באדיבות מדיקונטקסט: Last Updated: 2001-07-19 12:22:44 EDT (Reuters Health)
WESTPORT, CT (Reuters Health) – UBT-Lite is just as accurate as the US standard urea breath test (UBT) for diagnosing Helicobacter pylori infection, but it involves less-expensive ingredients, a shorter test duration, and a simplified breath test collection method.
Dr. David Y. Graham, from the Veterans Affairs Medical Center, in Houston, and colleagues compared the diagnostic ability of the US standard UBT with that of UBT-Lite in 249 volunteer subjects. All subjects underwent testing with both methods, including fasting and nonfasting assessments with UBT-Lite.
The US standard UBT formulation consisted of 125 mg of 13C-urea dissolved in 75 mL of water and a pudding test meal. Final breath sampling occurred 30 min after urea ingestion.
The UBT-Lite formulation consisted of 2.5 g of citrate, 150 mg of aspartame, and 75 mg of 13C-urea dissolved in 120 mL of water. Final breath samples were obtained 15 min after urea ingestion through direct exhalation into tubes.
Nearly all subjects had concordant results with the three breath tests, the authors report in the June issue of The American Journal of Gastroenterology. Ingesting solid or liquid food up to 1 hour before the UBT-Lite test had no bearing on the test results.
"Elimination of the solid test meal has the practical advantage of allowing a shorter test period as well as enhancing the convenience to the subject and the person administering the test," the authors point out. "This randomized trial showed that fasting for 4 hours before testing was unnecessary when citric acid was used instead of the pudding test meal," they add.
In addition, "this study showed that it was possible to reduce the amount of the expensive 13C-urea from 125 mg to 75 mg without loss in specificity or sensitivity," the researchers note.
UBT-Lite is produced by Meretek Diagnostics in Nashville, Tennessee, and it has been cleared by the Centers for Devices and Radiological Health and the US Food and Drug Administration for initial diagnosis and monitoring.
Am J Gastroenterol 2001;96:1741-1745.