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Helicobacter pylori Infection: Laboratory Support of Diagnosis and Management

This Clinical Focus provides information on Helicobacter pylori infection, focusing on the selection and interpretation of laboratory tests for diagnosis and assessing treatment response.

Clinical Focus

Helicobacter pylori Infection

Laboratory Support of Diagnosis and Management

Contents:

Clinical background

Individuals suitable for testing

Test availability

Table 1. Tests Available for Diagnosis and Management of H pylori Infection
Table 2. Characteristics of Nonendoscopic Tests for H pylori

Test selection and interpretation

References

Clinical background [return to contents]

Helicobacter pylori infection is a common bacterial infection that can cause chronic gastritis.^1,2 The prevalence of H pylori infection is approximately 25% in the United States and >40% worldwide.^3,4 Many people with H pylori infection are asymptomatic, but some develop serious gastrointestinal (GI) diseases including peptic ulcer disease, gastric cancer, and gastric mucosa–associated lymphoid tissue lymphoma (MALT).⁵ Infection is usually acquired during childhood and is more prevalent among patients of non-White races and ethnicities, immigrants from countries where H pylori is endemic, and individuals living in crowded or poor sanitary conditions.^1,4

Diagnosis and treatment of H pylori infection are important because infection is rarely self-limiting.⁵ A variety of diagnostic tests can detect infection, including a stool antigen test, urea breath test (UBT), rapid urease test, histology, culture, serology, and others. Serology was previously the most common approach, but it is no longer recommended because of its lower sensitivity and specificity for active infection.⁶

Treatment of H pylori infection typically involves a 10- to 14-day multidrug regimen, followed by testing for eradication at least 4 weeks after the end of treatment.⁴ Testing for eradication is important because H pylori eradication rates are declining⁴; most studies of current first-line therapies in the United States report eradication rates ≤80%.² After 2 failed therapies, antibiotic susceptibility testing is recommended by the American College of Gastroenterology (ACG) and the American Gastroenterological Association (AGA) to help guide subsequent eradication regimens.^4,7 The ACG also recommends susceptibility testing after taking into consideration past general antibiotic exposure and if there is a documented history of penicillin allergy.⁴

This Clinical Focus discusses how laboratory testing supports diagnosis and management of H pylori infection. The material is provided for informational purposes only and is not intended as medical advice. Test selection and interpretation, diagnosis, and patient management decisions should be based on the physician’s education, clinical expertise, and assessment of the patient.

Individuals suitable for testing [return to contents]

Diagnostic testing⁴

Patients with active or past peptic ulcer disease, marginal zone B-cell lymphoma (MALT lymphoma), unexplained iron deficiency anemia, idiopathic or autoimmune thrombocytopenic purpura
Adults in households with individuals who have a positive non-serological test for H pylori
Patients taking long-term non-steroidal anti-inflammatory drugs or starting long-term treatment with low-dose aspirin
Patients with functional dyspepsia or uninvestigated dyspepsia in patients <60 years of age or between 45 and 50 years if the patient is from a population at high risk for gastric cancer
Patients at high risk for primary gastric adenocarcinoma or gastric adenocarcinoma secondary to H pylori infection including patients with
Current or history of gastric premalignant conditions (atrophic gastritis, intestinal metaplasia, dysplasia), early gastric cancer resection, or gastric adenocarcinoma
Gastric adenomas or hyperplastic polyps
A first-degree relative with gastric cancer
Autoimmune gastritis

Post-treatment testing⁴

Patients at ≥4 weeks after completing eradication therapy for H pylori infection

Antibiotic susceptibility testing⁴

Patients who have had previous treatments for H pylori infection, past general antibiotic exposure, or other factors (eg, documented history of penicillin allergy) that make the choice of therapy unclear

Test availability [return to contents]

Laboratory tests for diagnosis and management of H pylori infection can be categorized as endoscopic or nonendoscopic.⁵ Endoscopic tests require GI tract biopsy specimens that are obtained during upper endoscopy, whereas nonendoscopic tests involve noninvasive specimen collection. Quest Diagnostics offers testing options for endoscopic and nonendoscopic specimens (Table 1). Additional information on available nonendoscopic tests is provided in Table 2.^8,9

Table 1. Tests Available for Diagnosis and Management of H pylori Infection [return to contents]

Test code	Assay	Method	Clinical use
Endoscopic biopsy specimens
16597	Helicobacter pylori Culturea,b	Culture	Isolate and identify organism
36994	Helicobacter pylori, Culture With Reflex to Susceptibilitya,b,c	Culture; antibiotic gradient diffusion	Isolate organism for identification and susceptibility testing to guide treatment selection
36995	Susceptibility, Antimicrobial, Helicobacter pylori, MIC^d	Antibiotic gradient diffusion	Guide treatment selection
Nonendoscopic specimens
34838	Helicobacter pylori Antigen, EIA, Stool	Enzyme immunoassay	Diagnose current infection; assess treatment response; document eradication
14839	Helicobacter pylori, Urea Breath Test	Infrared spectrophotometry

a	This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the US Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
b	Specimens should be collected in brucella or trypticase soy broth with 10%-20% glycerol; broth with 10%-20% glycerol should be transported frozen (-70 °C) and may be stored for up to 5 days; refrigeration using coldpacks are required for specimens without glycerol and sterile saline and may be stored for up to 48 hours. All other specimens are not acceptable.
c	Reflex tests are performed at an additional charge and are associated with an additional CPT code(s).
d	Specimens should be collected in brucella or trypticase soy broth with 10%-20% glycerol; broth with or without glycerol refrigerated at 2 °C-8 °C is acceptable but frozen at ≤-70 °C (dry ice) is preferred.

