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Evidence summaries

Non-Invasive Diagnostic Tests for Helicobacter Pylori Infection

In people without a history of gastrectomy and those who have not recently had antibiotics or proton pump inhibitors, urea breath tests appear to have highest diagnostic accuracy while serology and stool antigen tests appear to be less accurate for diagnosis of Helicobacter pylori infection. Level of evidence: "B"

The quality of evidence is downgraded by indirectness (few direct comparisons).

Summary

A Cochrane review [Abstract] 1 included 101 studies with a total of 11003 subjects, of which 5839 participants (53.1%) had H pylori infection. Most of the studies (57%) included participants with dyspepsia and 53 studies excluded participants who recently had proton pump inhibitors or antibiotics. Thirty-four studies (4242 participants) evaluated serology; 29 studies (2988 participants) evaluated stool antigen test; 34 studies (3139 participants) evaluated urea breath test-13 C; 21 studies (1810 participants) evaluated urea breath test-14 C; and two studies (127 participants) evaluated urea breath test but did not report the isotope used.

Using data from 99 studies in an indirect test comparison, there was statistical evidence of a difference in diagnostic accuracy between urea breath test-13C, urea breath test-14C, serology and stool antigen test (P = 0.024).

Index testNumber of participants (studies)Diagnostic odds ratio (95% CI)Sensitivity (95% CI) at fixed specificity of 0.90Missed H pylori cases per 1000 people tested (95% CI)
Urea breath test 13 C3139 participants(34 studies)153 (95% CI 73.7 to 316)0.94 (0.89 to 0.97)30 (15 to 58)
Urea breath test 14 C1810 participants(21 studies)105 (95% CI 74.0 to 150)0.92 (0.89 to 0.94)42 (30 to 58)
Serology4242 participants(34 studies)47.4 (95% CI 25.5 to 88.1)0.84 (0.74 to 0.91)86 (50 to 140)
Stool antigen test2988 participants(29 studies)45.1 (95% CI 24.2 to 84.1)0.83 (0.73 to 0.90)89 (52 to 146)

Clinical comments

Note

Date of latest search:

    References

    • Best LM, Takwoingi Y, Siddique S et al. Non-invasive diagnostic tests for Helicobacter pylori infection. Cochrane Database Syst Rev 2018;(3):CD012080. [PubMed]

Primary/Secondary Keywords