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Test Code 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.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Breath


Advisory Information


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


A completed Pediatric UHR Calculation Information card (see Special Instructions) is required for patients between 3 and 17 years old. Testing may be delayed if this information is not received with the specimen.



Specimen Required


Patient Preparation:

1. Patient should be fasting for 1 hour.

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

3. Histamine 2-receptor antagonists (H[2]RAs) 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.

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 (T375: fees apply)

Collection Instructions:

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

2. Follow instructions included with kit.


Specimen Minimum Volume

Bag of ’’breath’’ must be full

Testing Algorithm

See Helicobacter pylori Diagnostic Algorithm in Special Instructions

Specimen Stability Information

Specimen Type Temperature Time Special Container
Breath Ambient 7 days BREATH TEST BAG

Reference Values

Negative

Reference values apply to all ages.

Day(s) and Time(s) Performed

Monday through Friday, Sunday; 6:30 a.m.-5 p.m.

Test Classification

This test has been cleared, approved or is exempt by the U.S. 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 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

Method Description

In the Helicobacter pylori urea breath test, 3 g of reconstituted Pranactin-Citric solution containing 75 mg of (13)C-urea is ingested by the patient. In the presence of urease associated with gastric H pylori, (13)C-urea is decomposed to (13)CO2 and NH4(+) according to the following equation:

 

 

HPUrease

 

(NH2)(2) (13)CO + H2O + 2H

---------->

(13)CO2 + 2NH4+(13)C-urea

 

The (13)CO2 is absorbed in the blood, then exhaled in the breath. This results in an increase in the ratio of (13)CO2 to (12)CO2 in a TEST breath specimen compared to a BASELINE specimen taken before the Pranactin-Citric solution was consumed. Analysis of the breath specimen is performed by infrared spectrophotometry.(Package insert: BreathTek UBT for H.pylori Kit. Otsuka America Pharmaceutical, Inc; Revision 08/2019)

Analytic Time

Same day/1 day

Reject Due To

No specimen should be rejected.

Method Name

Infrared Spectrophotometry (SP)

Forms

1. For patients between 3 and 17 years old, the Pediatric UHR Calculation Information card is required, see Special Instructions.

2. 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)

Secondary ID

81590