Table 2. Characteristics of Nonendoscopic Tests for H pylori [return to contents]

	Urea breath testing 8	Stool antigen detection9
	>3 years of age	All ages
Test name (test code)	Helicobacter pylori, Urea Breath Test (14839)	Helicobacter pylori Antigen, EIA, Stool (34838)
Measures	13CO2 release	H pylori antigen
Method	Infrared spectrophotometry 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 H pylori “detected” or “not detected” based on the difference between the pre- and post-13CO2 / 12CO2 ratios	Enzyme immunoassay Antibodies used to detect H pylori antigens Results reported as H pylori antigen "detected" or "not detected"
Reference range performance	Not detected	Not detected
Clinical sensitivity, % (95% CI)
Diagnosis	100 (90-100)	100 (89-99)^a
Assess eradication	Not reported	78 (45-94)^a
Clinical specificityb, % (95% CI)
Diagnosis	100 (97-100)	96 (89-99)^b
Assess eradication	Not reported	Not reported
Causes of false positives	Achlorhydria; other urease-producing organisms (eg, H heilmannii)	None known
Causes of false negatives	Proton pump inhibitorsb	Proton pump inhibitorsb
	Antimicrobialsb	Antimicrobialsb
	Bismuth-containing compoundsb	Bismuth-containing compoundsb
		Very low antigen levels
Specimen type	1 bag of baseline breathd and 1 bag of post–13C-urea ingestion breath	Minimum of 0.5 mL or 0.5 g of liquid/semi-solid stool or 20-mm diameter solid stool
Sample stability
Ambient	1 week	4 days
Refrigerated	Unacceptable	4 days
Frozen	Unacceptable	14 days

a	The performance characteristics of the stool antigen test have not been established for asymptomatic individuals. Colonic washes, barium enemas, laxatives, or bowel preparations can result in extensive dilution or the presence of additives that may affect test performance.
b	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.
c	Patients should fast for ≥1 hour prior to baseline sample collection.

Test selection and interpretation [return to contents]

Diagnostic testing

Tests performed on endoscopic biopsy specimens (eg, rapid urease test, histologic examination, or culture) and nonendoscopic tests (eg, UBT [test code 14839] or the stool antigen test [test code 34838]) can be used for the diagnosis of H pylori infection. Test selection depends on the clinical indication, test availability, and patient preferences.^5,10 Nonendoscopic tests are often preferred because they do not require invasive procedures.¹⁰ Tests that require endoscopic biopsy specimens are typically performed for more severe disease indications, such as active peptic ulcer disease or suspected gastric cancer.^5,10

For patients with uninvestigated dyspepsia, test selection also depends on age. Testing is recommended for patients <60 years of age, including the monitoring of those aged 45 to 50 years who are from high-risk populations for gastric cancer; monitoring can be done using a test-and-treat strategy⁴ in which patients are first tested with a nonendoscopic assay (usually a stool antigen test or UBT) followed by treatment to eradicate H pylori, if indicated.¹¹ For patients ≥60 years of age, endoscopy is recommended to rule out upper GI neoplasia.¹¹ Those with normal endoscopic findings and unknown H pylori infection status should have gastric biopsies obtained for H pylori testing (test code 16597).^11,12

For all types of H pylori tests, positive results indicate H pylori infection. Guidelines indicate that all patients with positive results be offered H pylori eradication therapy.⁴ Therefore, diagnostic testing for H pylori should only be performed if the clinician plans to offer treatment to patients who receive positive results.⁵

Post-treatment testing

Treatment success should be assessed by follow-up testing with a nonendoscopic test, such as UBT or a stool antigen test, or a biopsy-based test if an endoscopy is indicated.^4,5 Testing should be performed at least 4 weeks after completing eradication therapy.⁴ 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.

Antibiotic susceptibility testing

Assessment of H pylori antimicrobial susceptibility can assist treatment selection after persistent infection. After 2 failed treatments with confirmed patient adherence, the ACG and AGA advise consideration of H pylori susceptibility testing to guide selection of subsequent treatment regimens.⁴ Phenotypic susceptibility testing using agar dilution or antibiotic gradient diffusion requires culture of endoscopic biopsy specimens to isolate H pylori.¹ Culture-based susceptibility testing offered by Quest (test codes 36994 and 36995) assesses response to clarithromycin, amoxicillin, levofloxacin, metronidazole, and tetracycline.

