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OAPI BreathTekTM Urea Breath Test (UBT for H. pylori)

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The BreathTeK UBT Collection Kit1 is used in adults to detect urease (an enzyme that breaks urea down into carbon dioxide and ammonia) associated with a bacteria (Helicobacter pylori) in the stomach and to help in the initial diagnosis and in the post-treatment monitoring of the bacteria infection (H. pylori). The test may be used for monitoring the treatment of the bacterial infection if it is used at least four (4) weeks after completing the treatment.

Some symptoms of an H. pylori infection include upset stomach, nausea, stomach pain, or burning or gnawing feeling in the stomach. Stomach pain may occur several hours after eating when the stomach is empty, may be worse at night, may last from a few minutes to several hours, or may be relieved by food, antacids or vomiting. You should talk to your healthcare provider about how this test can help in the treatment of your symptoms.

IMPORTANT SAFETY INFORMATION

BreathTek UBT is an in vitro diagnostic test requiring you to provide breath samples. 

§         You should not eat or drink for at least 1 hour before taking this test.

§         You should not take any antibiotics, proton pump inhibitors (acid blockers such as Zegerid®, Prilosec®, Prilosec OTC®, Prevacid®, Aciphex®, or Nexium®) or bismuth preparations (Pepto Bismol®) within 2 weeks prior to taking this test.

§         You must wait at least 4 weeks after completing the treatment to eliminate (eradicate) the H. pylori infection before taking this test again.

The drug component of the test is Pranactin®-Citric. It is taken by mouth as part of the diagnostic procedure. 

§         For Phenylketonurics (PKU) patients, this drug contains Phenylalanine (one of the protein components of Aspartame). For reference, 12 ounces of typical diet cola soft drinks contain approximately the same amount of Phenylalanine.

 Sometimes, false negative and false positive results can occur with this test. 

§         Tell your healthcare provider if you continue to have symptoms. You may need to be retested with a new sample or a different method.

The criteria for use of this test for persons under the age of eighteen (18) have not been established.

You should talk to your healthcare provider if you have questions about the safety of the BreathTek UBT Collection Kit.

1 Please see FULL PRESCRIBING INFORMATION for BreathTek.