Evaluation of Exalenz Bioscience’s BreathID for Helicobacter pylori detection

Abstract

Carbon-labeled urea breath tests, which have high sensitivity and specificity, are the preferred method used in epidemiological studies, screening dyspeptic patients and assessing eradication or recurrence of Helicobacter pylori infection. The principle of the ¹³C-urea breath test relies upon the ability of the H. pylori urease to hydrolyze the orally administered ¹³C-urea. The BreathID^® (Exalenz Bioscience Inc., Union, NJ, USA) provides a competitive solution for breath testing, including unique features such as automatic continuous breath collection and analysis. This is an unattended convenient test, with no human error as the correct part of the breath is collected and patients’ assistance is not required. The test results are available in real time at the point of care and enable shortened breath testing procedures. Additionally, several studies showing expanded utility of the BreathID in pediatrics, after therapy and during proton pump inhibitors intake, further support the safety and performance of the BreathID in the diagnosis of H. pylori.

Keywords:

• BreathID^®
• gastric emptying
• Helicobacter pylori
• test substrate
• urea breath test

Financial & competing interests disclosure

H Shirin has received grants and stock options from Exalenz. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• The prevalence of Helicobacter pylori infection is decreasing in Western countries, but remains comparatively high in developing regions.

• The discovery of H. pylori led to a dramatic change in our understanding the pathogenesis of peptic ulcer and gastric malignant diseases.

• H. pylori is a major contributory factor in the development of human gastric cancer and has been classified as a group 1 carcinogen by WHO.

• Carbon-labeled urea breath tests, which have a high sensitivity and specificity, are the preferred non-invasive method used in epidemiological studies, screening dyspeptic patients and assessing eradication or recurrence of H. pylori infection.

• The use of urea breath tests, allowing identification of bacterial density and grading of the gastritis may potentially lead to more individualized effective therapies and increase the eradication rates.

• Technological advancements made over the past decade have not yet led to new diagnostic methods of clinically proven benefit in the diagnosis of H. pylori infection.

Notes