Product

Helicobacter Test INFAI

13C-urea breath test for Helicobacter pylori infection

Helicobacter Test INFAI

Features

  • Internationally approved
    Helicobacter Test INFAI is approved in all countries of the European Union and can therefore be used in many other countries.
  • First approved for children
    Helicobacter Test INFAI is the first international approved Test for children of the age of 3-11 years.
  • Easy to use
    The simple and patient-friendly test protocol allows a high degree of reliability.
  • Non-invasive
    ¹³C-urea is naturally present in the human body so that no harmful side effects are to be expected. The test can be used during pregnancy and lactation.
  • No contraindications
    There are no known contraindications.
  • Extremely reliable control after eradication
    The test kit can be used before and after eradication therapy.
  • Sensitive and specific
    The effectiveness of the test in detecting active Helicobacter pylori makes it the new gold standard.
  • Cost-effective
    In many cases a breath test can indicate a Helicobacter pylori infection without having to resort to endoscopy.

Serialization 

Implementing the EU´s Falsified Medicines Directive - new line of INFAI packaging 

The EU´s Falsfied Medicines Directive (2011/62/EU) has been in force since 9 February 2019. The directive is expected toprotect the well-being of patients by putting an end to the criminal counterfeiting of medicine. The Falsfied Medicines Directive affects all medicinal products available on prescription.

To implement the directive, the outer packaging of every product shall be furnished with a certificate of authenticity. For the Helicobacter Test INFAI, this certificate of authenticity is guaranteed by the cellophane wrapping around the single test sampling tubes, and the safety seal on packaging intended for hospital use.

Furthermore, every packet will be furnished with an individual serial number. The serial numbers will be stored in the verification system database of the country in question. Before the product is given out to a patient, usually by a pharmacy, the serial number on the packaging is compared with the serial numbers stored in the database. If the serial number is stored there, the product is authentic, and will be given out to a patient. But if the serial number is not stored there, the product is a counterfeit. The pharmacy will bar these from being given out to patients. 

To implemented the Falsfied Medicines Directive, INFAI has furnished its line of packaging with the latest technology. That way, INFAI can apply all the required safety features, including individual serial numbers, in high quality, and to transmit all the necessary data to the databases of the national verification systems. Thanks to these measures, we can guarantee patients the highest possible level of protection against counterfeits of our products. 

Video Link: Falsfied medicines 

Videos

The following video gives an overview of the new modern production plant in Hagen as well as the performance of the 13C-urea breath test and analysis using different methods.

The following video shows the performance of the Helicobacter Test INFAI in a clinical study in Nottingham (Titel: Helicobacter eradication to prevent ulcer bleeding in aspirin users: a large simple randomised controlled trial. Sponsor: University of Nottingham, EudraCT Number: 2011-003425-96).

One of the most widely used ¹³C-Harnstofftest test worldwide

Helicobacter Test INFAI is a breath test for direct, non-invasive detection of the bacterium Helicobacter pylori. The test is a registered medical product and was approved by the European Commission in 1997 and included in the European Union Register of Medicinal Products. The test has subsequently been accepted in many countries outside the EU. Helicobacter Test INFAI is today a standard in diagnosis and one of the most widely used ¹³C-urea breath test worldwide. The test kit has been optimized for easy use by hospitals and physicians. Breath tests can be performed in a suitably equipped hospital laboratory or sent to a qualified laboratory.

You can find more information in the Helicobacter Test INFAI -Brochure.

Clinical indications for INFAI

Helicobacter Test INFAI detects a stomach infection by the bacterium Helicobacter pylori, which is considered the main cause of most types of stomach ulcers. The ¹³C-urea breath test is non-invasive and non-radioactive and is recommended by leading gastroenterological associations for use both before and after eradication treatment (European Society for Primary Care Gastroenterology; European Helicobacter pylori Study Group).

Klinische Indikationen für INFAI

Quality management and certification

ISO_9001_COL

In May 1999, INFAI GmbH successfully completed the audit for DIN EN ISO 9001 certification for the first time. The quality management system introduced covers all company areas including production, research and development, sales and service. The high quality standards defined within this system ensure the production of safe and high-quality pharmaceutical products. The satisfaction of our customers, and good relations with employees, sales partners and suppliers are the focus of our activities. 

