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HelpTest ID: UBT Helicobacter pylori Breath Test
Reporting Name
H. pylori C Urea Breath TestUseful For
Diagnostic testing for Helicobacter pylori infection in patients suspected to have active H pylori infection
Monitoring response to therapy
This test is not appropriate for asymptomatic people.
Testing Algorithm
For more information see Helicobacter pylori Diagnostic Algorithm.
Specimen Type
BreathOrdering Guidance
An alternative test for the diagnosis of active Helicobacter pylori infection in patients is the HPFRP / Helicobacter pylori with Clarithromycin Resistance Prediction, Molecular Detection, PCR, Feces, which requires a different collection.
Specimen Required
Patient Preparation:
1. Patient should be fasting for 1 hour.
2. Do not administer this test if this list of instructions is not followed, as test results may be inaccurate:
a. Do not administer this test if patient is allergic to citric acid.
Note: Product contains aspartame.
b. Patients should not take proton-pump inhibitors (eg, Prilosec, Prevacid, Aciphex, Protonix, and Nexium) or bismuth compounds (eg, Pepto-Bismol) for 2 weeks prior to testing.
c. Patients should not take antibiotics for 4 weeks prior to testing.
d. Histamine 2-receptor antagonists (H2RA), such as Pepcid, Tagamet, Axid, or Zantac may impact the sensitivity of the test and, if possible, should be discontinued for 2 weeks prior to testing.
3. 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 BreathID (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 Minimum Volume
Bag of ’’breath’’ must be full
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Breath | Ambient | 14 days | BREATH TEST BAG |
Special Instructions
Reference Values
Negative
Reference values apply to all ages.
Day(s) Performed
Monday through Friday, Sunday
Test Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
83013
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| UBT | H. pylori C Urea Breath Test | 29891-9 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 81590 | H. pylori C Urea Breath Test | 29891-9 |
Clinical Information
Helicobacter pylori is recognized as an important pathogen and a causal relationship between H pylori and chronic active gastritis, duodenal ulcer, and gastric ulcer is well documented. Currently there are numerous H pylori detection technologies for upper gastrointestinal disease including biopsy and serum analysis. These technologies depend on 2 general approaches for obtaining a sample for testing: invasive and noninvasive. The most common invasive test method requires an endoscopic gastric biopsy. The tissue collected from the biopsy is then examined in a laboratory by microbiologic culture of the organism, direct detection of urease activity in the tissue, by molecular testing, or by histological examination of stained tissue. Biopsy-based methods present an element of patient risk and discomfort and may provide false-negative results due to sampling errors.
The (13)C-urea breath test provides a noninvasive and nonhazardous analysis of the exhaled breath. The BreathID test measures the (12)CO2 (carbon dioxide) and (13)CO2 (labelled carbon dioxide) components of the exhaled breath before and after the oral ingestion of (13)C-enriched urea. This establishes the baseline ratio of (13)CO2/(12)CO2 and the post ingestion ratio of (13)CO2/(12)CO2 in order to determine the delta over baseline (change in the (13)CO2/(12)CO2 ratio).
The BreathID Hp Lab System, using molecular correlation spectroscopy (MCS), is intended for use to noninvasively measure changes in the (13)CO2/(12)CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active H pylori infection in the stomach. MCS uses infrared light to precisely match the CO2 molecule wavelength allowing for a smaller sample and minimal cross-sensitivity and low power consumption.
For more information see Helicobacter pylori Diagnostic Algorithm.
Interpretation
The Helicobacter pylori urea breath test can detect very low levels of H pylori and, by assessing the entire gastric mucosa, avoids the risk of sampling errors inherent in biopsy-based methods. In the absence of gastric H pylori, the (13)C-urea does not produce (13)CO2 (carbon dioxide) in the stomach.
A negative result does not rule out the possibility of H pylori infection. If clinical signs are suggestive of H pylori infection, retest with a new specimen or by using an alternative method.
A false-positive test may occur due to urease associated with other gastric spiral organisms observed in humans such as Helicobacter heilmannii.
A false-positive test could occur in patients who have achlorhydria.
Clinical Reference
1. Talley NJ, Vakil NB, Moayyedi P. American gastroenterological association technical review on the evaluation of dyspepsia. Gastroenterology. 2005;129(5):1756-1780
2. Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG Clinical Guideline: Treatment of Helicobacter pylori infection. Am J Gastroenterol. 2017;112(2):212-239. doi:10.1038/ajg.2016.563
3. Talley NJ, Ford AC. Functional dyspepsia. N Engl J Med. 2015;373(19):1853-1863. doi:10.1056/NEJMra1501505
Report Available
Same day/1 to 2 daysMethod Name
Qualitative Spectrophotometry
Forms
If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
-Infectious Disease Serology Test Request (T916)
-Gastroenterology and Hepatology Test Request (T728)
-Microbiology Test Request (T244)
-General Request (T239)
mml-gi-id, mml-gi-intestinal-infections, mml-gi-intestinal-infections-hpylori