Society Guidelines

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.