The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy.
The BreathTek UBT Kit should be stored at 15°-30°C (59°-86°F). Pranactin-Citric has an expiration date of 48 months at 15°-30°C (59°-86°F). Do not use beyond the expiration date stated on the label.
1) Remind the patient that Pranactin-Citric contains phenylalanine (one of the protein components of Aspartame). Phenylketonurics restrict dietary phenylalanine.
2) The patient should have fasted at least 1 hour before administering the BreathTek UBT.
3) The patient should not have taken antimicrobials, proton pump inhibitors (PPIs), or bismuth preparations within 2 weeks prior to administering the BreathTek UBT. If PPIs are used within 2 weeks of BreathTek UBT testing, 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.
4) For administration by a healthcare professional only. Do not provide this kit to the patient for self-administration.
1) Verify that the patient has been prepared for the test as specified above
2) Label each breath collection bag to maintain patient identification according to your laboratory or office procedure.
3) Collect the BASELINE breath sample according to the following procedure:
a. Pick up the blue breath collection bag.
b. Remove the pull-off cap from the mouthpiece of the breath collection bag.
c. Instruct the patient to: (1) breathe normally; (2) take a deep breath then pause momentarily; (3) exhale into the mouthpiece of the bag.
d. Replace the cap firmly until it clicks on the mouthpiece of the bag.
4) Prepare the Pranactin-Citric solution no more than 60 minutes before administering it to the patient. Urea slowly decomposes in water.
a. Pick up the Pranactin-Citric pouch. Tap the upright packet of Pranactin-Citric to settle the contents in the bottom half.
b. 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.
c. Add drinking water to the fill line indicated on the outside of the cup by a raised plastic ridge.
d. 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.
5) 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.
6) Set the timer for 15 minutes. The patient should sit quietly and should not eat, drink or smoke during the 15 minute interval.
7) After 15 minutes have elapsed, pick up the pink breath collection bag. Collect the POST-DOSE breath sample according to the procedure described in Step 3.
8) Place the two collection bags in a large plastic baggie along with the Quest requisition. Store at room temperature until the Quest courier picks up.
BreathTek® UBT for H. pylori Kit package insert
Revision: April 2014 Print Code: 05US14L-0460A