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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

Testing With BreathTek UBT

BreathTek® UBT for H. pylori has excellent sensitivity (96%) and specificity (96%) when confirming eradication in adults*1

  BreathTek UBT in Adult Patients1
  Pre Post

Sensitivity

 95% 96%

Specificity

 90% 96%
  SAT (Stool Antigen Test)2
  Pre Post

Sensitivity

 93% 89%

Specificity

 93% 89%
  Serology (ELISA)2,3†
  Pre Post

Sensitivity

 85% NR

Specificity

 79% NR
  Endoscopic Biopsy (Routine Histology)4

Sensitivity

 93%

Specificity

 90%

Abbreviations: ELISA, enzyme-linked immunosorbent assay; SAT stool antigen test.

*Data are weighted mean values. Compilation of data is not the result of a comparative study.

†Serology is not effective in post-treatment testing because it cannot distinguish between active and past infection.

BreathTek® UBT for H. pylori aligns with guideline strategies to test, treat, and confirm eradication of active H. pylori infection3

ACG guidelines recommend UBT, FAT, and endoscopy for eradication testing.5

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—especially when the straw provided in the BreathTek UBT kit is not used.

BreathTek UBT is covered by Medicare, Medicaid, and most insurance providers6-10

Abbreviations: ACG, American College of Gastroenterology; FAT, fecal antigen test; UBT, urea breath test.

References