|
SAFETY INFORMATION
Intended Use:
The BreathTek™ UBT Collection Kit is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adult patients. The test may be used for monitoring treatment if used at least four (4) weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples.
For administration by health care professionals. To be administered under a physician’s supervision.
Warnings and Precautions:
1. For in vitro diagnostic use only. The Pranactin®-Citric drug solution is taken orally as part of the diagnostic procedure.
2. Phenylketonurics: Contains Phenylalanine (one of the protein components of Aspartame), 84 mg per dosage unit. (For reference, 12 ounces of typical diet cola soft drinks contain approximately 80 mg of Phenylalanine.)
3. A negative result does not rule out the possibility of Helicobacter pylori infection. False negative results do occur with this procedure. If clinical signs are suggestive of H. pylori infection, retest with a new sample or an alternative method.
4. Antimicrobials, proton pump inhibitors, and bismuth preparations are known to suppress H. pylori. Ingestion of these within two (2) weeks prior to performing the BreathTek™ UBT may give false negative results.
5. A false positive test may occur due to urease associated with other gastric spiral organisms observed in humans such as Helicobacter heilmannii.
6. Premature POST-DOSE breath collection time can lead to a false negative diagnosis for a patient with a marginally positive BreathTek™ UBT result.
7. A false positive test could occur in patients who have achlorhydria.
8. If particulate matter is visible in the reconstituted Pranactin®-Citric solution after thorough mixing, the solution should not be used.
Limitations:
1. The BreathTek™ UBT should not be used until four (4) weeks or more after the end of treatment for the eradication of H. pylori as earlier post-treatment assessment may give false negative results.
2. The performance characteristics for persons under the age of eighteen (18) have not been established for this test.
3. The specimen integrity of breath samples and reference gases stored in breath bags under ambient conditions has not been determined beyond seven (7) days.
4. A correlation between the number of H. pylori organisms in the stomach and the BreathTek™ UBT result has not been established.
5. The predicate device (Meretek UBT®) was standardized in asymptomatic healthy volunteers and subsequently validated in clinical trials limited to patients with documented duodenal ulcer disease.
Patient Preparation:
1. Remind the patient that Pranactin®-Citric contains phenylalanine (one of the protein components of Aspartame).
2. The patient should have fasted at least one (1) hour before administering the BreathTek™ UBT.
3. The patient should not have taken antimicrobials, proton pump inhibitors, or bismuth preparations within two (2) weeks prior to administering the BreathTek™ UBT.
|
|
|
