Cochrane for Clinicians

Putting Evidence into Practice

Noninvasive Diagnostic Tests for Helicobacter pylori Infection


Am Fam Physician. 2019 Jul 1;100(1):16-17.

Author disclosure: No relevant financial affiliations.

Clinical Question

Which noninvasive diagnostic test—urea breath test, serology, or stool antigen test—provides the most accurate diagnosis of Helicobacter pylori infection in symptomatic and asymptomatic patients?

Evidence-Based Answer

When compared with serology or stool antigen tests, the urea breath test has the highest diagnostic accuracy to identify H. pylori infection in patients without a history of gastrectomy or recent use of antibiotics or proton pump inhibitors. Use of any of these three methods in a hypothetical cohort with an H. pylori prevalence of 53.7% and fixed specificity of 90% resulted in 46 false-positive results out of 1,000 patients tested, and the urea breath test had the lowest false-negative rate.1 (Strength of Recommendation: B, based on inconsistent or limited-quality patient-oriented evidence.)

Practice Pointers

H. pylori infection affects 50% of the world's population.2 In the United States, the seroprevalence of H. pylori is higher in blacks (53%) and Mexicans (62%) than in whites (26%), and it is more common in groups with lower socioeconomic status.3 H. pylori infection can cause dyspepsia, peptic ulcer disease, and gastric cancers and is associated with iron deficiency anemia, idiopathic thrombocytopenia, and colorectal adenomas. Diagnostic tests used in the primary care office include serology and stool antigen tests, whereas the urea breath test and gastric biopsies require subspecialist referral. Once H. pylori has been detected, the treatment with standard therapy results in a 70% to 85% eradication rate.4

This review included 101 diagnostic studies involving a total of 11,003 patients, 5,839 (53%) of whom had confirmed H. pylori infection.1 The authors evaluated the diagnostic accuracy of the urea breath test-13C, urea breath test-14C, serology studies, and stool antigen tests. The reference standard was endoscopic biopsy with pathognomonic staining in the same patient. Studies included adults and children (1,508 children in 14 studies) with and without gastrointestinal symptoms, and most studies excluded patients with gastrectomy and recent (not defined) use of antibiotics or proton pump inhibitors. Eight of the studies (with 843 patients) were completed in North America; none of these studies included children. All but one study had a moderate to high risk of bias because of a lack of consecutive or random patient selection, lack of blinding, and variable test diagnostic thresholds.

The urea breath test had the highest diagnostic accuracy and lowest false-negative rate for the detection of H. pylori. To enable comparison of the tests in a hypothetical sample of 1,000 patients, the authors calculated false-negative rates at a prevalence of 53.7% and used a median specificity of 90%. At these fixed values, all four tests had a false-positive rate of 46 per 1,000, whereas the urea breath test had the lowest false-negative rate and the stool antigen test had the highest. The positive predictive values were similar.

The American College of Gastroenterology (ACG) recommends testing in patients with active peptic ulcer disease, dyspepsia symptoms, and gastric mucosa–associated lymphoid tissue lymphoma, whereas the Maastricht guidelines also include patients starting long-term nonsteroidal anti-inflammatory drugs, those with idiopathic

Author disclosure: No relevant financial affiliations.


show all references

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

2. Malfertheiner P, Chan FK, McColl KE. Peptic ulcer disease. Lancet. 2009;374(9699):1449–1461.

3. Everhart JE, Kruszon-Moran D, Perez-Perez GI, Tralka TS, McQuillan G. Seroprevalence and ethnic differences in Helicobacter pylori infection among adults in the United States. J Infect Dis. 2000;181(4):1359–1363.

4. Fashner J, Gitu A. Diagnosis and treatment of peptic ulcer disease and H. pylori infection. Am Fam Physician. 2015;15(91):236–242.

5. Malfertheiner P, Megraud F, O'Morain CA, et al. Management of Helicobacter pylori infection–the Maastricht V/Florence consensus report. Gut. 2017;66:6–30.

6. Chey WD, Wong BC. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol. 2007;102(8):1808–1825.

These are summaries of reviews from the Cochrane Library.

This series is coordinated by Corey D. Fogleman, MD, Assistant Medical Editor.

A collection of Cochrane for Clinicians published in AFP is available at



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