Amended Helicobacter pylori 13-C breath test

Helicobacter pylori 13-C breath test – a non-invasive method for diagnostics and therapy monitoring
Previous diagnostic techniques were limited to indirectly detecting antibodies against Helicobacter pylori, detecting Helicobacter pylori in the stool along with evidence from biopsy material.
The frequently used screening method using the EIA (enzyme immunoassay) to provide evidence of antibodies against Helicobacter pylori has the disadvantage of not being able to detect very recent infections due to the fact that no antibodies have been produced yet. It is also unsuitable for eradication monitoring, since the antibodies may persist for a very long time.

The disadvantage of detecting Helicobacter pylori in the stool is that, depending on the stool consistency, different antigen quantities are excreted with the stool. In addition, the Helicobacter pylori stool test is also problematic in therapy monitoring. Invasive endoscopic sampling is unpleasant for patients, involves a risk of bleeding and is also an uncertain basis for diagnostics, since Helicobacter does not populate the gastric mucosa evenly. In order to ascertain the findings, biopsy samples need to be taken taken from different points of the gastric mucosa.

With the aid of the 13-C urea breath test, it is now possible to carry out simple, safe and non-invasive primary diagnostics and therapy monitoring. The sampled 13-C urea is split by the bacterial urease into 13-C carbon dioxide and ammonia. The 13-C isotope does not emit radiation and is completely harmless. The test can also be performed safely on pregnant women.

Test procedure

  1. Submission of a breathing sample in one breath bag (= zero sample).
  2. The patient swallows the 50 mg of 13-C urea (Diabact Urea Breath Test tablet) with 50-100 ml of water and without chewing it.
  3. A second breath sample is taken after 10 minutes.

Reference range
Results: The analysis is performed using isotopic spectrometry (content: 13-C carbon dioxide).
A relative increase of 13-C carbon dioxide after 10 minutes over the limit values (1.7 %) is regarded as a positive result.

Negative: < 1.3 %
Borderline: 1.3-1.7 %
Positive: > 1.7 %

Therapy should be monitored after 4-6 weeks. Patients should not take antibiotics or bismuth components 28 days before the test, nor proton pump inhibitors 14 days before the test.


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