Helicobacter pylori, Urea Breath Test (Adult and Pediatric)

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). 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. This type of valve is different than a unidirectional (1-way) valve.

• A unidirectional valve allows for the breath sample to go in only 1 direction (inside the bag).
• 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

• Patient did not hold breath for 10 seconds prior to exhaling into the bag
• Patient did not partially exhale in the room before fully exhaling in the bag
• Inadequate breath volume in bag 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

• 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.

Quest Diagnostics has developed and validated a Laboratory Developed Test (LDT) to collect and test pediatric specimens for H pylori using the new PyloPlus UBT collection kit.

• The analytical performance characteristics of the PyloPlus UBT in patients 3- to 17-years old have been determined by Quest Diagnostics.
• The modifications have not been cleared or approved by the FDA.
• This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
• The pediatric H pylori Urea Breath Test is validated for specimens from patients 3- to 17-years old and should be ordered using Test Code 92491 Helicobacter pylori, Urea Breath Test, Pediatric.

Test Code 92491 Helicobacter pylori Urea Breath Test, Pediatric is currently performed at 2 Quest Diagnostics locations: San Juan Capistrano, CA and Chantilly, VA.

For questions on the Quest Diagnostics Helicobacter pylori, Urea Breath Test and specimen collections using the new PyloPlus UBT kit, please contact your 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