Prospective evaluation of a new "paper urease test" for ultra-rapid detection of Helicobacter pylori.

BACKGROUND The purpose of this study was to determine the sensitivity, specificity, and positive and negative predictive values of a newly developed paper urease test (PUT) for ultra-rapid detection of helicobacter pylori (HP) in gastric mucosa. MATERIAL/METHODS 100 patients (43 men) with a mean age of 57+/-6.8 years participated. Patients presenting for upper endoscopy with no recent exposure to HP-altering drugs were enrolled. Gastric biopsy specimens were tested by the PUT and histology methods, and then the patients underwent [13C] urea breath tests (UBT). HP was considered positive when either UBT or histology demonstrated it, and negative if HP was not detected in either UBT or histology. The PUT was reported at 15 minutes. RESULTS 87 of 100 patients tested positive for HP. The PUT correctly identified 74 of 87 HP-positive and 13 of 13 HP-negative patients, yielding sensitivity, specificity, and positive and negative predictive values of 87%, 100%, 100% and 53.5%, respectively, in this population. CONCLUSIONS Rapidly available and reliable results from the PUT can facilitate clinical decision prior to patient discharge from the endoscopy suite. We recommend PUT for screening of HP in endoscopy candidates, due to high specificity, rapid reaction, simplicity and low cost. A positive result shows a definite diagnosis, although a negative result needs further diagnostic methods.