Test ID: UBT
Helicobacter pylori Breath Test
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
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 Helicobacter pylori infection or for monitoring response to therapy
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
See Helicobacter pylori Diagnostic Algorithm in Special Instructions.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
Infrared Spectrophotometry (SP)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
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
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Container/Tube: Meretek UBT Breath Test Specimen Collection Kit (Supply T375)
Specimen Volume: Breath specimen
Collection Instructions:
1. Fasting (1 hour).
2. Do not collect if patient is <18 years old.
Additional Information:
1. 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.
2. If taking prescription levels of the H2-receptor antagonists (Pepcid, Tagamet, Axid, Zantac), it is suggested to move to the low-dose, over-the-counter strength for 2 weeks prior to testing and not taking the dose on the day of the test.
3. Carafate (sucralfate) does not interfere with the test.
4. An alternative test for the diagnosis of active Helicobacter pylori infection in patients younger than 18 years of age is the HPSA/81806 Helicobacter pylori Antigen, Feces which requires a different collection.
Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Breath | Ambient | 8 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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 Helicobacter pylori infection include evaluation of biopsied gastric tissue by histopathology and culture. Less invasive assays include testing for the presence of Helicobacter pylori antigen is stool specimens and detection of Helicobacter pylori urease production by the Urea Breath Test (UBT). Serologic testing for the presence of IgM/IgG/IgA class antibodies to Helicobacter 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 Helicobacter 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 Helicobacter 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 Helicobacter 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 Helicobacter 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 Helicobacter 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 Helicobacter 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.
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
Interpretation Provides information to assist in interpretation of the test results
The Helicobacter pylori urea breath test can detect very low levels of Helicobacter pylori and, by assessing the entire gastric mucosa, avoids the risk of sampling errors inherent in biopsy-based methods. In the absence of gastric Helicobacter pylori, the (13)C-urea does not produce (13)CO2 in the stomach.
A negative result does not rule out the possibility of Helicobacter pylori infection. If clinical signs are suggestive of Helicobacter 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
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).
Antimicrobials, proton pump inhibitors, and bismuth preparations are known to suppress Helicobacter pylori and ingestion of these within 2 weeks prior to performing the breath test may give false-negative results.
Premature collection time can lead to a false-negative diagnosis for a patient with 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 Helicobacter pylori as earlier posttreatment assessment may give false-negative results.
The performance characteristics of this test for persons <18 have not been established.
A correlation between the number of Helicobacter pylori organisms in the stomach and the breath test result has not been established.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
Talley NJ, Vakil NB, Moayyedi P: American gastroenterological association technical review on the evaluation of dyspepsia. Gastroenterology 2005;129:1756-1780
Method Description Describes how the test is performed and provides a method-specific reference
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 Helicobacter 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)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 6:30 a.m.-5 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
83013
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| 81590 | H. pylori C Urea Breath Test | 29891-9 |
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