References [return to contents]

Azad KN, Realegeno SE, Kagan RM, et al. An easily digestible review of Helicobacter pylori diagnostics. Clin Microbiol Newsl. 2022;44(6):51-61. doi:10.1016/j.clinmicnews.2022.03.001
Shah S, Hubscher E, Pelletier C, et al. Helicobacter pylori infection treatment in the United States: clinical consequences and costs of eradication treatment failure. Expert Rev Gastroenterol Hepatol. 2022;16(4):341-357. doi:10.1080/17474124.2022.2056015
Chen YC, Malfertheiner P, Yu HT, et al. Global prevalence of Helicobacter pylori infection and incidence of gastric cancer between 1980 and 2022. Gastroenterology. 2024;166(4):605-619. doi:10.1053/j.gastro.2023.12.022
Chey WD, Howden CW, Moss SF, et al. ACG clinical guideline: treatment of Helicobacter pylori infection. Am J Gastroenterol. 2024;119(9):1730-1753. doi:10.14309/ajg.0000000000002968
World Gastroenterology Organisation guidelines: Helicobacter pylori. Updated May 2021. Accessed October 7, 2025. https://www.worldgastroenterology.org/guidelines/helicobacter-pylori/helicobacter-pylori-english
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. 2018;16(7):992-1002.e6. doi:10.1016/j.cgh.2018.03.013
Shah SC, Iyer PG, Moss SF. AGA clinical practice update on the management of refractory Helicobacter pylori infection: expert review. Gastroenterology. 2021;160(5):1831-1841. doi:10.1053/j.gastro.2020.11.059
PyloPlus^® UBT Kit for PyloPlus^® UBT System. Package insert. Gulf Coast Scientific Inc; 2023. Accessed October 7, 2025. https://www.gulfcoastscientific.com/ifu
H. PYLORI CHEK^TM. Package insert. TECHLAB Inc; 2022. Accessed October 7, 2025. https://www.techlab.com/wp-content/uploads/2022/12/H-PYLORI-CHEK-PI-92-051-01-TL_12_2022-read.pdf
Lee YC, Dore MP, Graham DY. Diagnosis and treatment of Helicobacter pylori infection. Annu Rev Med. 2022;73(1):183-195. doi:10.1146/annurev-med-042220-020814
Moayyedi PM, Lacy BE, Andrews CN, et al. ACG and CAG clinical guideline: management of dyspepsia. Am J Gastroenterol. 2017;112(7):988-1013. doi:10.1038/ajg.2017.154
Yang YX, Brill J, Krishnan P, et al. American Gastroenterological Association Institute guideline on the role of upper gastrointestinal biopsy to evaluate dyspepsia in the adult patient in the absence of visible mucosal lesions. Gastroenterology. 2015;149(4):1082-1087. doi:10.1053/j.gastro.2015.07.039
Attumi TA, Graham DY. Follow-up testing after treatment of Helicobacter pylori infections: cautions, caveats, and recommendations. Clin Gastroenterol Hepatol. 2011;9(5):373-375. doi:10.1016/j.cgh.2010.12.025

Content reviewed 10/2025

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Related tests (5)

14839 - Helicobacter pylori, Urea Breath Test

Helicobacter pylori is a gram-negative microaerophilic curved bacillus with an affinity for human gastric mucosa. H. pylori has been identified as an important pathogen in the upper GI tract. The casual relationship between H. pylori and chronic active gastritis, duodenal ulcers, and gastric ulcers has been well documented. PyloPlus® UBT breath tests provide a non-invasive and non-hazardous method for detecting current H. pylori infection using urea breath analysis.

34838 - Helicobacter pylori Antigen, EIA, Stool

The importance of Helicobacter pylori in gastrointestinal diseases has increased greatly since Marshall and Warren described the presence of Campylobacter-like organisms in the antral mucosa of patients with histological evidence of antrum gastritis and peptic ulcers, especially duodenal ulcers. The strong correlation between the presence of H. pylori within histologically confirmed gastritis, peptic ulcer disease and gastric carcinoma and lymphoma, as well as disease resolution after H. pylori eradication, indicates a causative relationship. The ecological niche in humans appears to be restricted to the stomach and duodenum. Patients who harbor the organism are divided into two basic groups. The first are those who are said to be "colonized". These patients have the organism, yet have no signs of gastrointestinal disease. Those with gastrointestinal symptoms and a positive H. pylori antigen test are considered to be infected.

16597 - Helicobacter pylori Culture

Helicobacter pylori has been associated with peptic ulcer disease and cancers of the gastrointestinal tract.

36994 - Helicobacter pylori, Culture with Reflex to Susceptibility

Helicobacter pylori has been associated with peptic ulcer disease and cancers of the gastrointestinal tract.

36995 - Susceptibility, Antimicrobial, Helicobacter pylori, MIC

H.pylori susceptibility results can aid a physician in selecting antimicrobic therapy.

Related guides (0)

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Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

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