What are the sensitivity and specificity of the urease (Urea Breakdown Enzyme) breath test for diagnosing Helicobacter pylori (H. pylori) infection?

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From the Guidelines

The urease breath test has a sensitivity of 88-95% and a specificity of 95-100% for detecting Helicobacter pylori infection. This test works by measuring carbon dioxide produced when H. pylori's urease enzyme breaks down urea labeled with either carbon-13 or carbon-14 1. The test is non-invasive, relatively quick, and can be used both for initial diagnosis and to confirm eradication after treatment.

Key Points to Consider

  • The test's high sensitivity and specificity make it one of the preferred non-invasive methods for H. pylori detection in clinical practice 1.
  • Patients should avoid antibiotics for 4 weeks before testing, proton pump inhibitors for 2 weeks, and bismuth preparations for 2 weeks, as these can cause false-negative results 1.
  • Patients should also fast for 4-6 hours before the test to ensure optimal accuracy.
  • False positives can occasionally occur with other urease-producing organisms in the oral cavity or stomach.

Test Characteristics

  • Sensitivity: 88-95%
  • Specificity: 95-100% The urease breath test is a reliable and efficient method for detecting H. pylori infection, with a high sensitivity and specificity, making it a valuable tool in clinical practice 1.

From the Research

Urease Breath Test Sensitivity and Specificity

  • The sensitivity and specificity of the urease breath test can vary depending on the study and the specific test used.
  • According to the study by 2, the sensitivity of the 13C-urea breath test was 97.4% (95% CI, 95-99%) and the specificity was 99.5% (98-100%) when using a cut-off point of -13.
  • Another study by 3 reported a sensitivity of 89% and a specificity of 73% for the urea breath test.
  • A systematic review by 4 found that the urea breath test had a high diagnostic accuracy, with a sensitivity of 0.94 (95% CI 0.89 to 0.97) and a specificity of 0.90 (median from studies across the four tests).

Factors Affecting Test Accuracy

  • The use of proton pump inhibitors (PPIs) can affect the accuracy of the urease breath test, with some studies suggesting that PPIs can cause false-negative results 5.
  • However, other studies have found that the stool antigen test, which is less likely to be affected by PPIs, can be a reliable alternative 6.
  • The choice of test and the specific protocol used can also impact the sensitivity and specificity of the urease breath test.

Comparison with Other Tests

  • The urease breath test has been compared to other diagnostic tests for Helicobacter pylori infection, including serology and stool antigen tests.
  • A study by 3 found that the stool antigen test had a higher sensitivity (96%) and specificity (83%) compared to the urea breath test (89% and 73%, respectively).
  • The systematic review by 4 found that the urea breath test had a higher diagnostic accuracy compared to serology and stool antigen tests.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Diagnostic values of Helicobacter pylori diagnostic tests: stool antigen test, urea breath test, rapid urease test, serology and histology.

Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences, 2011

Research

Non-invasive diagnostic tests for Helicobacter pylori infection.

The Cochrane database of systematic reviews, 2018

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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