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Society Guidelines

06.10.2005

American Gastroenterological Association Medical Position Statement: Evaluation of Dyspepsia

This document presents the official recommendations of the American Gastroenterological Association (AGA) on Evaluation of Dyspepsia. It was approved by the Clinical Practice and Economics Committee on April 22, 2005, and by the AGA Governing Board on October 6, 2005.

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Disclaimer: The BreathID System is intended for use in the qualitative detection of H. pylori. It has an approved 510(K) and an approved NDA for the ¹³ C-urea Tablet and Citrica Powder.

Helicobacter pylori is a bacteria which may reside in the patient’s stomach, and may lead to peptic ulcer disease and stomach cancer. H. pylori infection is highly prevalent . Symptoms of H pylori include gastritis, dyspepsia , bloating, belching and more. The only way to know for sure if H. pylori is present is to be tested, as patients may be asymptomatic. H. pylori can be detected by a blood antibody test , a 13C-urea breath test and a stool test. The BreathID Breath Test System may be used as an aid in the detection of helicobacter pylori bacteria and in post treatment monitoring, through a ¹³C-urea breath test. The ¹³C-urea Breath Test is a simple, non-invasive testing option to detect H. pylori and with the BreathID Hp FasTest ^TM . The test has a sensitivity of 99.2% and a specificity of 100% in detecting active Helicobacter pylori infection.

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