H. Pylori Antigen Qualitative Test（Fluorescence Immunoassay）

Clinical Significance:

1. Detection of Active Infection

The test detects H. pylori antigen in stool samples, which indicates current or active infection, rather than past exposure.

Antigen detection reflects active bacterial colonization, making it useful for both initial diagnosis and confirmation of infection status before treatment.

2. Relevance to Disease Burden

H. pylori is a Class I carcinogen and the main pathogenic factor for chronic active gastritis, peptic ulcer, gastric mucosa‑associated lymphoid tissue (MALT) lymphoma, and gastric cancer.

Early and accurate detection enables timely eradication therapy, thereby reducing the risk of long‑term complications, including gastric malignancy.

3. Utility in High‑Prevalence Settings

The bacterium infects more than half of the world’s population, with strong transmission via hands, food, utensils, and feces.

This test is well‑suited for screening in high‑prevalence areas or households, helping to identify infected individuals and interrupt transmission chains.

4. Diagnostic Advantages of the Method

Using a fluorescence immunoassay with double‑antibody sandwich technology, the test provides high specificity and sensitivity.

It allows objective quantitative or semi‑quantitative reading via an immunofluorescence analyzer, reducing subjective interpretation errors compared to conventional rapid tests.

5. Clinical Applications

Diagnosis of H. pylori infection in patients with dyspepsia, gastritis, or peptic ulcer.

Post‑treatment follow‑up (usually ≥4 weeks after completing eradication therapy) to confirm successful eradication, as antigen detection is not affected by recent antibiotic or proton pump inhibitor use as much as other methods (e.g., urea breath test).