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Helicobacter pylori Infection: Laboratory Support of Diagnosis and Management

Helicobacter pylori Infection: Laboratory Support of Diagnosis and Management

Clinical Focus

Helicobacter pylori Infection

Laboratory Support of Diagnosis and Management



Clinical Background

Individuals Suitable for Testing

Test Availability

Table: Characteristics of Nonendoscopic Tests for H pylori

Test Selection and Interpretation


Clinical Background [return to contents]

Helicobacter pylori infection is prevalent in North America (33%), especially among African Americans (52%), Hispanic Americans (64%), and immigrants from countries with widespread infection (eg, Korea [60%], Japan [39%]).1-3 It is typically acquired during childhood and, in adults and children, plays a causative role in diseases such as ulcers (eg, duodenal, gastric), uninvestigated dyspepsia, and gastritis (eg, chronic active, persistent, atrophic).1,2,4 Additionally, H pylori infection has been identified as an independent risk factor in 70% of gastric cancer and 90% of mucosa-associated lymphoid tissue (MALT) lymphoma cases.5,6

Helicobacter pylori infection usually responds well to a 3- to 14-day multidrug regimen, which may include first-line therapies such as clarithromycin-based triple therapy or bismuth-based quadruple therapy.1,*

Effective treatment depends on accurate diagnosis and post-treatment testing for the eradication of H pylori. Consideration may be given to current guidelines which recommend diagnostic and post-treatment testing using either a 13C-urea breath test (UBT) or stool antigen test.1,7,8

Individuals Suitable for Testing [return to contents]

Diagnostic Testing

  • Patients with symptomatic peptic ulcer disease, history of gastroduodenal ulcers, or MALT lymphoma
  • Patients with uninvestigated dyspepsia

Post-treatment Testing

  • Patients with a diagnosis of H pylori infection and ≥4 weeks post-treatment

Test Availability [return to contents]

Laboratory tests are available to help in the diagnostic workup of H pylori infection, and assess post-treatment eradication. They can be categorized as endoscopic or nonendoscopic.9 Rapid urease test (RUT) and histologic examination are assays available to help diagnose H pylori infection in upper gastrointestinal (GI) tract endoscopic biopsy specimens.7 UBT and stool antigen tests are nonendoscopic, noninvasive assays available as aids in the diagnosis and post-treatment monitoring of H pylori infection in adults and pediatric patients (Table).

Table. Characteristics of Nonendoscopic Tests for H pylori

  Urea Breath Test (UBT)10 Stool Antigen Detection11
Test name (test code)

≥18 years of age
Helicobacter pylori Urea Breath Test, InfraRed (UBiT®) (14839)

3-17 years of age
Helicobacter pylori, Urea Breath Test, Pediatric (92491)
All ages
Helicobacter pylori Antigen, EIA, Stool (34838)
CPT codea 83013 87338
Clinical utility

Help diagnose current infection

Assess treatment response

Help diagnose current infection

Assess treatment response

Document eradication


13CO2 release

H pylori antigen


Infrared spectrometry:

  • Patient ingests urea labeled with a nonradioactive carbon isotope (13C-urea); H pylori-associated urease degrades urea, producing ammonia and CO2; 13CO2/12CO2 ratio in baseline and post-ingestion samples measured
  • Results reported as positive or negative based on the difference between the pre- and post-13CO2/12CO2 ratios

Enzyme immunoassay:

  • Monoclonal antibodies used to detect H pylori antigens
  • Results reported as H pylori antigen detected, not detected, or indeterminateb
Primary reagent 13C-urea Mixture of monoclonal H pylori antibodies

Reference range

Not detected Not detected

Clinical sensitivityb, %

(95% CI)

For diagnosing

For assessing eradicationd



95 (93%–97%)c

97 (93%–99%)



96 (90%–99%)

95 (74%–99.9%)

Clinical specificityb, %

(95% CI)

For diagnosing

For assessing eradicationd



90 (73%–98%)c

95 (89%–98%)



96 (90%–99%)

96 (89%–99%)

Causes of false positives

Achlorhydria; other
urease-producing organisms
(eg, H heilmannii)

None known

Causes of false negatives

Proton pump inhibitorse


Bismuth-containing compoundse

Proton pump inhibitorse


Bismuth-containing compoundse

Very low antigen levels

FDA status

For in vitro diagnostic use

For in vitro diagnostic use

Sample type 1 bag of baseline breathg and 1 bag of post 13C-urea ingestioni breath 1 g frozen stool (0.5 g minimum) or 0.5 mL of liquid/semi-solid stool or 20-mm diameter solid stool

Sample stability





1 week





3 days

30 days


The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. A collection fee for breath samples will also be added when appropriate. Please direct any questions regarding coding to the payer being billed.


