Helicobacter Pylori Urea Breath Test, Infra-red (UBiT®)

Supply #155155 BreathTek Ubit Kit

Test code: 14839

CPT code(s): 83013

Methodology: Infra-red spectrophotometry (ir)

Reference range(s): Not detected

Clinical significance: Helicobacter pylori is a gram-negative microaerophilic curved bacillus with an affinity for human gastric mucosa. H. Pylori has been identified as an important pathogen in the upper gi tract. The casual relationship between h. Pylori and chronic active gastritis, duodenal ulcers, and gastric ulcers has been well documented. Breathtek™ UBiT® for h. Pylori is a non-invasive, non-radioactive method for detecting urease activity associated with h. Pylori infection. It is fda approved to confirm cure and offers 95.2% sensitivity and 89.7% specificity compared with endoscopic methods.

Alternative name(s): Breath Test, UBiT, Urea Breath Test, H. pylori

CLINICAL FOCUS: Helicobacter pylori Infection: Laboratory Support of Diagnosis and Management
This Clinical Focus provides information on Helicobacter pylori infection, focusing on the selection and interpretation of laboratory tests for diagnosis and assessing treatment response.

TEST HIGHLIGHT: Helicobacter pylori Antigen, EIA, Stool
Provides a brief overview of this test including clinical use and background, methodology, test interpretation, and specimen requirements.

Collection Guide: 

Supply: 155155 BreathTek UBT Kit

Preferred Specimen: Human breath: paired breath samples (pre and post) collected in breathtek(tm) ubt collection kit bags and must be submitted together. Follow instructions provided with kit.

The test can only be performed on specimens from patients greater than 3 years old.

For patients 3-17 years of age: gender, height, weight, and age, must be provided on the pediatric uhr card included in the BreathTek® UBT collection kit.

BreathTek® UBT for H. pylori delivers excellent sensitivity (96%) and specificity (99%) for diagnosing H. pylori in pediatric patients1

Patient preparation

  • The patient should have no food or drink for at least 1 hour before the test
  • The patient should not have taken antimicrobials, proton pump inhibitors (PPIs), or bismuth preparations for 2 weeks prior to the test. If PPIs are used within 2 weeks of administration of the BreathTek UBT, false negative test results may occur, and the test should be repeated 2 weeks after discontinuation of PPI treatment. A positive result for a patient on PPI could be considered positive and be acted upon
  • Remind the patient that Pranactin®-Citric contains phenylalanine (one of the protein components of Aspartame). Phenylketonurics restrict dietary phenylalanine*
  • For administration by a health care professional only. Do not provide this kit to the patient for self-administration.

*Phenylketonurics: Contains phenylalanine (one of the protein components of Aspartame), 84 mg per dosage unit. (For reference, 12 oz of typical diet cola soft drinks contain approximately 80 mg of phenylalanine.)

Verify that the patient has been prepared for the test.

Open the BreathTek UBT Kit, which should contain all the materials. Label each breath collection bag to maintain patient identification using the bar-code labels provided, or according to your laboratory or office procedure.

Step 1 Collect the BASELINE breath sample according to the following procedure:

  1. Pick up the blue breath collection bag.
  2. Remove the pull-off cap from the mouthpiece of the breath collection bag.
  3. Instruct the patient to:
    - breathe normally
    - take a deep breath then pause momentarily
    - exhale into the mouthpiece of the bag
  4. Replace the cap firmly until it clicks on the mouthpiece of the bag.

Step 2 For Solution Administration:

Prepare the Pranactin-Citric solution no more than 60 minutes before administering it to the patient. Urea slowly decomposes in water.
  1. Pick up the Pranactin-Citric pouch. Tap the upright packet of Pranactin-Citric to settle the contents in the bottom half.
  2. Tear off the top of the packet and carefully empty the contents into the drinking cup provided, making sure to transfer all of the contents by tapping on the bottom of the pouch.
  3. Add drinking water to the fill line indicated on the outside of the cup by a raised plastic ridge.
  4. Replace the lid securely and swirl the mixture for up to 2 minutes to dissolve the packet contents; typically, only 1 minute is required for complete dissolution. The resulting drug solution should be clear with no particulate matter. If particulate matter is present after thorough mixing, the drug solution should not be used.

Instruct the patient, including pediatric patients aged 3-17 regardless of age and body weight, to drink all of the drug solution with the straw provided, without stopping. Advise the patient NOT to ‘rinse’ the inside of his/her mouth with the drug solution before swallowing. Discard the straw after the patient has finished drinking the drug solution.

Step 3

Wait 15 minutes. The patient should sit quietly and should not eat, drink or smoke during the 15 minute interval.

Step 4

For PINK Post-Dose Collection Bag:

Collect the second breath sample in the pink bag using the same procedure as Step 1. Place cap on the bag and press down until it snaps to prevent sample loss.

Samples are good for 7 days, at room temperature, after collection.

Study design: A multicenter, open-label study. The primary endpoint analysis was conducted to determine the sensitivity and specificity of the BreathTek UBT UHR to the composite reference method criteria for the 176 evaluable cases. The table demonstrates the diagnostic performance of the BreathTek UBT (expressed as UHR) compared to the composite reference method criteria in pediatric patients ages 3 to 17 years.

Transport container: Tightly capped blue and pink bags. Bags may leak if cap is not attached. Keep each pair of breath samples together reusing the plastic kit pouch provided.

Transport Instructions: When shipping breath sample bags from pediatric patients to a laboratory for analysis, complete the pediatric UHR card by entering collection date, patient ID, gender, age, height and weight.

Place the completed card inside the sample transport bag along with the collected breath samples and the laboratory’s test requisition form.

Transport temperature: Room temperature

Specimen stability: Room temperature: 7 days

Reject criteria:
  • Reject specimen types other than Breathtek UBT bags.
  • Reject specimens from patients

Alternative name(s): Breath test

For additional supply or collection device information, please contact DLO's Customer Service at (800) 891-2917, option 2.

The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.