Europe — EMA
Helicobacter Test For Children Of The Age 3-11
Helicobacter Test for Children aged 3‑11 uses 13C‑Urea breath analysis to diagnose H. pylori infection safely and non‑invasively.
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What is 13c-Urea?
The Helicobacter Test for Children of the Age 3‑11, formulated with the isotopic marker 13C‑Urea, is an oral diagnostic assay designed to detect Helicobacter pylori infection in pediatric patients. Produced for European market, the test utilizes a breath‑test principle and is intended for use with supervision. It does not contain therapeutic medication and is approved for clinical use in children aged three to eleven years.
What is 13c-Urea used for?
Helicobacter Test for Children aged 3‑11 is used as a diagnostic tool to identify active Helicobacter pylori infection in pediatric patients.
- Detects H. pylori infection via 13C‑urea breath test in children 3–11 years old. - Supports clinical decision‑making for treatment initiation. - Provides a non‑invasive alternative to endoscopic sampling. - Can be used to confirm eradication after therapy. - Suitable for screening in epidemiological studies involving school‑aged children.
What are the side effects of 13c-Urea?
The test may be associated with transient, generally mild reactions related to the test procedure or the urea substrate.
Common: - Temporary metallic taste in the mouth. - Mild nausea or stomach discomfort. - Brief headache or dizziness. - Slight increase in breath odor due to labeled carbon dioxide.
Serious: - Allergic reaction such as rash, itching, or swelling. - Severe respiratory distress or anaphylaxis (very rare). - Persistent vomiting or abdominal pain requiring medical attention.
What precautions apply to 13c-Urea?
When using the Helicobacter Test for Children, certain precautions should be observed to ensure accurate results and patient safety.
- Verify the child is between 3 and 11 years of age before testing. - Ensure the child has fasted according to the test protocol (usually 2‑4 hours). - Review medical history for known urea allergy or severe metabolic disorders. - Inform the clinician of any recent antibiotic, proton‑pump inhibitor, or bismuth use, as these may affect results. - Use the test only under qualified healthcare supervision. - Store the kit at room temperature, protected from moisture.
What does 13c-Urea interact with?
Certain medications or substances can interfere with the accuracy of the 13C‑urea breath test or increase the risk of adverse reactions.
Avoid: - Recent use (within 2 weeks) of antibiotics active against H. pylori. - Proton‑pump inhibitors or H2‑receptor antagonists taken within 2 weeks. - Bismuth‑containing compounds within 4 weeks. - High‑dose vitamin C supplements taken on the day of testing (may affect breath results). Use with caution: - Antacids taken on the day of testing (may modestly alter gastric pH). - Herbal remedies that affect gastric acidity, such as licorice root.
Frequently asked questions
What is the principle behind the Helicobacter Test for children aged 3‑11?+
How is the 13C‑Urea administered in the pediatric test?+
What preparation is required before the test?+
How long does it take to obtain results after the breath sample is collected?+
Can the test be used to confirm eradication after treatment?+
Is the test safe for children with asthma or other respiratory conditions?+
What are the most common side effects observed in children undergoing the test?+
How does recent antibiotic use affect the test outcome?+
Where can the Helicobacter Test for children be obtained in the EU?+
Does the test require a prescription or medical order?+
How is the breath sample collected from a child?+
What is the accuracy of the 13C‑Urea breath test in children?+
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