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Helicobacter pylori Urea Breath Test (UBiT)

Helicobacter pylori Urea Breath Test, Infra-red (UBiT)

Test Summary

Helicobacter pylori Urea Breath Test, Infra-red (UBiT®)

  

Clinical Use

  • Diagnose H pylori infection

  • Therapeutic monitoring and documentation of eradication in patients with H pylori infection

Clinical Background

H pylori is strongly associated with peptic ulcer disease (duodenal and gastric) and chronic active gastritis. H pylori infection is also an independent risk factor for gastric cancer and primary malignant lymphoma of the stomach. The infection can be treated successfully (70% to 90% eradication rates) with a combination of drugs for 10 to 14 days.1 

Four methods can be used to diagnose H pylori infection: 1) upper gastrointestinal tract biopsy, histologic exam, rapid urease testing (RUT), and culture; 2) antibody detection; 3) antigen detection; and 4) urea breath test (UBT) employing 14C- or 13C-urea. When endoscopy is indicated, RUT or histologic examination is useful to determine the presence of H pylori infection.2 Culture is not very sensitive but may be useful for antibiotic resistance testing in patients unresponsive to therapy.1,2 The urea breath test (UBT) and stool antigen test are recommended by both the American Gastroenterological Association (AGA) and the American College of Gastroenterology (ACG) as non-invasive tests for diagnosis and confirmation of eradication.1-3 Because of several drawbacks,1,3 serology tests are not recommended by the AGA for initial diagnosis of H pylori infection.3 Furthermore, they are not recommended by either the AGA or the ACG for confirming H pylori eradication.1-3

This urea breath test indirectly detects the presence of H pylori-associated urease by measuring CO2 in the patient’s breath. A baseline breath sample is collected before the patient ingests 13C-urea, ie, urea labeled with a naturally occurring, non-radioactive carbon isotope. A second sample is collected shortly after the ingestion. H pylori-associated urease degrades the urea, producing ammonia and CO2. The resultant CO2 is absorbed in the blood and then exhaled. An increase in the ratio of 13CO2 to 12CO2 between the pre- and post-ingestion samples indicates the presence of H pylori-associated urease.

Individuals Suitable for Testing1

Diagnostic Testing

  • Adults with symptomatic active peptic ulcer disease

  • Adults with a history of documented peptic ulcer

  • Adults with mucosal-associated-lymphoid-type (MALT) lymphoma

Testing should be performed only when treatment is intended.

Post-Therapeutic Testing

  • All adult patients

Method

  • Isotope-selective, nondispersive, infrared spectrometry urea breath test

   Ingestion of 13C-urea by patient (ie, urea labeled with a naturally occurring,
     non-radioactive carbon isotope)

   Degradation of urea by H pylori-associated urease, producing ammonia and CO2

   Measurement of 13CO2/12CO2 ratio in baseline and post-ingestion samples

   Results reported as positive or negative based on the magnitude of difference between

 the pre and post 13CO2/12CO2 ratios

  • Clinical Sensitivity, %a

    Diagnosis: 90 (95% CI, 73–98)

    Eradication: 95 (95% CI, 89–98)

  • Clinical Specificity, %a

    Diagnosis: 90 (95% CI, 73–98)

  • Aliases: H pylori UbiT; UBT

Interpretive Information

A negative result indicates the absence of H pylori-associated urease but does not rule out the possibility of H pylori infection. False-negative results may be due to antimicrobials, PPIs, and bismuth preparations ingested by the patient within 2 weeks prior to testing or due to collection of a test sample before the recommended interval following 13C-urea ingestion. When clinical signs warrant, a repeat test should be considered with this, or an alternative, test method.

A positive result is associated with the presence of H pylori infection, other gastric spiral organisms such as H heilmannii, and achlorhydria.

The performance characteristics of this assay for individuals <18 years of age have not been established. To test children 3 to 17 years of age, order test code 92491.

References

  1. Chey WD, Wong BCY; 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.

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

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

  4. 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.

  5. BreathTek™ UBT for H pylori [package insert]. Rockville, Maryland: Medical Device Division of Otsuka America Pharmaceutical Inc; 2010.
     

a These data reflect the clinical sensitivity and specificity data reported for the Meretek UBT® method, the previous version of this BreathTek™ UBT.5 Clinical sensitivity and specificity data for this BreathTek UBT assay have not been reported. However, agreement between the Meretek UBT and this BreathTek UBT is approximately 99%.5

Content reviewed 12/2012
 
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