What is Helicobacter Test INFAI?
Helicobacter Test INFAI is a diagnostic test. It comes in a bottle in the form of a powder to be made up into a drinking solution.
The powder is the active ingredient 13C urea (45 mg for children and adolescents or 75 mg for adults).
What is Helicobacter Test INFAI used for?
Helicobacter Test INFAI is used for the diagnosis of infection with Helicobacter pylori in the stomach and duodenum (the first section of the small intestine). H. pylori is a bacterium that contributes to the onset of diseases such as dyspepsia (gastric acidity, abdominal bloating and nausea), gastritis (stomach inflammation) and peptic ulcer (ulcerative lesions of the stomach or duodenum). Helicobacter Test INFAI is used in diagnosis of infection in adults, adolescents with peptic ulcer predisposition and in children from 3 to 11 years of age. In children it can only be used if invasive techniques cannot be used (for example, taking a sample from the stomach using a probe) or in the presence of discordant results deriving from invasive analyzes, or to evaluate the efficacy of the elimination therapy of H. pylori. The medicine can only be obtained with a prescription.
How is Helicobacter Test INFAI used?
Helicobacter Test INFAI is a
: that is, breath samples are collected and sent to a specialized laboratory for analysis.
To perform the test the patient must collect four breath samples, two before taking Helicobacter Test INFAI and two after. The patient must have been fasting for at least 6 hours, preferably overnight. First, the patient collects two samples of exhaled air using the container or bag supplied with Helicobacter Test INFAI. The patient then consumes the "test meal" (200 ml of undiluted orange juice or 1 g of citric acid dissolved in 200 ml of water ), then ingests the Helicobacter Test INFAI solution dissolved in water. Finally, 30 minutes after administration of the solution, the patient collects two more breath samples. In children aged 3-11 the "test meal" consists of 100 ml of undiluted orange juice. For more information on performing the test, see the package leaflet.
How does Helicobacter Test INFAI work?
The active ingredient in Helicobacter Test INFAI, 13C urea, is the natural chemical urea marked with carbon 13 (13C). This means that it contains 13C, a rare form of the carbon atom, instead of
carbon 12 (12C), the most widespread form in nature.
H. pylori it contains enzymes, called urease, which make it able to break down urea into carbon dioxide, which is eliminated with exhalation. When the patient takes Helicobacter Test INFAI, the 13C urea contained in the solution is transformed by H. pylori in carbon dioxide, which also contains "13C. This marked carbon dioxide can be measured by specialized laboratories using a technique called" mass spectrometry. "If after 30 minutes the exhaled air sample contains marked carbon dioxide (positive test), this means that there is an "infection with H.pylori. If the exhaled air is free of marked carbon dioxide, this means that there are no bacteria in the stomach or duodenum.
How has Helicobacter Test INFAI been studied?
Helicobacter Test INFAI was examined in four studies involving a total of 561 adult patients and in one study involving 335 children and adolescents. All of these subjects took 75 mg of 13C urea, except for 204 children under the age of 11. years, in which the dose was 45 mg. One of the adult studies was done with subjects who had undergone antibiotic treatment to heal the infection. In all studies, patients underwent endoscopy and histological examination (removal of a fragment of tissue from the stomach and subsequent microscopic analysis) as well as the breath test with Helicobacter Test INFAI, in order to compare the results of the two diagnostic tests.
What benefit has Helicobacter Test INFAI shown during the studies?
In all studies the results of the examination carried out with Helicobacter Test INFAI agreed with the results obtained with endoscopy and histological examination in more than 95% of cases.
What is the risk associated with Helicobacter Test INFAI?
There are no known side effects. However, if the patient vomits during the test and requires repetition, it cannot be performed until the following day.
Helicobacter Test INFAI should not be performed on patients with a known or suspected gastric infection or atrophic gastritis (inflammation of the stomach which destroys the lining of the stomach), which could interfere with the breathing test.
Why has Helicobacter Test INFAI been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Helicobacter Test INFAI's benefits are greater than its risks for use in diagnosis. in vivo of gastroduodenal infection by H. pylori in adults and adolescents with peptic ulcer predisposition, as well as in children aged 3 to 11 years to evaluate the efficacy of eradication therapy or when invasive techniques cannot be used or in the presence of discordant results deriving from invasive analyzes and therefore recommended the issue of the "authorization to market the product".
Other information about Helicobacter Test INFAI:
On 14 August 1997, the European Commission granted INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH a "marketing authorization" for Helicobacter Test INFAI, valid throughout the European Union. The "marketing authorization" it was renewed on August 14, 2002 and August 14, 2007.
For the complete version of the Helicobacter Test INFAI EPAR click here.
Last update of this summary: 09-2007.
The information on Helicobacter Test INFAI published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
