immunoassay	Test	LYOFIA® HP-Ag
Format	Cassette	Reaction Time	10min
Linearity	-	Reference	Negative ≤ 1 Positive > 1
Sample	Feces	Certificate	CE

ORDERING
Cat. No.	LMGFHG25	Applicable analyzer	LYOFIA-I, LYOFIA 8,	Kit Size	25T
Cat. No.	LAGFHG25	Applicable analyzer	LYOFIA 100 (Full-Automatic)	Kit Size	25T