Helicobacter Test INFAI^®

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Helicobacter Test INFAI

¹³C-Urea breath test for detection of Helicobacter pylori

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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.

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.

	Helicobacter pylori infections leads to		gastritis leads to
	100 % detectable gastritis		30 - 40 % dyspeptic complaints
			10 - 15 % duodenal and peptic ulcer	carcinoma

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.

Helicobacter Test INFAI^® designed for reflux patients

INFAI has developed a new breath test on the basis of the well known Helicobacter Test INFAI^® designed specifically for reflux patients receiving PPI medication.

50% of all dyspeptic patients are permanently on proton pump inhibitors (PPI). Intake of PPI causes a significant decrease on the sensitivity of non-invasive methods for diagnosis of Helicobacter pylori infection, such as ¹³C-urea breath test and stool test. Detection of Helicobacter pylori in reflux patients therefore required a withdrawal of PPIs for 14 days.

A new formulation of Helicobacter Test INFAI^® now overcomes this inconvenience and offers the following advantages for reflux patients:

• No withdrawal of PPI medication necessary
  
• Simple performance as before
  
• Safe and reliable diagnosis of Helicobacter pylori infection
  

For more information please contact INFAI. There is also a flyer available for printing.

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.	Approved since
Helicobacter Test INFAI®	75 mg 13C-Urea	mass spectrometry	EU/1/97/045/001	1997/08/14
Helicobacter Test INFAI®	75 mg 13C-Urea	infrared spectroscopy	EU/1/97/045/002	2002/05/02
Helicobacter Test INFAI® for children age 3-11	45 mg 13C-Urea	mass spectrometry	EU/1/97/045/003	2002/10/10
Helicobacter Test INFAI® CLINIPAC 50	75 mg 13C-Urea	infrared spectroscopy	EU/1/97/045/004	2004/02/27

References

• World Health Organisation 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 (1997): Recommendation of ¹³C-urea breath test in the management of dyspeptic patients under 45 years. Gut 41: 8-13.
  
• Current European concepts in the management of Helicobacter pylori infection. (2000): Guidelines for the Management of Helicobacter Infection in Primary Care. The Maastrich 2-2000 Consensus Report 21-2.
  
• ¹³C-urea breath test is the gold standard test for diagnosis of Helicobacter pylori infection and for the confirmation of eradication.
  National Institut of Health Consensus Conference. (1994): Helicobacter pylori in peptic ulcer disease. JAMA 272: 65-9. (From European Society for Primary Care Gastroenterology; The Management of H. pylori September 1999).
  

Publications

• Mégraud, F.; Amarri, S.; Ashorn, M.; Bodanszky, H.; Cabral, J.; Casswall, T.; Celinska-Cedro, D.; Glupczynski, Y.; Gottrand, F.; Kalach, N.; Keller, KM.; Koletzko, S.; Martinez-Gomez, M.; O'Morain, C.; Pehlivanoglu, E.; Roma-Giannikou, E.; Sedlackova, M.; Urruzuno, P.; Wewer, V. (2005): Comparison of non-invasive tests to detect Helicobacter pylori infection in children and adolescents: Results of a multicenter European study. The Journal of Pediatrics 146(2): 198-203. Digital Object Identifier
  
• Albarti, A. (2002): Utility and acceptability of INFAI C-13-urea breath test. BMS 324: 485.
  
• Mégraud, F. (2002): Non-invasive diagnostic test for Helicobacter pylori in children. Evaluation in a multicentric European study. Gastrointestinal Pathology and Helicobacter 14(01).
  
• (2001): INFAI breath test in general practice. Cleveland Med. J. 4: 116-8.
  
• (2000): The Maastrich 2-2000 Consensus Report
  Current Concepts in the Management of Helicobacter pylori Infection.
  
• 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. PUBMED
  
• Adamek R.J., Freitag Al., Labenz J, Rühl G.H., Aygen S., Hennemann 0., Wegener M. (1994): Modifizierter ¹³C-Harnstoff-Atemtest in der Helicobacter-pylori-Besiedlung der gastralen Mucosa. Dtsch. med. Wschr. 119: 1569-157.
  
• Adamek R.J., Freitag M, Opferkuch W., Rühl G.H., Wegener M. (1994): Intravenous Omeprazole/Amoxillin and Omeprazole Pretreatment in Helicobacter pylori-Positive Acute Peptic Ulcer Bleeding. Scand. J Gastroenterol. 29(10): 880-883.
  
• Labenz J, Börsch G. (1994): Klinik und Diagnostik der Helicobacter-pylori-Infektion. Dtsch. med. Wschr. 119: 633-636.
  
• Labenz J., Stolte M., Aygen S., Hennemann 0., Bertrams 0., 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. PUBMED
  

More information

More information can be found in the Full Prescribing Information for Helicobacter Test INFAI^®.
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Patient information

Product information

Production

Helicobacter Test INFAI^® can be ordered from a number of distributors.