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Test ID UBT Helicobacter pylori Breath Test

Reporting Name

H. pylori C Urea Breath Test

Useful 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

See Helicobacter pylori Diagnostic Algorithm in Special Instructions

Specimen Type

Breath


Ordering 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.



Necessary Information


 



Specimen Required


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 Minimum Volume

Bag of ’’breath’’ must be full

Specimen Stability Information

Specimen Type Temperature Time Special Container
Breath Ambient 14 days BREATH TEST BAG

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 two 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 tests provides a non-invasive and non-hazardous analysis of the exhaled breath. The BreathID test measures the (12)CO2 and (13)CO2 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.

 

See Helicobacter pylori Diagnostic Algorithm in Special Instructions.

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 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;129:1756-1780

2. Chey WD, Leontiadis GI, Howden CW, Moss SF: ACG Clinical Guideline: Treatment of Helicobacter pylori infection. Am J Gastroenterol. 2017 Feb;112(2):212-239. doi: 10.1038/ajg.2016.563

3. Talley NJ, Ford AC: Functional dyspepsia. N Engl J Med. 2015 Nov 5;373(19):1853-63. doi: 10.1056/NEJMra1501505

Report Available

Same day/1 to 2 days

Method Name

Qualitative Spectrophotometry (SP)

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Microbiology Test Request (T244)

-Gastroenterology and Hepatology Client Test Request (T728)

-General Request (T239)