Europe — EMA
Helicobacter Test (13c-Urea)
Helicobacter Test is a 13C‑Urea breath test kit for detecting Helicobacter pylori infection, offering a non‑invasive, EU‑compliant diagnostic solution.
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What is 13c-Urea?
The Helicobacter Test is a diagnostic kit containing the active ingredient 13C‑Urea, supplied as a kit for oral administration. It is used to detect Helicobacter pylori infection by measuring 13CO2 in exhaled breath after urea hydrolysis. It is intended for use in clinics and hospitals, providing a non‑invasive method for confirming infection status.
What is 13c-Urea used for?
The Helicobacter Test is employed primarily for the detection of Helicobacter pylori infection, a common cause of gastritis, peptic ulcer disease, and gastric cancer risk.
- Screening patients with dyspeptic symptoms for H. pylori infection. - Confirming eradication after antibiotic therapy. - Assessing infection status before initiating long‑term proton pump inhibitor therapy. - Supporting epidemiological studies of H. pylori prevalence. - Guiding clinical decision‑making in gastroenterology practice.
What are the side effects of 13c-Urea?
Adverse reactions to the Helicobacter Test are generally uncommon and usually mild, reflecting the non‑invasive nature of the breath test.
Common: - Mild nausea or stomach upset. - Temporary metallic taste. - Slight headache. - Minor abdominal bloating.
Serious: - Allergic reaction such as rash, itching, or swelling. - Anaphylaxis (extremely rare). - Severe respiratory difficulty. - Persistent vomiting.
What precautions apply to 13c-Urea?
Precautions should be observed to ensure accurate results and patient safety.
- Patients should fast for at least 2 hours before the test. - Recent antibiotic or proton pump inhibitor use may affect results; discuss with clinician. - Pregnancy and lactation status should be disclosed. - Patients with known urea allergy should avoid the test. - Ensure proper collection of breath samples to avoid contamination. - Avoid smoking or chewing gum immediately before sample collection.
What does 13c-Urea interact with?
Certain medications and substances can interfere with the accuracy of the Helicobacter Test.
Avoid: - Recent use of antibiotics (e.g., clarithromycin, amoxicillin) within 4 weeks. - Use of proton pump inhibitors or H2 blockers within 2 weeks. - Bismuth compounds within 2 weeks.
Use with caution: - Consumption of carbonated beverages or smoking within 30 minutes of the test. - High‑carbohydrate meals before the fasting period. - Severe lung disease may affect breath sample quality.
