Helicobacter Test INFAI^®

¹³C-Urea breath test for detection of Helicobacter pylori

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Unique feutures

	International 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	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 effectiv	In many cases a breath test can demonstrate Helicobacter pylori infection with 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.

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Helicobacter Test INFAI^®.
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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 pylory infections leads to		gastritis leads to
	100 % detectable gastritis		30 - 40 % dyspeptic complaints
			10 - 15 % duodenal and peptic ulcer	carcinoma

Helicobacter Test INFAI ^® CLINIPAC 50

Due to the increasing demand, INFAI supplies from now on 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

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Clinipac.pdf.
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Helicobacter Test INFAI ^® designed for reflux patients

INFAI has 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

Drug formulation for the Helicobacter Test INFAI ^®

The following drug formulations of the Helicobacter Test INFAI ^® are available in the Europaen 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	14. 08. 1997
Helicobacter Test INFAI ®	75 mg 13C-Urea	infra-red spectroscopy	EU/1/97/045/002	02. 05. 2002
Helicobacter Test INFAI ® for children of the age 3-11	45 mg 13C-Urea	mass spectrometry	EU/1/97/045/003	10. 10. 2002
Helicobacter Test INFAI ® CLINIPAC 50	75 mg 13C-Urea	infra-red spectrometry	EU/1/97/045/004	27. 02. 2004

References

Classification of Helicobacter pylori as a category 1 carcinogen.
(World Health Organisation WHO; Lancet 344 1994)

Recommendation of ¹³C-urea breath test in the management of dyspeptic patients under 45 years.
(Curent European concepts in the management of Helicobacter pylori infection. The Maastrich Consensus Report. Gut 1997; 41: 8-13)

Guidelines for the Management of Helicobacter Infection in Primary Care
(Curent European concepts in the management of Helicobacter pylori infection. The Maastrich 2-2000 Consensus Report, 21-2 September 2000)

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. Helicobacter pylori in peptic ulcer disease. JAMA 1994; 272: 65-9)
(From European Society for Primary Care Gastroenterology; ´The Management of H pylori September 1999).

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.

Publications

1. Utility and acceptability of INFAI C-13-urea breath test
   A. Albarti; BMS 2002, 324, 485

2. INFAI breath test in general practice
   Cleveland Med. J. 2001; 4:116-8

3. Current Concepts in the Management of Helicobacter pylori Infection
   The The Maastrich 2-2000 Consensus Report

4. Non-invasive diagnostic test for Helicobacter pylori in children. Evaluation in a multicentric European study
   Mégraud; Gastrointestinal Pathology and Helicobacter 2002, 14.01

5. Qualitative und semiquantitative invasive und nicht-invasive Diagnostik der Helicobacter pyloriKolonisation der gastralen Mukosa
   Labenz J., Stolte M., Aygen S., Hennemann 0., Bertrams 0., Börsch G.; Z Gastroenterol 1993: 31: 43 7443

6. Klinik und Diagnostik der Helicobacter-pylori-Infektion
   Labenz J, Börsch G.; Dtsch. med. Wschr. 1 1 9 (1994) 633-636

7. Intravenous Omeprazole/Amoxillin and Omeprazole Pretreatment in Helicobacter pylori-Positive Acute Peptic Ulcer Bleeding
   Adamek R.J., Freitag M, Opferkuch W., Rühl G.H., Wegener M.; Scand. J Gastroenterol.; 29, 10, 1994, 880-883

8. Modifizierter 13C-Harnstoff-Atemtest in der Helicobacter-pylori-Besiedlung der gastralen Mucosa
   Adamek R.J., Freitag Al., Labenz J, Rühl G.H., Aygen S., Hennemann 0., Wegener M.; Dtsch. med. Wschr. 119 (1994) 1569-157

9. Validity of a Novel Biopsy Urease Test and a Simplified ¹³C-Urea Breath Test for Diagnosis of Helicobacter pylori Infection and Estimation of Severoty of Gastritis
   Labenz J, Aygen S., Hennemann 0., Peitz U., Tillenburg B., Börsch G., Stolte M; Digestion; 1996; 57:391-397

10. Validity of a New Biopsy Urease Test and a Simplified ¹³C-Urea Breath Test for Diagnosis of Helicobacter pylori Infection and Estimation of Severotv of Gastritis
    Labenz J., Aygen S., Hennemann 0., Peitz U., Tillenburg B., Börsch G., Stolte M.; GUT 1; 37 (1995) 97

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Full Prescribing Information for Helicobacter Test INFAI ^®.
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