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Helicobacter pylori, Urea Breath Test

Test Codes: 14839

In February 2023, Quest Diagnostics transitioned the H pylori Urea Breath Test (UBT) to a new test platform. This conversion resulted in the implementation of a new Urea Breath Test collection kit, the PyloPlus UBT kit.

This FAQ addresses key questions and highlights important information about the new PyloPlus UBT collection kit.

The collection kit includes the following:

  • 1 pouch of 13C-urea powder
  • 1 packet of citric acid flavoring
  • 1 Quick Reference Instructions (QRI)
  • 2 breath collection bags: 1 blue bag for the BASELINE sample and 1 pink bag for the POST sample
  • 1 drinking straw
  • 1 sample transport bag
  • 1 Test instruction

The PyloPlus UBT collection bag uses a tamper-proof twist on-off cap (Illustration 1).

To open the PyloPlus UBT collection bag, the user twists the cap to the left (counterclockwise) until the tamper-proof plastic ring and the cap are detached from the mouthpiece–valve (Illustration 2a).

The tamper-proof plastic ring will remain attached to the cap (Illustration 2a). Removal of the tamper-proof plastic ring from the cap does not interfere with closing the bag. Removal is recommended.

To close the PyloPlus UBT collection bag, the user places the cap back on the mouthpiece–valve and twists the cap to the right (clockwise) until it has reached a stop (Illustration 2b).

To generate a properly inflated collection bag, the user should hold the uncapped collection bag by the stem of the mouthpiece–valve (Illustration 3a).

Then, the patient should inhale comfortably, hold breath for 10 seconds, exhale a small amount in the room, and then immediately put their mouth to the valve and exhale thoroughly into the bag (Illustration 3b). The patient must breathe out a small bit of air first so the bag will fill from their lungs and not their mouth. As soon as the user has exhaled fully, they should quickly put the cap onto the mouthpiece-valve and twist the cap clockwise until it has reached a stop. (Illustration 4).

Alternatively, the patient can follow the steps above and quickly hand the bag to the person overseeing the collection. The person overseeing the collection should hold the uncapped collection bag by the stem of the mouthpiece–valve, quickly put the cap onto the mouthpiece-valve and twist the cap clockwise until it has reached a stop. The bag should be closed right away. Holding the bag or pressing on the bag without closing the cap may cause the bag to deflate (Illustration 5). If by chance this happens, the patient can remove the cap by twisting left (counterclockwise) and recollect the sample.

The PyloPlus™ UBT collection bag uses a bidirectional (2-way) valve. The bidirectional valve allows for the breath sample to flow both into and out of the bag until the twist on-off cap is secured on the mouthpiece–valve. While some air will escape in the form of a “push back,” this is normal, and enough sample will remain trapped in the collection bag to perform an accurate test.

The benefit of the bidirectional valve is that it allows the patient to recollect the breath sample, if the initial sample was not collected correctly or according to procedure..

Incorrect sample collection procedure includes

  • The patient did not hold breath for 10 seconds before exhaling into the bag
  • The patient did not partially exhale in the room before fully exhaling into the bag.
  • The patient did not wait 15 minutes after ingesting the urea beverage and before collecting the test sample.
  • Breath volume in bag was inadequate after replacing cap.

Please note, the PyloPlus™ UBT collection bag requires sufficient inflation. While a partially full bag is not ideal, it is acceptable for testing. However, a flat collection bag is not acceptable for testing (Illustration 6).

If a breath sample needs to be recollected, simply flatten the collection bag to empty its content and proceed with recollecting the sample following the steps below. Instruct the patient to

  • Comfortably inhale.
  • Hold breath for 10 seconds.
  • Partially exhale in the room, then fully exhale into the bag.
  • Place twist on-off cap securely on the bag and twist it clockwise until it has reached a stop.

For questions about the Quest Diagnostics Helicobacter pylori, Urea Breath Test and specimen collections using the new PyloPlus™ UBT kit, please contact a Sales Representative.

For complete collection instructions, please visit: https://www.gulfcoastscientific.com/breath-test/

For a PyloPlus™ UBT sample collection demonstration video, please visit How to Administer the Pylo Plus UBT for H. pylori

This FAQ is provided for informational purposes only and is not intended as medical advice. A physician’s test selection and interpretation, diagnosis, and patient management decisions should be based on the physician’s education, clinical expertise, and assessment of the patient.

 

Document FAQS.302 Version: 1

Version 1 effective 06/10/2024 to present

Version 0 effective 08/21/2023 to 06/10/2024