Helicobacter pylori Urea Breath Test (UBiT^®')

Clinical Use

•	Differential diagnosis of peptic ulcer disease and chronic active gastritis
•	Therapeutic monitoring and documentation of cure in patients with H pylori infection

Clinical Background
Helicobacter 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 (80% to 90% cure rate) 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 employing ¹⁴C- or ¹³C-urea. When endoscopy is indicated, histology is the test of choice.¹ Culture is not very sensitive and is recommended only for antibiotic resistance testing for patients unresponsive to therapy. Laboratory serology methods are more sensitive than those available in the physician's office, but none of the serology methods can distinguish between active and resolved infection; thus, they are not recommended for monitoring infection or confirming eradication of the organism. The stool antigen and urea breath tests have similar accuracy and are preferred when endoscopy is not clinically indicated.¹

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 Suited for Testing

Testing is not recommended for asymptomatic individuals lacking a history of peptic ulcer disease or for those on long-term proton pump inhibitor (PPI) therapy for gastroesophageal reflux disease (GERD). Moreover, testing should be performed only when treatment is intended.

Specimen Requirements
1 room-temperature bag containing a baseline breath sample and 1 room-temperature bag containing a post ¹³C-urea ingestion breath sample.

The patient should be off (for at least 2 weeks):

•	antibiotics
•	proton pump inhibitors
•	bismuth
•	and should fast for at least 1 hour prior to sample collection.

Patients can remain on H2 blocker therapy.

Additional instructions can be found in the BreathTek™' UBiT Collection Kit. When monitoring therapy, collect samples 4 or more weeks after the end of treatment.

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
•	Sensitivity, %*
	–	Diagnosis: 95 (95% CI, 93-97)
	–	Eradication: 96 (95% CI, 93-97)
•	Specificity
	–	Diagnosis: 95 (95% CI, 93-97)
	–	Eradication: 96 (95% CI, 93-97)
•	Aliases: H pylori UBiT
•	CPT Code†: 83013 (A breath sample collection fee will also be added when appropriate.)

Reference Range
Negative

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, proton pump inhibitors (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. For children under age 18, sex, age, and weight are required to interpret results.

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

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Online Test Information for Your Patients
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References

* These data reflect sensitivity and specificity data reported for the Gas isotope ratio mass spectrometry (GIRMS) method.2 Sensitivity and specificity data for the UBiT assay have not been reported. However, agreement between GIRMS and the UBiT method is approximately 99%.

† 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 payor being billed.

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