Prospective evaluation of a new urea-membrane test for the detection of Helicobacter pylori in gastric antral tissue

Aim: To determine the sensitivity, specificity, and positive and negative predictive values of a newly developed urea-membrane test for the detection of Helicobacter pylori in gastric tissue. Methods: Patients presenting for upper endoscopy with no recent exposure to H. pylori-altering drugs were enrolled. Antral biopsy specimens were tested by the urea-membrane and urea-gel methods and submitted for histology. Patients underwent [C-13]urea breath tests. Presence of H. pylori was established by histology or the combination of a positive [C-13]urea breath test and a positive urea-gel test. Absence of H. pylori required both the [C-13]urea breath test and the invasive tests to be negative. The urea-membrane test was reported at 1 hour. Results: Ninety-nine patients (47 men and 52 women) with a mean age of 51.43 +/- 14.9 years participated. Fifty of 99 patients (prevalence, 50.5%) tested positive for H. pylori. The urea-membrane test correctly identified 49 of 50 H. pylori-positive and 46 of 49 H. pylori-negative patients, yielding sensitivity, specificity, and positive and negative predictive values of 98.0%, 93.9%, and 94.2% and 97.9%, respectively, in this population. Conclusions: Rapidly available and reliable results from the urea-membrane test can facilitate clinical decision prior to patient discharge from the endoscopy suite.