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The EZER™ H. pylori Antigen Rapid Test is a lateral flow immunoassay for the qualitative detection of Helicobacter pylori antigen in fecal specimens. Optimized for the diagnosis of active infection, the test identifies bacterial antigen at clinically relevant concentrations and provides results within 15 minutes.
Unlike serological antibody testing, which cannot distinguish between past and current infection, stool antigen detection directly reflects ongoing colonization of H. pylori in the gastrointestinal tract. This makes the assay particularly suitable for initial diagnosis and for supporting clinical evaluation when symptoms persist.
Clinical evaluation demonstrated high relative sensitivity, specificity, and overall accuracy when compared with an established immunochromatographic reference method. The combination of speed, reliability, and non-invasive sampling makes this test a practical frontline diagnostic tool for routine gastroenterology testing and outpatient care.
Each kit contains:
20 EZER™ H. pylori antigen test devices
20 stool collection tubes with extraction buffer
1 package insert with instructions
The test detects Helicobacter pylori antigen through immunochromatographic analysis. If H. pylori antigen is present in the stool specimen, a red line appears in the test region (T) along with the control (C) line, confirming a valid positive result.
Helicobacter pylori is a gram-negative bacterium that colonizes the gastric mucosa and infects approximately half of the global population. Persistent infection is a major risk factor for chronic gastritis, duodenal and gastric ulcers, mucosa-associated lymphoid tissue (MALT) lymphoma, and gastric cancer.
Detection of Helicobacter pylori antigen in stool:
Confirms active gastrointestinal infection
Supports differentiation from non-ulcer dyspepsia
Aids clinical decision-making without invasive procedures
Provides actionable results for further diagnostic or therapeutic steps
Because antigen presence reflects current bacterial colonization, stool antigen testing is well suited for non-invasive diagnostic workflows.
Developed by Genesis Biotech, this assay utilizes monoclonal antibodies specific to H. pylori antigens, conjugated to colloidal gold particles. The test is designed for qualitative detection of H. pylori in fecal specimens.
Performance summary:
Sensitivity: 97.9%
Specificity: 98.4%
Overall accuracy: 98.3%
Time to result: 15 minutes
Limit of detection: 1.3 × 10⁵ CFU/mL
No cross-reactivity was observed with a wide range of gastrointestinal bacteria, yeast, or enteric viruses, and common medications and endogenous substances did not interfere with test performance.
Sample type:
Human fecal specimen
Test procedure:
Collect stool sample using the provided collection tube
Mix specimen thoroughly in extraction buffer
Add 3 drops of extracted sample to the cassette
Read results after 15 minutes
Result interpretation:
Positive: Two red lines (C and T)
Negative: One red control line (C only)
Invalid: No control line — retest required
The simple workflow and visual readout support efficient testing in clinical laboratories and decentralized diagnostic settings.
The EZER™ H. pylori Antigen Rapid Test is intended for:
Non-invasive diagnosis of H. pylori infection
Evaluation of patients with dyspepsia or ulcer-related symptoms
Gastroenterology outpatient and laboratory testing
Routine screening where rapid results are required
By combining speed, accuracy, and ease of use, this test supports effective gastrointestinal infection assessment and informed clinical management.
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