Helicobacter Test INFAI® 

¹³C-Urea breath test for Helicobacter pylori infection



Unique features

  • Internationally approved
    Helicobacter Test INFAI® is registered in all countries of the European Union and subsequently accepted by many other countries.

  • Easy to use
    The simple and patient friendly test protocol ensures a high degree of reliability and compliance.

  • Non invasive
    ¹³C-urea is already present in the human body so there is no reason to expect any harmful side effects. The test can be used during pregnancy and lactation.

  • No contraindication
    No contraindications of the test are known.

  • Highly reliable post-eradication control
    The test kit is designed for use both before and after eradication treatment.

  • Sensitive and specific
    The efficacy of the test in detecting active Helicobacter pylori identifies it as the new gold standard.

  • Cost effective
    In many cases a breath test can demonstrate Helicobacter pylori infection without recourse to endoscopy.


Videos

The following video gives an overview of the Helicobacter Test INFAI®.


The following video shows the execution of the Helicobacter Test INFAI® in a clinical study in Nottingham.


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

 

PPI Patent

  • EP1685851, Method for the diagnosis of Helicobacter pylori infection and a diagnostic kit for performing the method, European Patent, 13.05.2009
  • US20030032081, Method for the diagnosis of Helicobacter pylori infection and a diagnostic kit for performing the method, US Patent, 13.02.2013

Heliblue Patent

  • EP1415159, Method and Diagnostic Kit for diagnosis of Helicobacter pylori, European Patent, 24.10.2007
  • US7033838, Method for the diagnosis of Helicobacter pylori infection and a diagnostic kit for performing the method, US Patent, 25.04.2006
  • WO2003014744, Method and Diagnostic Kit for diagnosis of Helicobacter pylori, International Patent, 22.02.2003



Helicobacter Test INFAI® CLINIPAC 50



Due to increasing demand, INFAI now supplies a large packaging size for clinical pharmacies and group practices.

  • Especially used for GPs, laboratory and hospitals
  • Cost-effective, cost savings of 40-53 % in comparison to the single test
  • Contains test material for diagnosis of 50 patients
  • Safe and reliable

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

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)
Production

 

References

  • World Health Organization WHO (1994): Classification of Helicobacter pylori as a category 1 carcinogen. (Lancet 344)
  • Current European concepts in the management of Helicobacter pylori infection:The Maastricht Consensus Report. (Gut 1997; 41: 8-13)
  • Current concepts in the management of Helicobacter pylori infection - The Maastricht 2-2000 Consensus Report.(Aliment Pharmacol Ther 2002; 16: 167-180)
  • Current concepts in the management of Helicobacter pylori infection: The Maastricht III Consensus Report (Gut 2007; 56: 772-781).
  • Management of Helicobacter pylori infection - The Maastricht IV / Florence Consensus Report (Gut 2012; 61: 646-664)
  • Significant decrease in prevalence of H. pylori in the Czech Republic.
    Bureš et al.; WJG, 2012, 18(32): 4412.
  • Comparison of non-invasive tests to detect Helicobacter pylori infection in children and adolescents: Results of a multicenter European study.
    Mégraud, F. et al.; The Journal of Pediatrics, 2005, 146(2): 198.
  • Albarti, A. (2002): Utility and acceptability of INFAI C-13-urea breath test. BMS 324: 485.
  • (2001): INFAI breath test in general practice. Cleveland Med. J. 4: 116-8.
  • Labenz J., Aygen S., Hennemann 0., Peitz U., Tillenburg B., Börsch G., Stolte M. (1995): Validity of a novel biopsy urease test (HUT) and a simplified ¹³C-urea breath test for diagnosis of Helicobacter pylori infection and estimation of the severity of gastritis.    Digestion 57(6): 391-7.
  • Labenz J., Stolte M., Aygen S., Hennemann O., Bertrams O., Börsch G. (1993): Qualitative und semiquantitative invasive und nicht-invasive Diagnostik der Helicobacter pylori-Kolonisation der gastralen Mukosa. Z Gastroenterol 31(7-8): 437-43.