Helicobacter Test INFAI®
Helicobacter Test INFAI is a breath test for the direct, non-invasive detection of the bacterium Helicobacter pylori and is now a diagnostic standard and one of the most widely used ¹³C-urea breath tests worldwide. In 1997, INFAI received approval for the Helicobacter Test INFAI (HTI) first time in centralized procedure by EMA in all European countries and it is now available for routine diagnosis of Helicobacter pylori infection. In mean time HTI is registered in more than 40 countries outside the EU, and is covered by most health insurance companies. The test kit has been optimized for easy use by hospitals and doctors.
Features
- Internationally approved
Helicobacter Test INFAI was the first product to be approved by the EMA in 1997 as part of a central procedure in all countries of the European Union. Approval has been extended to 40 countries outside the EU. - Easy test performance
The simple and patient-friendly test protocol allows a high degree of reliability. It has a high sensitivity and specificity compared to other non-invasive tests. - No contraindications
There are no known contraindications. - High Sensitivity and Specificity
The test shows high sensitivity and specificity for the detecting of active Helicobacter pylori infection. This makes it the new gold standard in non-invasive testing. - Approved for children for the first time
Helicobacter Test INFAI has been approved for children aged 3-17 by the EMA for the first time throughout the EU. Until today, it is the only officially approved test for children aged 3-17 years. - Non-invasive
C-Urea is naturally present in the human body, so no harmful side effects are to be expected. The test can be used in children and during pregnancy and lactation. - Best reliable test to prove the eradication
The test kit can be used before and after eradication therapy. - Cost-effective
In many cases, a breath test can indicate Helicobacter pylori infection without resorting to a cost-intensive endoscopy investigation.