Product Overview

The H. pylori Antigen Test Kit is a lateral flow fluorescence immunoassay designed for detection of Helicobacter pylori antigen directly from stool samples. Detection of H. pylori antigen helps clinicians diagnose active infection and monitor eradication therapy.

Intended Use

For in vitro quantitative detection of H. pylori antigen in stool specimens as an aid in diagnosis of Helicobacter pylori infection.

Clinical Significance

Supports diagnosis of gastritis and peptic ulcer disease, helps identify active H. pylori infection and assists monitoring of treatment effectiveness.

Test Principle

Sandwich fluorescence immunoassay where labelled monoclonal antibodies bind H. pylori antigen forming complexes captured on test line and measured quantitatively by analyzer.

Sample Type

Stool specimen

Test Time

Approximately 10 minutes

Measuring Range

1.0 – 2000 ng/mL

Detection Limit

≤1.0 ng/mL

Technology

Fluorescence Immunoassay

Compatible Analyzers

GETEIN 1100
GETEIN 1160

Storage & Stability

Store at 4–30°C. Test card should be used within 1 hour after opening foil pouch.

Applications

Gastrointestinal infection diagnostics, hospital laboratories, diagnostic centers and gastroenterology clinics.