A PROSPECTIVE COMPARISON OF LOCALLY MADE RAPID UREASE TEST AND HISTOLOGY FOR THE DIAGNOSIS OF HELICOBACTER-PYLORI INFECTION

Background: A number of noncommercial preparations of urease test have been described. The present prospective study evaluated the accuracy of one such preparation for the diagnosis of Helicobacter pylori infec tion. Methods: From February 1996 to November 1996, all patients under going elective upper endoscopy in a single endoscopy facility were inc luded. Three antral biopsy specimens were taken. Two specimens were su bjected to histologic examination, and one specimen was placed into a ''locally made rapid urease test'' (LRUT). Results of histologic exami nations were taken as standards for comparison. The final result of LR UT was obtained on scrutiny of color changes at 4 hours after the star t of the test. Results: Two thousand three hundred sixteen patients (m ale/female = 1.5:1) with a mean age of 56.7 +/- 0.4 years were include d. Five hundred sixty-two patients (24.3%) had a history of eradicatio n treatment for H. pylori. Nine hundred fifty-three patients (41.1%) w ere found to be positive for H. pylori on histologic examination. In p atients in whom a history of eradication therapy was absent, the sensi tivity, specificity, and positive and negative predictive values of th e LRUT were 92.8%, 97.6%, 97.5%, and 93.0%, respectively. In patients with a history of eradication treatment, the corresponding figures wer e 76.1%, 99.6%, 96.2%, and 96.9%. Conclusions: The locally made rapid urease test provides a simple, safe, rapid, inexpensive, and accurate test for the diagnosis of H. pylori infection.