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Helicobacter Test

Active Ingredient:
13c-Urea
Origin:
EU

Helicobacter Test (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.

Manufacturer / TM Owner

Infai Gmbh

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Indications & Clinical Uses

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.

Side Effects

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.

Precautions & Warnings

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.

Avoid Interactions

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

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.

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.

Individuals with persistent dyspepsia, a history of peptic ulcer disease, or those undergoing evaluation for H. pylori‑related conditions may be candidates.

Yes, a repeat breath test performed several weeks after completing therapy can help determine whether H. pylori has been successfully eradicated.

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.

Safety data are limited; clinicians should evaluate the risk‑benefit ratio and discuss any concerns with the patient before proceeding.

Most people experience none, but mild nausea, a temporary metallic taste, slight headache, or minor abdominal bloating can occur.

Rarely, allergic reactions such as rash, itching, swelling, or anaphylaxis may occur, requiring immediate medical attention.

The 13C‑Urea breath test is considered highly sensitive and specific, comparable to endoscopic biopsy and stool antigen tests when proper preparation is followed.

Yes, recent consumption of carbonated drinks, smoking, or chewing gum can alter breath CO2 levels and may lead to inaccurate results.

The test complies with EU regulations for in‑vitro diagnostic devices and is marketed as an EU‑certified diagnostic kit.

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.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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