Test Catalog

Test Id : UBT

Helicobacter pylori Breath Test

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Helicobacter pylori Diagnostic Algorithm in Special Instructions

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Qualitative Spectrophotometry (SP)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

H. pylori C Urea Breath Test

Aliases
Lists additional common names for a test, as an aid in searching

H. Pylori Urea Breath Test

Helicobacter Pylori Breath Test

Pylori, Helicobactor Breath Test

Ulcer Breath Test

Urea Breath Test

UBT

(13)C Urea Breath Test

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Helicobacter pylori Diagnostic Algorithm in Special Instructions

Specimen Type
Describes the specimen type validated for testing

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.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

Bag of ''breath'' must be full

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

No specimen should be rejected.

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Helicobacter pylori Diagnostic Algorithm in Special Instructions

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Negative

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

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.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

In the Helicobacter pylori urea breath test, 75 mg (13)C-urea tablet and 4.3 g Citrica powder are dissolved in water, and the resulting solution is ingested by the patient. The presence of the Citrica creates an acidic environment in the stomach and delays the transfer of the ingested solution to the duodenum. These two characteristics facilitate the decomposition of the urea by H pylori, if present. Thus, in the presence of urease associated with gastric H pylori, (13)C-urea is decomposed to (13)CO2 and ammonia.

 

The (13)CO2 is absorbed into the blood and then exhaled in the breath. Absorption and distribution of (13)CO2 is fast. Therefore, the cleavage of urea by the H pylori urease that produces the (13)CO2 occurs immediately after the solution is ingested and enables immediate detection of increased (13)CO2 in the exhaled breath of H pylori-positive patients. In the case of H pylori-negative patients, the (13)C-urea does not produce (13)CO2 in the stomach because there are no human enzymes that can decompose the urea in the stomach.(Package insert: IDkit Hp Two for Exalenz BreathID Hp Lab System, Exalenz Bioscience Ltd; Revision 03, 03/2018)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday, Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 2 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Not retained

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

83013

LOINC® 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
Result LOINC Value Tooltip
81590 H. pylori C Urea Breath Test 29891-9

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports