Accuracy of urea breath test in Helicobacter pylori infection: meta-analysis

World J Gastroenterol. 2015 Jan 28;21(4):1305-14. doi: 10.3748/wjg.v21.i4.1305.


Aim: To quantitatively summarize and appraise the available evidence of urea breath test (UBT) use to diagnose Helicobacter pylori (H. pylori) infection in patients with dyspepsia and provide pooled diagnostic accuracy measures.

Methods: We searched MEDLINE, EMBASE, Cochrane library and other databases for studies addressing the value of UBT in the diagnosis of H. pylori infection. We included cross-sectional studies that evaluated the diagnostic accuracy of UBT in adult patients with dyspeptic symptoms. Risk of bias was assessed using QUADAS (Quality Assessment of Diagnostic Accuracy Studies)-2 tool. Diagnostic accuracy measures were pooled using the random-effects model. Subgroup analysis was conducted by UBT type (13C vs 14C) and by measurement technique (Infrared spectrometry vs Isotope Ratio Mass Spectrometry).

Results: Out of 1380 studies identified, only 23 met the eligibility criteria. Fourteen studies (61%) evaluated 13C UBT and 9 studies (39%) evaluated 14C UBT. There was significant variation in the type of reference standard tests used across studies.Pooled sensitivity was 0.96 (95%CI: 0.95-0.97) andpooled specificity was 0.93 (95%CI: 0.91-0.94). Likelihood ratio for a positive test was 12 and for a negative test was 0.05 with an area under thecurve of 0.985. Meta-analyses were associated with a significant statistical heterogeneity that remained unexplained after subgroup analysis. The included studies had a moderate risk of bias.

Conclusion: UBT has high diagnostic accuracy for detecting H. pylori infection in patients with dyspepsia. The reliability of diagnostic meta-analytic estimates however is limited by significant heterogeneity.

Keywords: Breath tests; Diagnosis; Dyspepsia; Gastritis; Helicobacter pylori; Negative predictive value; Positive predictive value; Sensitivity; Specificity; Urea/analysis.

Publication types

  • Meta-Analysis
  • Review

MeSH terms

  • Biomarkers / metabolism
  • Breath Tests*
  • Chi-Square Distribution
  • Dyspepsia / diagnosis
  • Dyspepsia / microbiology
  • Helicobacter Infections / complications
  • Helicobacter Infections / diagnosis*
  • Helicobacter Infections / microbiology
  • Helicobacter pylori / metabolism*
  • Humans
  • Predictive Value of Tests
  • Reproducibility of Results
  • Urea / metabolism*


  • Biomarkers
  • Urea