GNH USA

Europe — EMA

Helicobacter Test

Helicobacter Test is a 13C‑Urea breath test kit for detecting Helicobacter pylori infection, offering a non‑invasive, EU‑compliant diagnostic solution.

13c-Urea

Request sourcing

1
Pack/s

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.

Frequently asked questions

What is the principle behind the Helicobacter Test?+
The test uses 13C‑Urea, which is hydrolyzed by H. pylori urease in the stomach, releasing 13CO2 that is measured in the patient’s exhaled breath.
How is the Helicobacter Test performed?+
The patient ingests a solution containing 13C‑Urea, then breath samples are collected before and after a set interval to measure the ratio of 13CO2 to 12CO2.
Who should consider taking the Helicobacter Test?+
Individuals with persistent dyspepsia, a history of peptic ulcer disease, or those undergoing evaluation for H. pylori‑related conditions may be candidates.
Can the Helicobacter Test be used to confirm eradication after treatment?+
Yes, a repeat breath test performed several weeks after completing therapy can help determine whether H. pylori has been successfully eradicated.
What preparations are required before the test?+
Patients are typically advised to fast for at least two hours, avoid antibiotics, proton pump inhibitors, and bismuth compounds for a specified period, and refrain from smoking or chewing gum before sample collection.
Is the Helicobacter Test safe for pregnant or breastfeeding women?+
Safety data are limited; clinicians should evaluate the risk‑benefit ratio and discuss any concerns with the patient before proceeding.
What are common side effects of the test?+
Most people experience none, but mild nausea, a temporary metallic taste, slight headache, or minor abdominal bloating can occur.
What rare serious reactions have been reported?+
Rarely, allergic reactions such as rash, itching, swelling, or anaphylaxis may occur, requiring immediate medical attention.
How accurate is the 13C‑Urea breath test compared with other H. pylori detection methods?+
The 13C‑Urea breath test is considered highly sensitive and specific, comparable to endoscopic biopsy and stool antigen tests when proper preparation is followed.
Can certain foods affect the results of the Helicobacter Test?+
Yes, recent consumption of carbonated drinks, smoking, or chewing gum can alter breath CO2 levels and may lead to inaccurate results.
Is the Helicobacter Test regulated in the European Union?+
The test complies with EU regulations for in‑vitro diagnostic devices and is marketed as an EU‑certified diagnostic kit.
What should be done if a patient has a known urea allergy?+
Patients with a documented urea allergy should not undergo the test; alternative diagnostic methods such as stool antigen testing or endoscopic biopsy should be considered.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
13c-Urea
Route
Oral Use
Manufacturer
Infai Gmbh
Origin
EU

Related products