UBT sensitivity and specificity values are reported in adult patients.


Indeterminate results require testing with a new specimen.


Testing performed ≥4 weeks after end of therapy for H pylori eradication.


Ingestion of these medications ≤2 weeks before testing may cause a false negative result. If clinically indicated, the test may be repeated on a new specimen obtained 2 weeks after stopping treatment with these medications.6


The performance characteristics of this test have not been established for persons under 3 years of age.


The performance characteristics of this test have not been established for watery diarrheal stools or for asymptomatic individuals.


Patients should fast for at least 1 hour prior to baseline sample collection.


Patients with phenylketonuria should be told that the Pranactin®-Citric drink that will be administered contains phenylalanine, and that dietary intake of phenylalanine should be restricted.

Test Selection and Interpretation [return to contents]

Tests for Diagnosing

Test selection for diagnosing H pylori infection can depend on the patient's clinical condition and the physician's preferred strategy for diagnosis. Testing for H pylori should only be performed if the clinician plans to offer treatment for positive results as infection is rarely self-limiting.1

Patients With Symptomatic Peptic Ulcers, History of Gastroduodenal Ulcers, or MALT Lymphoma

Endoscopic biopsy or noninvasive tests such as UBT or the stool antigen test can help diagnose H pylori infection. Note that UBT has not been cleared by the FDA for use in individuals under 3 years of age.10 Examination of biopsy specimens by culture can be useful for determining infection status and antibiotic sensitivity. However, it is expensive and not widely available.12

Positive results on biopsy or from UBT or the stool antigen test indicate infection. Guidelines recommend that patients with positive results be offered H pylori eradication therapy.1,7 Negative results do not necessarily rule out infection and should be confirmed with additional testing, especially in the presence of acute upper GI bleeding.9

Patients With Uninvestigated Dyspepsia

Endoscopic biopsy and nonendoscopic tests, such as UBT and the stool antigen test, can also help diagnose H pylori infection in patients with uninvestigated dyspepsia. Patient age and the presence of alarm features can help guide the diagnostic workup of suspected H pylori infection.

Patients >55 Years of Age or With Alarm Features

Patients with uninvestigated dyspepsia who 1) are >55 years of age or 2) younger but have alarm features should be promptly tested with RUT or histologic examination of upper GI tract biopsy specimens.7 Alarm features include anemia, gastrointestinal bleeding, family history of gastrointestinal cancer, early satiety, unintended weight loss of >10%, history of esophagogastric malignancy, previous documented peptic ulcer, progressive dysphagia, odynophagia, persistent vomiting, palpable mass or lymphadenopathy, and jaundice.7,8 Positive results on biopsy indicate infection, and guidelines recommend offering H pylori eradication therapy to patients with positive results.1,7 Negative results should be confirmed with additional testing such as UBT or the stool antigen test; false negative results may be increased in the setting of acute GI bleeding.9

Patients ≤ 55 Years of Age Without Alarm Features

Although current guidelines differ somewhat, 2 main strategies are used to diagnose H pylori infection in patients with uninvestigated dyspepsia who are ≤ 55 years of age without alarm features.1,7,8

For the test first (test-and-treat) strategy, patients are first tested with a noninvasive assay for H pylori infection. Positive results from UBT or the stool antigen test indicate the need for treatment to eradicate H pylori, followed by a trial of acid suppression if symptoms persist after successful eradication. Negative results on noninvasive assays are followed by a 4- to 8-week empirical trial of acid suppression therapy with a proton pump inhibitor (PPI). This strategy may be most beneficial in populations with a moderate-to-high prevalence of H pylori infection, defined as >10% in some guidelines.1,8

