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COVID-19 Update

Healthcare institutions and laboratories are encouraged to exercise and continue to practice appropriate clinical precautions when handling breath samples from patients. These groups should refer to their own policies on how to handle its COVID-19 response and should respond appropriately as the COVID-19 situation applies to and impacts its breath testing in its facilities.

Judgement on whether or not to test a patient using the BreathTek® UBT for H. pylori Kit should continue to be made by the patient’s prescribing physician and in collaboration with local testing laboratories on an individual patient basis.

While the COVID-19 situation continues to be dynamic, Otsuka sources the components of the BreathTek® UBT in the United States and currently does not foresee disruptions to its supply.

April 202005US20EBP0007

This site is intended for US Health Care Professionals Only

Using BreathTek UBT in Children

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

  3-5 Years 6-12 Years

Sensitivity

 Age
100% 100%

Specificity

 100% 100%
  13-17 Years Combined

Sensitivity

 Age All Pediatric Age Groups
92% 96%

Specificity

 98% 99%

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.

When using BreathTek UBT, false negative test results may be caused by:

  • Ingestion of proton pump inhibitors (PPIs) within 2 weeks prior to performing the BreathTek UBT. If a negative result is obtained from a patient ingesting a PPI within 2 weeks prior to the BreathTek UBT, it may be a false negative result and the test should be repeated 2 weeks after discontinuing the PPI treatment. A positive result for a patient on a PPI could be considered positive and be acted upon
  • Ingestion of antibiotics, or bismuth preparations within 2 weeks prior to performing the BreathTek UBT
  • Premature POST-DOSE breath collection time for a patient with a marginally positive BreathTek UBT result
  • Post-treatment assessment with the BreathTek UBT less than 4 weeks after completion of treatment for the eradication of H. pylori

False positive test results may be caused by urease associated with other gastric spiral organisms observed in humans, such as Helicobacter heilmannii or achlorhydria. Oral contamination associated with urease-containing bacteria may cause false positive results when not using the straw provided in the BreathTek UBT kit.

For pediatric test results. the UHR results must be calculated. DOB results and the web-based Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA) are required to determine pediatric patient test results.

  • The pUHR-CA is available at BreathtekKids.com
  • When accessing the calculator for the first time, you will need to create an account

For in-office sample collection and lab analysis:

  1. Administer the test in your office as you would with adult patients. Click here for Patient Preparation and Test Administration instructions
  2. Complete the pediatric UHR card with the following information—which is needed so that the lab can perform the analysis and UHR result using the web-based pUHR-CA
pediatric UHR card

Download the Pediatric UHR CardDownload the Pediatric UHR Card

Breath sample analysis must be performed within 7 days of breath sample collection.

Start using BreathTek UBT now.

For more information, contact OAPI customer service at 1.888.637.3835 or e-mail [email protected] so a representative can contact you.

References
  • Package Insert for BreathTek UBT. Otsuka America Pharmaceutical, Inc; 2019.