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25423 Helicobacter pylori Breath (UBT)

Helicobacter pylori Breath (UBT)
Test Code: UBTSO
Synonyms/Keywords
​13C Urea Breath Test, H. pylori Urea Breath Test, Ulcer Breath Test, Pylori, Helicobacter Breath Test, UBT, Urea Breath Test
Useful For

​Diagnostic testing for Helicobacter pylori infections in patients suspected to have active Helicobacter pylori infections or for monitoring response to therapy.

This test is not appropriate for asymptomatic people. 

Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
Yes - 1 hour​ ​Breath ​H. Pylori Breath Kit - Meridian Breath ID (T906: fees apply) ​Follow Kit Instructions
Collection Processing Instructions

*There will be an additional charge for the collection kit.*

Patient Preparation:

1. Patient should be fasting for 1 hour.

2. Patients should not have taken bismuth/Tritec, antimicrobials, proton-pump inhibitors (eg, Prilosec, Prevacid, Aciphex, Protonix, and Nexium) or bismuth preparations (eg, Pepto-Bismol) for 2 weeks prior to testing. If these instructions are not followed, test results may be inaccurate. Do not administer this test.

3. Histamine 2-receptor antagonists (H2RA) such as Pepcid, Tagamet, Axid, or Zantac should be discontinued for 24 to 48 hours before the BreathTek UBT test is administered. If these instructions are not followed, test results may be inaccurate. Do not administer this test.

4. Carafate (sucralfate) does not interfere with the test. Use of antacids does not affect the accuracy of this assay.

Supplies: H. Pylori Breath Kit - Meridian Breath ID (T906: fees apply)

Collection Instructions:

1. Do not collect if patient is younger than 3 years of age.

2. Follow instructions included with kit.

3. Mixing the (13)C-Urea Tablet

a. Dissolve the Citrica and the (13)C-enriched urea tablet in 150 to 200 mL (5.1 to 6.8 oz.) of tap water in the provided drinking cup.

b. Close the lid firmly using both hands. Place fingers over lid and shake thoroughly for a few minutes, until the Citrica Powder and the urea tablet are completely dissolved.

Note: Tiny particles may remain visible after thorough mixing. However, if more substantial particulate matter is still present after five minutes of mixing, discard the solution and repeat the procedure with a new kit.

Specimen Stability Information
Specimen Type Temperature Time
​Breath ​Ambient ​7 days
Rejection Criteria

​No specimen should be rejected.

Interference

Testing for Helicobacter pylori is only recommended if treatment is planned.

For patients with phenylketonuria (PKU), the Citrica powder/(13)C-urea solution contains phenylalanine (84 mg/dose; for reference, 12 ounces of a typical diet cola contains approximately 80 mg).

The patient should not have taken antimicrobials, proton pump inhibitors (PPI), or bismuth preparations for 2 weeks prior to the test. If PPI are used within 2 weeks of urea breath test (UBT) testing, false-negative test results may occur. Premature collection time can lead to a false-negative diagnosis for a patient with a marginally positive result.

If particulate matter is visible in the reconstituted Citrica powder/(13)C-urea solution after five minutes of thorough mixing, the solution should not be used.

The breath test should not be used until 4 weeks or more after the end of treatment for the eradication of H pylori as earlier posttreatment assessment may give false-negative results.

A correlation between the number of H pylori organisms in the stomach and the breath test result has not been established.

Data is insufficient for recommending the use of this test on patients with total or partial gastrectomy.

Data is insufficient to recommend the use of this test on pregnant and lactating women. 

Performing Laboratory Information
Performing Location Day(s) Test Performed Report Available Methodology/Instrumentation
​Mayo Clinic Laboratories ​Monday through Friday, Sunday ​1 to 2 days ​Qualitative Spectrophotometry (SP)
Reference Range Information

Negative

Reference values apply to all ages.

Interpretation

​The Helicobacter pylori urea breath test can detect very low levels of Helicobacter pylori and by assessing the entire gastric mucosa, avoids the risk of sampling errors inherent in biopsy-based methods.  In the absence of gastric Helicobacter pylori, the (13) C-urea does not produce (13)CO2 in the stomach.

A negative result does not rule out the possibility of Helicobacter pylori infection.  If clinical signs are suggestive of Helicobacter pylori infection, retest with a new specimen or by using an alternative method.

A false-postive test may occur due to urease associated with other gastric sprial organisms observed in humans such as Helicobacter heilmannii.

A false-positive test could occur in patients who have achlorhydria.

Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
83013​ ​1
Synonyms/Keywords
​13C Urea Breath Test, H. pylori Urea Breath Test, Ulcer Breath Test, Pylori, Helicobacter Breath Test, UBT, Urea Breath Test
Ordering Applications
Ordering Application Description
Clinical Order Manager​ ​Helicobacter pylori Breath
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
Yes - 1 hour​ ​Breath ​H. Pylori Breath Kit - Meridian Breath ID (T906: fees apply) ​Follow Kit Instructions
Collection Processing

*There will be an additional charge for the collection kit.*

Patient Preparation:

1. Patient should be fasting for 1 hour.

2. Patients should not have taken bismuth/Tritec, antimicrobials, proton-pump inhibitors (eg, Prilosec, Prevacid, Aciphex, Protonix, and Nexium) or bismuth preparations (eg, Pepto-Bismol) for 2 weeks prior to testing. If these instructions are not followed, test results may be inaccurate. Do not administer this test.

3. Histamine 2-receptor antagonists (H2RA) such as Pepcid, Tagamet, Axid, or Zantac should be discontinued for 24 to 48 hours before the BreathTek UBT test is administered. If these instructions are not followed, test results may be inaccurate. Do not administer this test.

4. Carafate (sucralfate) does not interfere with the test. Use of antacids does not affect the accuracy of this assay.

Supplies: H. Pylori Breath Kit - Meridian Breath ID (T906: fees apply)

Collection Instructions:

1. Do not collect if patient is younger than 3 years of age.

2. Follow instructions included with kit.

3. Mixing the (13)C-Urea Tablet

a. Dissolve the Citrica and the (13)C-enriched urea tablet in 150 to 200 mL (5.1 to 6.8 oz.) of tap water in the provided drinking cup.

b. Close the lid firmly using both hands. Place fingers over lid and shake thoroughly for a few minutes, until the Citrica Powder and the urea tablet are completely dissolved.

Note: Tiny particles may remain visible after thorough mixing. However, if more substantial particulate matter is still present after five minutes of mixing, discard the solution and repeat the procedure with a new kit.

Specimen Stability Information
Specimen Type Temperature Time
​Breath ​Ambient ​7 days
Rejection Criteria

​No specimen should be rejected.

Interference

Testing for Helicobacter pylori is only recommended if treatment is planned.

For patients with phenylketonuria (PKU), the Citrica powder/(13)C-urea solution contains phenylalanine (84 mg/dose; for reference, 12 ounces of a typical diet cola contains approximately 80 mg).

The patient should not have taken antimicrobials, proton pump inhibitors (PPI), or bismuth preparations for 2 weeks prior to the test. If PPI are used within 2 weeks of urea breath test (UBT) testing, false-negative test results may occur. Premature collection time can lead to a false-negative diagnosis for a patient with a marginally positive result.

If particulate matter is visible in the reconstituted Citrica powder/(13)C-urea solution after five minutes of thorough mixing, the solution should not be used.

The breath test should not be used until 4 weeks or more after the end of treatment for the eradication of H pylori as earlier posttreatment assessment may give false-negative results.

A correlation between the number of H pylori organisms in the stomach and the breath test result has not been established.

Data is insufficient for recommending the use of this test on patients with total or partial gastrectomy.

Data is insufficient to recommend the use of this test on pregnant and lactating women. 

Useful For

​Diagnostic testing for Helicobacter pylori infections in patients suspected to have active Helicobacter pylori infections or for monitoring response to therapy.

This test is not appropriate for asymptomatic people. 

Reference Range Information

Negative

Reference values apply to all ages.

Interpretation

​The Helicobacter pylori urea breath test can detect very low levels of Helicobacter pylori and by assessing the entire gastric mucosa, avoids the risk of sampling errors inherent in biopsy-based methods.  In the absence of gastric Helicobacter pylori, the (13) C-urea does not produce (13)CO2 in the stomach.

A negative result does not rule out the possibility of Helicobacter pylori infection.  If clinical signs are suggestive of Helicobacter pylori infection, retest with a new specimen or by using an alternative method.

A false-postive test may occur due to urease associated with other gastric sprial organisms observed in humans such as Helicobacter heilmannii.

A false-positive test could occur in patients who have achlorhydria.

For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Report Available Methodology/Instrumentation
​Mayo Clinic Laboratories ​Monday through Friday, Sunday ​1 to 2 days ​Qualitative Spectrophotometry (SP)
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
83013​ ​1
For most current information refer to the Marshfield Laboratory online reference manual.