Why BreathTek® UBT?

Pre- and Post-Treatment for Adult Patients

Test for H. pylori with BreathTek® UBT

BreathTek UBT for H. pylori Has Excellent Sensitivity (95.5%) and Specificity (96.0%) for Confirming Eradication1

Sensitivity and Specificity of Tests for
H. pylori Infection2,3

  Sensitivity Specificity
UBT 95%* 96%*
Stool
(antigen test)
93%* 93%*
Serology
(ELISA)
N/A N/A
Endoscopic biopsy
(Routine histology)
93% 90%
  • * Data are weighted mean values. Compilation of data is not the result of a comparative study.
  • ELISA = enzyme-linked immunosorbent assay.
  • Serology is not effective in post-treatment testing because it cannot distinguish between active and passive infection.
  • N/A = non-applicable.

False negative test results may be caused by

  • Ingestion of antimicrobials, proton pump inhibitors, and 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

Serology cannot distinguish between active and passive infection4

  • Serological tests are not appropriate to confirm eradication5-7
  • ACG and American Gastroenterological Association (AGA) guidelines recommend that serology not be utilized as a post-treatment confirmation of a cure5,6

Patient Preference Matters

Patients prefer UBT vs Fecal Antigen Test8

  • In a patient survey (n =140) comparing UBT and FAT vs serology, more patients preferred to be tested for H. pylori with a UBT vs a stool sample

The Urea Breath Test (UBT) method is recommended by the American College of Gastroenterology5

  • Appropriate choice for both initial diagnosis and post-treatment testing for active H. pylori infection

UBT method: Greater positive predictive value than serology9

UBT: Greater positive predictive value than serology

Effect of H. pylori prevalence on the positive predictive value of antibody testing (sensitivity=85% and specificity=79%) vs the urea breath test (sensitivity=95% and specificity=95%)

‡Data are not from a comparative study.

Urea Breath Test (UBT) method: most reliable nonendoscopic test to confirm eradication5

  • Accurately detects active gastrointestinal colonization by H. pylori
  • Preferred alternative when endoscopic follow-up is unnecessary
  • May avoid multiple gastric biopsies due to the variable prevalence and density of the infection throughout the stomach

Broad insurance plan coverage for patients

  • Covered by most major insurance providers
    • Check with insurance providers to confirm coverage

BreathTek UBT reimbursement codes

  • CPT code for test administration: 83014
  • CPT code for test analysis: 83013

This reimbursement information is being provided to help the healthcare professional understand and comply with billing and reimbursement requirements that may apply to products. Use of codes identified here does not guarantee coverage or payment at any specific level.

BreathTek UBT Makes Detection Convenient

The UBT method is more convenient compared with invasive H. pylori tests

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References:

  1. Package Insert for BreathTek UBT. Otsuka America Pharmaceutical, Inc; 2012.
  2. Vaira D, Vakil N. Blood, urine, stool, breath, money, and Helicobacter pylori. Gut. 2001;48(3):287-289.
  3. Maconi G, Vago L, Galletta G, et al. Is routine histological evaluation an accurate test for Helicobacter pylori infection? Aliment Pharmacol Ther. 1999;13(3):327-331.
  4. Vakil N, Fendrick AM. How to test for Helicobacter pylori in 2005. Cleve Clin J Med. 2005;72(suppl 2):S8-S13.
  5. Chey WD, Wong BCY; Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol. 2007;102(8):1808-1825.
  6. Talley NJ, Vakil NB, Moayyedi P. American Gastroenterological Association technical review on the evaluation of dyspepsia. Gastroenterology. 2005;129(5):1756-1780.
  7. Malfertheiner P, Mégraud F, O’Morain C, et al; European Helicobacter Pylori Study Group (EHPSG). Current concepts in the management of Helicobacter pylori infection—the Maastricht 2-2000 Consensus Report. Aliment Pharmacol Ther. 2002;16(2):167-180.
  8. McNulty CA, Whiting JW. Patients' attitudes to Helicobacter pylori breath and stool antigen tests compared to blood serology. J Infect. 2007;55(1):19-22.
  9. Chiba N, Veldhuyzen Van Zanten SJ. 13C-Urea breath tests are the noninvasive method of choice for Helicobacter pylori detection. Can J Gastroenterol. 1999;13(8):681-683.