Unique features
Videos
The following video gives an overview over the new state-of-the-art production line in Hagen as well as the performance of the 13C-Urea breath test and the analysis on the basis of different methods.
The following video shows the execution of the Helicobacter Test INFAI® in a clinical study in Nottingham (Title: Helicobacter eradication to prevent ulcer bleeding in aspirin users: a large simple randomised controlled trial. Sponsor: University of Nottingham, EudraCT Number: 2011-003425-96).
The most used ¹³C-urea breath test world-wide
Helicobacter Test INFAI® is a breath test for direct, non-invasive detection of the bacterium Helicobacter pylori. The test is a registered medicinal product and was approved by the European Commission in 1997 for all 15 member states and subsequently accepted by many other countries outside the European Union. Helicobacter Test INFAI® has now become a standard diagnostic tool and is the most used ¹³C-urea breath test world-wide. The test kit is designed for convenient use in hospitals and by general practitioners. Breath samples can be analysed in a suitably equipped hospital laboratory or can be mailed to any qualified laboratory.
More information can be found in the Helicobacter Test INFAI® Brochure.
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Clinical Indications for Helicobacter Test INFAI® Helicobacter Test INFAI® detects infection of the stomach by the bacterium Helicobacter pylori, the primary causative agent in most cases of peptic ulcer disease. The ¹³C-urea breath test is non-invasive and non-radioactive and has been recommended by the leading societies of gastroenterology (European Society for Primary Care Gastroenterology; European Helicobacter pylori Study Group) for use both before and after eradication treatment.
Quality criteria of Helicobacter Test INFAI®
The specificity (98,5%) and sensitivity (97,9%) of Helicobacter Test INFAI® are equal to traditional invasive, direct diagnostic methods (endoscopy and biopsy). Because the breath test result reflects current Helicobacter pylori infection status it can be used to confirm successful eradication therapy four weeks after the completion of treatment.
Comparison to other tests
Some companies use a cut-off point of 1.5‰ and a sampling time of 10 minutes with a reduced dose (50 mg) of ¹³C-urea for detection of Helicobacter pylori.
This test design is not sufficient to get correct results; the short sampling time and lower cutoff point can cause false negative results. This is because maximum urease activity takes place between 20 and 30 minutes, especially after eradication therapy when H. pylori colonization rate is reduced.
INFAI UK therefore uses a cut-off point of 4‰ and a sampling time of 30 minutes in order to achieve maximum sensitivity and specificity. This corresponds with the values most used in the literature (cutoff point of 3‰-5‰, with a sampling time of 30 minutes using 75-100 mg of ¹³C-urea).
Ongoing studies for Helicobacter Test INFAI®
Study: PPI; Eudra CT Number: 2008-008010-39
The Sensitivity and Specificity in Helicobacter Pylori Positive and Negative Patients with Dypepsia Taking Proton Pump Inhibitors. Sponsor: INFAI
Study: Aptalis; Eudra CT Number: 2010-019064-36
Efficacy and Safety of PYLERA (Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Hydrochloride) With Omeprazole Given x 10 Days in Subjects Who Failed Treatment for Eradication of Helicobacter pylori. Sponsor: Aptalis
Study: HEAT; Eudra CT Number: 2011-003425-96
Helicobacter eradiation to prevent ulcer bleeding in aspirin users: a large simple randomised controlled trial (HEAT). Sponsor: University of Nottingham
Dumbleton J.S., et al. (2015): The Helicobacter Eradication Aspirin Trial (HEAT):
A Large Simple Randomised Controlled Trial Using Novel Methodology in Primary Care. EBioMedicine 2: 1200–1204
Helicobacter Test INFAI® CLINIPAC 50
Due to increasing demand, INFAI now supplies a large packaging size for clinical pharmacies and group practices.
More information can be found in the Clinipac Brochure.
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Drug formulation for the Helicobacter Test INFAI®
The following drug formulations of the Helicobacter Test INFAI® are available in the European Union and in many other countries worldwide:
| Name | Active | Ingredient | Analytics | EU-No. | ||||
| Helicobacter Test INFAI® | 75 mg | ¹³C-Urea | mass spectrometry | EU/1/97/045/001 | ||||
| Helicobacter Test INFAI® | 75 mg | ¹³C-Urea | infrared spectroscopy | EU/1/97/045/002 | ||||
| Helicobacter Test INFAI® for children age 3-11 |
45 mg | ¹³C-Urea | mass spectrometry | EU/1/97/045/003 | ||||
| Helicobacter Test INFAI® CLINIPAC 50 |
75 mg | ¹³C-Urea | infrared spectroscopy | EU/1/97/045/004 | ||||
| Helicobacter Test INFAI® CLINIPAC BASIC |
75 mg | ¹³C-Urea | infrared spectroscopy or mass spectrometry |
EU/1/97/045/005 |
More information about Helicobacter Test INFAI® can be found at the EUROPEAN MEDICINES AGENCY (EMA).
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Patient information
Product information: (Recent versions at EMA in various languages)
Helicobacter Test INFAI® can be ordered from a number of distributors.
