Urea Breath Test
Headway Pylori UBT Kit
Urea [¹³C] Capsule Breath Test Kit
Reagent kit for urea breath test — the gold standard for non-invasive diagnosis of Helicobacter pylori infection.
HK Registration No. HK-63335
Overview
Product Overview
The Headway Pylori UBT kit is a reagent kit for the urea breath test, used for the in-vitro diagnosis of Helicobacter pylori infection. Each capsule contains 75 mg urea [¹³C]. Applicable for all ages and types of subjects, including pregnant women and young children.
Features & Advantages
Clinical Performance
- Gold standard for detecting active H. pylori infection
- Tests the entire gastric mucosa — not limited to biopsy sites
- Suitable for diagnosis and post-treatment monitoring
- Sensitivity 95% and specificity 95%-100% aligned with international UBT practice
Safety & Suitability
- Non-invasive, safe, and well-tolerated by all age groups
- Applicable for pregnant women and young children
- No observed adverse reactions in routine clinical use
- Urea dose is a small fraction of daily physiological urea production
Regulatory & Distribution
- Hong Kong Registration No.: HK-63335 under PHARMACY & POISONS BOARD OF HONG KONG
- Certificate Holder by MTI Millennium Co., Limited
- Sole HEADWAY urea breath test distributor for the region
Package Contents
- One Urea [¹³C] capsule (75 mg)
- Two breath bags
- One copy of Package Insert
Test Procedure
- 1Conduct on an empty stomach or at least two hours after eating.
- 2Blow into the baseline bag, then screw on the cap immediately.
- 3Take one Urea [¹³C] Capsule with 80–100 ml of water, then sit calmly for 30 minutes.
- 4Blow into the sample bag using the same technique.
- 5Test both bags with a Breath Test Analyzer and interpret DOB results.
Watch the Procedure
Watch on YouTubeClinical Applications
H. pylori is a Gram-negative micro-aerophilic bacterium and a Class I carcinogen of gastric cancer according to the WHO. More than 50% of the world's population harbours H. pylori in their upper GI tract.
The urea breath test detects active infections, supports post-treatment monitoring, and provides a comprehensive assessment of the entire gastric mucosa — without the discomfort or risks associated with endoscopy or tissue biopsy.
Patients should avoid antibiotics, bismuth preparations, and proton pump inhibitors within one month before testing, as these may cause false-negative results.
Bring "GOLD-STANDARD" UBT diagnostics to your practice
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