Quality criteria of Helicobacter Test INFAI

The specificity (98.5%) and sensitivity (97.9%) of Helicobacter Test INFAI are similar to traditional invasive diagnostic methods (endoscopy and biopsy). As the breath test indicates the current status of Helicobacter pylori infection, it can be used to confirm successful eradication four weeks after the end of treatment.

Comparison of INFAI and Diabact 

Comparison of INFAI and Diabact Breathtest Diabact uses for the test performance a cut-off point of Δδ= 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 cut-off point can cause false negative results. This is because maximum urease activity takes between 20 and 30 minutes(also reported by V. Skar et al., Helicobacter 14 (4), 339, 2009). In the beginning, Diabact approved a dose of 2 x 50 mg 13C-urea. Later the dose was reduced to 50 mg. This low dose does not reach accuracy sufficient to be recommended in daily practice. In particular it can cause wrong results for patients with a high body weight. Especially after eradication therapy when H. pylori colonization rate is reduced, the overlapping between H. pylori positive and negative results is high, when Diabact test is performed. INFAI validated the cut-off point of Δδ= 4 ‰, a dose of 75 mg 13C-urea and a sampling time of 30 minutes by testing more than 9000 patients in several clinical trials inorder to achieve maximum sensibility and specifity. This corresponds with the values most used in the literature.(see also scientific discussion at EMA:

https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Scientific_Discussion/human/000140/WC500047589.pdf )

 

Another problem is the application of the 13C-urea tablets (by Diabact), which contain citric acid, as the tablet doesn’t dissolve completely within 5 minutes in the stomach fluid. The resulting real residence time in the antrum area and therefore contact to it is too short (10 minutes sampling time) and there’s also no considerable contact to the other stomach areas (fundus). It is known that H. pylori is not equally distributed over all areas in the stomach. Therefore the contact of the 13C-urea to all stomach areas is necessary in order to achieve correct results. This is not given by using the Diabact performance. In the INFAI test performance, the patient drinks a solution of 13C-urea in water, so there is no loss of efficiency because all stomach areas are in contact with the dissolved 13C-urea.

Studies on the Helicobacter Test INFAI

Study: 
Comparison of non-invasive tests to detect Helicobacter pylori infection in children and adolescents: results of a multicenter European study. Sponsor: INFAI

Study: PPI; Eudra CT Number: 2008-008010-39
The Sensitivity and Specificity in Helicobacter Pylori Positive and Negative Patients with Dyspepsia 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

Patents

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

clinipac50c

Due to increasing demand, INFAI now offers bulk packaging for clinical pharmacies and group practices.

  • Especially for general practitioners, laboratories and hospitals
  • Cost-effective, savings of 20-25% compared to individual tests
  • Contains test materials for the diagnosis of 50 patients
  • Safe and reliable

More information can be found in the Clinipac brochure.

Formulation of the Helicobacter Test INFAI

The following formulations of Helicobacter Test INFAI are available to the European Union and many other countries:

Name
Active Ingridient
Analytics EU-No.
HT INFAI 75 mg ¹³C-Urea IRMS EU/1/97/045/001
HT INFAI 75 mg ¹³C-Urea IRMS EU/1/97/045/002
HT INFAI for children
age 3-11
45 mg ¹³C-Urea IRMS EU/1/97/045/003
HT INFAI CLINIPAC 50 75 mg ¹³C-Urea IR-Spectroscopy  EU/1/97/045/004
HT INFAI CLINIPAC BASIC 75 mg ¹³C-Urea IRMS und IR Spectroscopy  EU/1/97/045/005

 

More information

More information about the Helicobacter Test INFAI can be found on the website of EUROPEAN MEDICINES AGENCY (EMA).

Patient Information
Product information: (Recent versions at EMA in various languages)

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)
  • Management of Helicobacter pylori infection
    The Maastricht V / Florence Consensus Report (Gut 2017; 66: 6-30)

INFAI Publications

  • 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
  • Tepeš B., Malfertheiner P., Labenz J., Aygen S. (2017)
    Modified Helicobacter test using a new test meal and a ¹³C-urea breath test in Helicobacter pylori positive and negative dyspepsia patients on proton pump inhibitors. World J Gastroenterol 23(32): 5954-5961.
  • 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.

The Helicobacter Test INFAI can be ordered from many distributors.