Optimization
CE-IVD Certified Non-Invasive Gastric Assay

H. Pylori Antigen
Rapid Test (Feces)

Gold-standard non-invasive rapid chromatographic immunoassay for the direct qualitative detection of active Helicobacter pylori antigens in human stool specimens. Essential for initial gastric ulcer diagnosis and definitive post-treatment eradication confirmation in 10 minutes.

Readout Time 10 Minutes
Specimen Type Stool / Feces
Clinical Accuracy 98.6% Agreement
Storage / Shelf Life 2°C – 30°C (24 Mos)
QuRapid HP-Ag Device CE-IVD Marked
H. Pylori Antigen Window
S
C — Internal Procedural Control
T — H. Pylori Antigen (Active Infection)
Clinical Diagnostic Overview

Why Stool Antigen Testing is the Non-Invasive Gold Standard

Helicobacter pylori colonizes the gastric epithelial lining, inducing chronic gastritis, peptic ulcer disease, and increasing gastric adenocarcinoma risk. Direct stool antigen detection provides active infection confirmation without invasive endoscopy.

Direct Active Detection

Active vs. Historical Infection

Unlike serological antibody tests that remain positive for years following bacterial eradication, the QuRapid fecal antigen assay identifies only shedding, viable bacteria.

  • Eliminates false-positive past exposure readings
  • Recommended by Maastricht VI Consensus
  • Accurate test of cure 4–6 weeks post-therapy
Point-of-Care Workflow

Non-Invasive Patient Comfort

Avoids invasive gastroscopy, anesthesia risks, and expensive hospital endoscopy suites for routine dyspepsia workup and pediatric screening.

  • Screw-cap sampling stick minimizes stool handling
  • Homogenized pre-filled buffer extraction
  • Zero dietary restrictions or fasting required
Clinic Efficiency

Rapid 10-Minute Triage

Allows outpatient clinics and gastroenterology practices across the UAE to initiate first-line triple or quadruple eradication therapy on the same day.

  • Immediate visual results in 10 minutes
  • Reduces empirical PPI over-prescription
  • Same-day dispatch across Dubai & Abu Dhabi

Analytical & Clinical Validation Data

Multi-Center Clinical Evaluation vs. Endoscopic Biopsy
Diagnostic Parameter Clinical Performance Metric 95% Confidence Interval Reference Comparison
Diagnostic Sensitivity >95.0% 90.0% – 97.9% Endoscopic Biopsy (Histology / RUT)
Diagnostic Specificity >95.7% 92.3% – 97.9% Endoscopic Biopsy (Histology / RUT)
Overall Diagnostic Accuracy 98.6% 96.8% – 99.4% Total Concordance Rate
Limit of Detection (LoD) 50 ng/mL N/A H. pylori Bacterial Antigen
Interference Profile No Cross-Reactivity N/A E. coli, Campylobacter, Salmonella, Shigella
*Note: Patients taking proton pump inhibitors (PPIs) or bismuth compounds within 2 weeks, or antibiotics within 4 weeks of testing, may experience suppressed bacterial shedding. Temporary discontinuation is clinically advised where feasible.
Standard Operating Procedure

4-Step Rapid Diagnostic Protocol

Perform rapid fecal antigen testing with pre-dispensed extraction buffer tubes. No specialized laboratory centrifuge or equipment required.

1

Stool Sampling

Unscrew the collection tube cap. Insert the grooved applicator stick into the fecal specimen at 3 different sites to collect ~50 mg of feces (1/4 pea size). For watery diarrhea, aspirate 50 µL.

2

Buffer Mixing

Re-insert the applicator stick into the collection tube containing extraction buffer. Tighten cap firmly and shake vigorously for 15 seconds to ensure complete fecal dissolution.

3

Cassette Loading

Break off the dropper tip of the collection tube. Invert vertically and dispense exactly 2 drops (approx. 80 µL) of the sample extract into the sample well (S) of the test cassette.

4

10-Min Readout

Start timer. Read visual results at 10 minutes. Do not interpret after 15 minutes as late chromatographic background clearing may affect faint line verification.

Result Interpretation Guide

Clear Colorimetric Result Windows

Visual interpretation criteria for point-of-care clinicians and laboratory personnel.

Diagnostic Result Interpretation

Evaluate lines appearing in the Control (C) and Test (T) regions.

Positive (Active Infection)
Two distinct bands: Control line (C) and Test line (T). Indicates active H. pylori gastric colonization.
Negative (No Antigen Detected)
Single colored line at Control (C). No visible line at Test (T). Patient is uninfected or antigen is below LoD.
Invalid Test
No line at Control (C). Insufficient sample volume or procedural error. Retest with fresh cassette.

Recommended Clinical Pathways

Clinical decision support based on patient history and presentation.

Initial Dyspepsia Workup
Positive result warrants initiation of first-line eradication therapy (PPI + Clarithromycin + Amoxicillin/Metronidazole).
Post-Treatment Test of Cure
Perform 4 to 6 weeks post-antibiotic completion to verify complete eradication of gastric colonization.
Pediatric Evaluation
Non-invasive, painless diagnostic modality ideal for pediatric recurrent abdominal pain workup.
Packaging Configuration

Everything Required for 25 Determinations

Each box is sealed with professional point-of-care extraction components.

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25 Test Cassettes Individually sealed in foil pouches with desiccant
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25 Collection Tubes Pre-filled extraction buffer with integrated stool sampling sticks
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Instructions for Use Illustrated SOP protocol and interpretation guide
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Tube Workstation Pre-cut cardboard tube rack integrated into box packaging
Clinical Support

Frequently Asked Questions

Need validation dossiers, regulatory certificates, or bulk clinic pricing? Contact our clinical diagnostic specialists in Dubai.

Contact Clinical Specialist
Why is Stool Antigen preferred over Blood Antibody testing?

Antibody tests detect past exposure and remain positive for months or years after eradication. Stool antigen directly detects living, shedding bacteria, making it the non-invasive gold standard for active infection and post-treatment verification.

Should patients discontinue PPIs before testing?

Yes. Proton pump inhibitors (PPIs) and antibiotics should ideally be discontinued 2 weeks and 4 weeks prior to testing, respectively, to prevent false-negative results from bacterial suppression.

Does dietary intake affect the test results?

No. The monoclonal antibody immunoassay is completely unaffected by food, beverages, dietary fibers, or alcohol intake.

What is the turnaround time and reading window for the test?

Clear visual bands appear within 10 minutes. Results should not be interpreted beyond 15 minutes to prevent chromatographic background interference.

How can UAE medical centers procure this test?

QuRapid maintains extensive stock in Dubai, offering same-day delivery to local laboratories, gastroenterology clinics, and hospitals with complete regulatory documentation.

Equip Your Clinic With QuRapid H. Pylori Stool Antigen Rapid Tests

Order CE-IVD certified H. Pylori Antigen Rapid Test Kits with same-day dispatch across Dubai, Abu Dhabi, and the UAE. Wholesale volume pricing available for hospitals, gastroenterology clinics, and clinical laboratories.

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