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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

  

Contents:

Clinical Background

Individuals Suitable for Testing

Test Availability

Test Selection and Interpretation - Table

References
 

Clinical Background [return to contents]

Helicobacter pylori infection has been associated with duodenal and gastric ulcers and chronic active, chronic persistent, and atrophic gastritis in adults and children. Infected persons have a 2- to 6-fold increased risk of developing gastric cancer and mucosal-associated-lymphoid-type (MALT) lymphoma.1,2 The majority of infected individuals respond to a multiple-drug regimen over a 2-week period.

Testing for H pylori can be used to diagnose infection but should only be performed if treatment is intended.3 Testing may also be used to document H pylori eradication after therapy.

Individuals Suitable for Testing [return to contents]

Testing is appropriate for individuals with uninvestigated dyspepsia, active peptic ulcer disease, a history of documented peptic ulcer, or MALT lymphoma.

Test Availability [return to contents]

Several methods can be used to diagnose H pylori infection: 1) upper gastrointestinal tract biopsy with histologic exam, rapid urease testing (RUT), or culture; 2) urea breath test (UBT) employing 14C- or 13C-urea; and 3) detection of H pylori antigen in stool. The UBT has not been FDA-cleared for use in individuals under 3 years of age.

Biopsy-based Assays

When endoscopy is indicated, RUT or histologic examination is useful to determine the presence of H pylori infection.3 Culture may be useful for antibiotic resistance testing in patients unresponsive to therapy, but it is not very sensitive and not widely available.4

Noninvasive Assays

The UBT and stool antigen test are highly sensitive and specific for H pylori infection (Table). These assays have been recommended by the American Gastroenterological Association (AGA) and the American College of Gastroenterologists (ACG) as the most accurate noninvasive tests for diagnosis of H pylori infection and for confirmation of eradication after therapy.3,5

Serology-based methods cannot distinguish between active and resolved infection.4,6 These tests are not recommended for initial diagnosis of H pylori infection6 or for confirming eradication.4,6 Thus, serology-based tests are not offered by Quest Diagnostics.

Table. Characteristics of Noninvasive Tests for H pylori

  Urea Breath Test (UBT)7 Stool Antigen Detection8
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)
Helicobacter pylori Antigen, EIA, Stool (34838)
CPT Codea 83013 87338
Clinical Utility
 

Diagnose current infection

Assess treatment response

Document eradication

Diagnose current infection

Assess treatment response

Document eradication

Measures

13CO2 release

H pylori antigen

Method Infrared spectrometry Enzyme immunoassay
Primary reagent 13C-urea Mixture of monoclonal anti-H pylori antibodies

Clinical Sensitivity, %

(95% CI)

For diagnosis

For eradicationb

 

 

95 (93–97%)

97 (93–99%)

 

 

96 (90–99%)

95 (74–99.9%)

Clinical Specificity, %

(95% CI)

For diagnosis

For eradicationb

 

 

90 (73–98%)

95 (89–98%)

 

 

96 (90–99%)

96 (89–99%)

False positives

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

None known
 

False negatives

Proton pump inhibitors

Antimicrobials

Bismuth-containing compounds

Very low antigenic levels

Proton pump inhibitorsc

Antimicrobialsc

Bismuth-containing compoundsc

FDA status

Clearedd

Cleared

Sample type Breath Stool

Sample stability

Ambient

Refrigerated

Frozen

1 week

Not applicable

Not applicable

Not applicablee

3 days

30 days

Sample handling

Room temperature

Frozen

CI, confidence interval.

a 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. Please direct any questions regarding coding to the payer being billed.
b Testing performed at least 4 weeks after end of therapy for H pylori eradication.
c Ingestion of these medications ≤2 weeks before testing may produce 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 Positive results are not affected by medication.
d The performance characteristics of this test have not been established for persons under 3 years of age.
e Quest Diagnostics does not accept room-temperature samples for this assay.

Test Selection and Interpretation  [return to contents]

Diagnosis

Patients with Active Peptic Ulcers, History of Peptic Ulcers, or MALT Lymphoma

H pylori infection may be diagnosed using endoscopy or noninvasive tests such as UBT or stool antigen. Factors that influence test selection include clinical condition, pretest probability of infection, and test availability and cost.4

Patients with Uninvestigated Dyspepsia

Patients with uninvestigated dyspepsia can be divided into 2 groups based on age and clinical features. Different strategies for H pylori diagnosis are recommended for each group.3,5,6

Patients >55 Years of Age or with Alarm Features

Prompt endoscopy of the upper gastrointestinal tract (esophagogastroduodenoscopy) is recommended for symptomatic patients >55 years of age and all patients with alarm features (eg, 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, or jaundice).3,5,6 Biopsy samples obtained during endoscopy may be used for diagnosis of H pylori infection, generally with RUT or histology. Positive results on biopsy indicate infection, and guidelines recommend that patients with positive results should be offered H pylori eradication therapy.5 Especially in the presence of acute upper gastrointestinal bleeding, negative results do not rule out infection and should be confirmed with additional testing.4

Patients ≤55 Years of Age without Alarm Features

Although current guidelines differ somewhat, 2 main approaches are used for diagnosis of H pylori infection in patients 55 years of age without alarm features3,5,6:

  1. Test and treat: First, test with a noninvasive assay for H pylori infection. Positive results with UBT or stool antigen 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.3,6

  2. Empirical treatment: A 4- to 8-week empirical trial of acid-reducing therapy with a PPI. 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.3 Empirical treatment can be used in populations with a low prevalence of H pylori infection, defined as 10% in some guidelines.3,6

Post-therapeutic Testing

Follow-up testing with a noninvasive assay (UBT or stool antigen), or an endoscopy-based assay if endoscopy is indicated, has been recommended to confirm eradication of H pylori infection after therapy.4 UBT and antigen-based testing should be performed no sooner than 4 weeks after therapy. If endoscopy is performed, culture may be useful to assess H pylori antibiotic susceptibility after failed eradication therapy.3

References [return to contents]

  1. Eslick GD, Lim LL, Byles JE, et al. Association of Helicobacter pylori infection with gastric carcinoma: a meta-analysis. Am J Gastroenterol. 1999;94:2372-2379.

  2. Parsonnet J, Hansen S, Rodriguez L, et al. Helicobacter pylori infection and gastric lymphoma. N Engl J Med. 1994;330:1267-1271.

  3. Talley NJ; American Gastroenterological Association. American Gastroenterological Association medical position statement: evaluation of dyspepsia. Gastroenterology. 2005;129:1753-1755.

  4. Chey WD, Wong BC; Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol. 2007;102:1808-1825.

  5. Talley NJ, Vakil N; Practice Parameters Committee of the American College of Gastroenterology. Guidelines for the management of dyspepsia. Am J Gastroenterol. 2005;100:2324-2337.

  6. Talley NJ, Vakil NB, Moayyedi P. American Gastroenterological Association technical review on the evaluation of dyspepsia. Gastroenterology. 2005;129:1756-1780.

  7. BreathTek® UBT for H pylori Kit [package insert]. Rockville, Maryland: Medical Device Division of Otsuka America Pharmaceutical Inc; 2014.

  8. Premier Platinum HpSA® Plus [package insert]. Cincinnati, Ohio: Meridian Bioscience Inc; 2012.
     

Content reviewed 09/2015

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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.