Ordering Recommendation

Aids in the initial diagnosis and posttreatment monitoring of Helicobacter pylori infection in adult patients and in pediatric patients 3-17 years of age.

Posttreatment monitoring of H. pylori should be performed no sooner than 6 weeks after treatment for H. pylori infection. Earlier assessment may give false results.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation

Remind the patient that there is 84 mg of phenylalanine per packet of Citrica Powder. Phenylketonurics restrict dietary phenylalanine.
The patient should have fasted at least one hour before administering the solution. The patient should not have taken antimicrobials, proton pump inhibitors (e.g., Prilosec, Prevacid, Aciphex, Nexium), or bismuth preparations (e.g., Pepto Bismol) within two weeks prior to administering the test.

Collect

Breath Test Kit IDkit Hp Two (ARUP Supply #58132) available online through e-Supply using ARUP Connect™ or contact ARUP Client Services at 800-522-2787.

Specimen Preparation

1) Label breath collection bags with patient name, MRN, date and time of collection, and indicate Baseline (blue) or Post Ingestion (gray).
2) Collect the blue Baseline specimen according to the instructions in the Breath Test Kit, IDkit Hp (TM) Two. Instruct the patient to hold their breath for 4-5 seconds, and then exhale into the blue Baseline collection bag until the bag is full.
3) Prepare the test drink by adding 150 to 200 mL (5.1 to 6.8 oz.) water, the Citrica Powder, and the urea tablet to the provided drinking cup, closing the lid firmly, and shaking thoroughly until the powder and tablet are completely dissolved.
4) Administer the test drink within two hours of preparation per kit instructions and precautions. Regardless of age and body weight, the patient must consume the entire solution through the provided straw within 2 minutes.
5) Collect the gray Post Ingestion specimen 15 minutes after ingestion of the test drink, but no later than 20 minutes post ingestion. Instruct the patient to hold their breath for 4-5 seconds, and then exhale into the gray Post Ingestion collection bag until the bag is full.
6) Ensure the caps on the bag mouthpieces are secured (push until they click).

Storage/Transport Temperature

CRITICAL ROOM TEMPERATURE. Do not freeze. Protect bags from sharp objects and direct sunlight. Refrain from applying any external pressure on the breath sample bags.

Unacceptable Conditions

Underinflated or uncapped bags. Specimens from patients younger than 3 years. Specimens collected using the BreathTek UBT Kit (blue and pink collection bags).

Remarks
Stability

Ambient: 2 weeks; Refrigerated: Unacceptable; Frozen: Unacceptable.

Methodology

Qualitative Spectrophotometry

Performed

Sun-Sat

Reported

1-4 days

Reference Interval

Negative

Interpretive Data

A negative result does not rule out the possibility of Helicobacter pylori infection. If clinical signs are suggestive of H. pylori infection, retest with a new specimen or an alternate method.

Known causes of false-negative results include:

1. Ingestion of antimicrobials, proton pump inhibitors, and bismuth preparations during the preceding 2 weeks.

2. Administration of the breath test less than 6 weeks after completion of definitive therapy to eradicate H. pylori.

3. Premature or late collection of the postdose specimen.

Known causes of false-positive results include:

1. Patients with achlorhydria.

2. Rinsing the testing solution in the mouth or not using the straw provided in the kit, which can allow contact with urease-positive bacteria.

3. The presence of other gastric spiral organisms such as Helicobacter heilmannii.

Compliance Category

FDA

Note

Hotline History

N/A

CPT Codes

83013

Components

Component Test Code* Component Chart Name LOINC
3006272 H. pylori, Breath Test 29891-9
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • 13C Urea Breath Test
  • BreathID
  • H pylori
  • H. pylori Urea Breath Test
  • Helicobactor
  • Helicobactor pylori Breath Test
  • Pylori
  • UBIT
  • UBT
  • Ulcer Breath Test
  • Urea Breath Test
Helicobacter pylori, Breath Test