For the treat first (empiric) strategy, patients are first treated with a 4- to 8-week empirical trial of acid-suppressing therapy with a PPI.1,7 If the PPI trial fails or the patient relapses after the end of treatment, the test-and-treat strategy should be pursued before contemplating endoscopy.1,7 Empirical treatment can be used in populations with a low prevalence of H pylori infection, defined as ≤10% in some guidelines.1,7

Post-treatment Testing

Treatment success should be assessed by follow-up testing with a noninvasive assay such as UBT test, stool antigen test, or upper GI tract endoscopic biopsy if endoscopy is indicated.1 UBT and antigen-based testing should be performed at least 4 weeks after treatment.1,12 This approach allows any remaining H pylori to recover and repopulate the stomach in sufficient numbers to be detected reliably.13 Detection of H pylori following eradication therapy indicates recurrence or ineffective treatment. Examination of endoscopic biopsy by culture may help assess H pylori antibiotic susceptibility in persistent infection but is limited by sample viability (ie, refrigeration up to 48 hours or frozen in broth at -70℃ up to 5 days).1

* The treating healthcare professional should refer to the manufacturer's approved labeling for prescribing, warnings, side effects and other important information relating to treatment options.

This information is provided for informational purposes only and is not intended as medical advice. A physician's test selection and interpretation, diagnosis, and patient management decisions should be based on his/her education, clinical expertise, and assessment of the patient.


References [return to contents]

  1. Chey WD, Leontiadis GI, Howden CW, et al. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2017;112:212-239.

  2. El-Serag HB, Kao JY, Kanwal F, et al. Houston Consensus Conference on Testing for Helicobacter pylori Infection in the United States. Clin Gastroenterol Hepatol. doi: 10.1016/j.cgh.2018.03.013.

  3. Grad YH, Lipsitch M, Aiello AE. Secular Trends in Helicobacter pylori Seroprevalence in Adults in the United States: Evidence for Sustained Race/Ethnic Disparities. Am J Epidemiol. 2012;175:54-59.

  4. Kim N. Synopsis of H. pylori-Associated Diseases. In: Kim N, ed. Helicobacter pylori. Singapore: Springer Singapore; 2016:175-185

  5. Asano N, Iijima K, Koike T, et al. Helicobacter pylori-negative gastric mucosa-associated lymphoid tissue lymphomas: A review. World J Gastroenterol. 2015;21:8014-8020.

  6. Armstrong H, Bording-Jorgensen M, Dijk S, et al. The Complex Interplay between Chronic Inflammation, the Microbiome, and Cancer: Understanding Disease Progression and What We Can Do to Prevent It. Cancers (Basel). 2018;10:83.

  7. Talley NJ. American Gastroenterological Association Medical Position Statement: Evaluation of Dyspepsia. Gastroenterology. 2005;129:1753-1755.

  8. Talley NJ, Vakil NB, Moayyedi P. American Gastroenterological Association Technical Review on the Evaluation of Dyspepsia. Gastroenterology. 2005;129:1756-1780.

  9. Chey WD, Wong BCY. American College of Gastroenterology Guideline on the Management of Helicobacter pylori Infection. Am J Gastroenterol. 2007;102:1808-1825.

  10. BreathTek UBT for H pylori [package insert]. Rockville, Maryland: Medical Device Division of Otsuka America Pharmaceutical Inc; January 2016.

  11. Premier Platinum HpSA Plus [package insert]. Cincinnati, Ohio: Meridian Biosciences Inc; 2014.

  12. Elfant AB, Howden CW, Stollman N. Contemporary Diagnostic Strategies for the Detection of Helicobacter pylori Infection. J Gastroenterol Hepatol. 2012;8:1-16.

  13. Attumi TA, Graham DY. Follow-up Testing After Treatment of Helicobacter Pylori Infections: Cautions, Caveats, and Recommendations. Clin Gastroenterol Hepatol. 2011;9:373-375.

Content reviewed 06/2018

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* The tests listed by specialist are a select group of tests offered. For a complete list of Quest Diagnostics tests, please refer to our Directory of Services.