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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, designed for oral administration to detect Helicobacter pylori infection. It is marketed in the European Union and supplied as a single‑use breath test kit. The test utilizes a non‑radioactive isotope to assess urease activity associated with H. pylori, providing a non‑invasive diagnostic option. The kit includes calibrated substrates, collection devices, and detailed instructions for clinical or laboratory use.

Manufacturer / TM Owner

Infai Gmbh

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Indications & Clinical Uses

The 13C‑Urea Breath Test is employed primarily to identify active infection with Helicobacter pylori, a bacterium linked to 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 treatment.
  • Supporting epidemiological studies of H. pylori prevalence.
  • Guiding clinical decisions in patients with a history of gastric ulcer or MALT lymphoma.

Side Effects

The 13C‑Urea Breath Test is generally well tolerated, but some individuals may experience mild or, rarely, more serious reactions.

Common

  • Transient metallic or bitter taste in the mouth.
  • Mild nausea or stomach discomfort.
  • Increased belching or flatulence after ingestion of the test substrate.

Serious

  • Allergic reaction such as rash, itching, or swelling.
  • Severe abdominal pain or cramping.
  • Respiratory difficulty or wheezing indicative of an anaphylactic response.

Precautions & Warnings

When using the 13C‑Urea Breath Test, certain precautions should be observed to ensure accurate results and patient safety.

  • Patients should fast for at least 2 hours before the test unless instructed otherwise.
  • Recent use of antibiotics, bismuth compounds, or proton pump inhibitors may affect test accuracy; a washout period is often recommended.
  • Individuals with known urea metabolism disorders should discuss the test with a healthcare professional.
  • Pregnant or lactating women should be evaluated for potential risks before testing.
  • Ensure proper collection and handling of breath samples to avoid contamination.

Avoid Interactions

The test substrate can interact with certain medications or substances, potentially influencing the result or causing adverse effects.

Avoid

  • Antibiotics (e.g., clarithromycin, amoxicillin) taken within 2–4 weeks prior to testing.
  • Proton pump inhibitors or H2‑receptor antagonists used within 1–2 weeks before the test.
  • Bismuth‑containing compounds (e.g., Pepto‑Bismol) within the preceding week.

Use with caution

  • Recent use of non‑steroidal anti‑inflammatory drugs (NSAIDs) that may cause gastric irritation.
  • Herbal supplements affecting gastric pH, such as antacids or proton‑pump‑inhibiting herbs.
  • Patients with severe renal or hepatic impairment should be monitored.

Frequently Asked Questions

The test measures the amount of 13C‑labeled carbon dioxide in the breath after ingestion of 13C‑Urea; H. pylori urease breaks down the urea, releasing labeled CO2 that is exhaled and quantified.

After a fasting period, the patient ingests a capsule containing 13C‑Urea. Breath samples are collected before and about 30 minutes after ingestion, then analyzed for 13C‑CO2 enrichment.

Patients who have taken antibiotics, proton pump inhibitors, H2‑blockers, or bismuth compounds within the recommended washout periods, as well as those with known urea metabolism disorders, should avoid or postpone the test.

Laboratory analysis typically provides results within a few hours to one business day after the breath samples are received.

Yes, recent antibiotic therapy can suppress H. pylori activity, leading to false‑negative results; a washout period of at least two weeks is commonly advised.

Most individuals experience no symptoms; occasional mild nausea, a metallic taste, or increased belching may occur.

The test uses a non‑radioactive isotope and is generally considered low risk, but pregnant or lactating women should discuss potential benefits and risks with their healthcare provider.

Patients are usually instructed to fast for at least 2 hours, avoid smoking, and discontinue antibiotics, PPIs, H2‑blockers, and bismuth products for the recommended washout periods before testing.

A positive result indicates active urease activity consistent with current Helicobacter pylori infection in the stomach.

A repeat breath test performed 4–6 weeks after completing eradication therapy can confirm whether the infection has been successfully cleared.

Patients should avoid foods that may affect gastric pH, such as high‑fat meals, and follow any specific dietary instructions provided by the testing facility.

Breath collection devices are sealed immediately after sampling, stored at recommended temperatures, and transported to the laboratory promptly to prevent CO2 loss or contamination.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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