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Test Code UBT Helicobacter pylori Breath Test

Important Note

ASANTE order code: HPYBT

Epic/Beaker code is LAB572

Performing Laboratory

Mayo Medical Laboratories in Rochester

Reporting Name

H. pylori C Urea Breath Test

Specimen Type

Breath


Advisory Information


An alternative test for the diagnosis of active Helicobacter pylori infection in patients is the HPSA / Helicobacter pylori Antigen, Feces, which requires a different collection.



Necessary Information


For patients between 3 and 17 years old, complete the Pediatric UHR Calculation Information card: https://www.breathtekhcp.com/sites/default/files/pdf_hcp/pediatric-uhr-card.pdf



Specimen Required


Patient Preparation:

1. Fasting 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 <3 years old.

2. Follow instructions included with kit.


Reject Due To

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

NA

Specimen Stability Information

Specimen Type Temperature Time
Breath Ambient 7 days

Specimen Minimum Volume

Bag of ’’breath’’ must be full

Day(s) and Time(s) Performed

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

Specimen Retention Time

Discard immediately after testing

Analytic Time

Same day/1 day

Reference Values

Negative

Useful For

Diagnostic testing for Helicobacter pylori infection in patients suspected to have active H pylori infection or for monitoring response to therapy

Testing Algorithm

See Helicobacter pylori Diagnostic Algorithm in Special Instructions

Method Name

Infrared Spectrophotometry (SP)

Test Classification

This test has been cleared or approved 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 Information

The causal relationship between the urease-producing bacterium, Helicobacter pylori, and chronic active gastritis, duodenal ulcer, and nonulcer dyspepsia is well established. Conventional methods for the diagnosis of active H pylori infection include evaluation of biopsied gastric tissue by histopathology and culture. Less invasive assays include testing for the presence of H pylori antigen is stool specimens and detection of H pylori urease production by the Urea Breath Test (UBT). Serologic testing for the presence of IgM/IgG/IgA class antibodies to H pylori is also performed; however, this is not recommended by either the American College of Gastroenterologists nor the American Gastroenterological Association (AGA) as an accurate marker for active disease. These serologic markers can remain elevated despite resolution of active disease and may lead to misdiagnosis and/or inappropriate treatment.

 

Recommendations for use of the (13)C-Urea Breath Test (Meretek UBT) were recently provided by the Digestive Health Initiative, a joint committee assembled with representatives from the AGA, the American Society for Gastrointestinal Endoscopy (ASGE), and the American Association for the Study of Liver Diseases (AASLD).(1) These recommendations include the following statements: "When endoscopy is not clinically indicated, the primary diagnosis of H pylori infection can be made serologically or with the UBT. When endoscopy is clinically indicated, the primary diagnosis should be established by biopsy urease testing and/or histology. Available evidence suggests that confirmation of H pylori eradication is not mandatory in most situations because of costs associated with testing. However, for selected patients with complicated ulcer disease, low-grade gastric mucosa-associated lymphoid tissue lymphoma, and following resection of early gastric cancer, it is appropriate to confirm eradication. In other situations, the decision to confirm H pylori eradication should be made on a case-by-case basis."

 

This consensus group further specifies that there is no indication to test asymptomatic people and that testing for H pylori is only recommended if treatment is planned.

 

The (13)C-Urea Breath Test (Meretek UBT) is a highly sensitive and specific noninvasive, nonradioactive test for diagnosing H pylori infection prior to antimicrobial treatment and for assessing whether the organism has been successfully eradicated following antimicrobial therapy.

 

In 2 recent large prospective studies, the (13)C-UBT was shown to be as, or more, sensitive and specific for diagnosing H pylori active infection than culture, PCR, stain, rapid urease testing of biopsy tissue, or serology.

 

When the test is used to assess eradication, it should be performed 4 to 6 weeks after completion of antimicrobial treatment.

 

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 H heilmannii.

 

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

Cautions

This test is not appropriate for asymptomatic people.

 

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

 

For patients with phenylketonuria (PKU), the Pranactin-Citric solution contains phenylalanine (75 mg/dose; for reference, 12 ounces of a typical diet cola contains approximately 80 mg).

 

The patient should not have taken antibiotics, proton pump inhibitors (PPIs) or bismuth preparations for 2 weeks prior to the test. If PPIs are used within 2 weeks of BreathTek 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 Pranactin-Citric solution after thorough mixing, the solution should not be used.

 

The patient should have fasted for at least 1 hour before administering the breath test.

 

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.

 

The safety of using the BreathTek UBT kit during pregnancy and lactation is not established.

Clinical Reference

1. Talley NJ, Vakil NB, Moayyedi P: American gastroenterological association technical review on the evaluation of dyspepsia. Gastroenterology 2005;129:1756-1780

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 NH(4)(+) according to the following equation:

 

 

HPUrease

 

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

---------->

(13)CO2 + 2NH(4)+(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.(Graham DY, Malaty HM, Cole RA, et al: Simplified 13C-urea breath test for detection of Helicobacter pylori infection. Gastroenterology 2001;96:1741-1745)

Forms

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

Microbiology Test Request Form (T244) (http://www.mayomedicallaboratories.com/it-mmfiles/microbiology_test_request_form.pdf)

Gastroenterology and Hepatology Test Request Form (T728) (http://www.mayomedicallaboratories.com/it-mmfiles/gastroenterology-and-hepatology-test-request.pdf)