Abstract

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 withno recent exposure to HP-altering drugs were enrolled. Gastric biopsy specimens were tested by the PUTand histology methods, and then the patients underwent [13C] urea breath tests (UBT). HP was consideredpositive when either UBT or histology demonstrated it, and negative if HP was not detected in eitherUBT or histology. The PUT was reported at 15 minutes. Results: 87 of 100 patients tested positive forHP. 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 clinicaldecision prior to patient discharge from the endoscopy suite. We recommend PUT for screening of HP inendoscopy candidates, due to high specificity, rapid reaction, simplicity and low cost. A positive resultshows a definite diagnosis, although a negative result needs further diagnostic methods.

Keywords: Evaluation Studies as Topic, Endoscopy, Cost-Benefit Analysis, Helicobacter Infections - pathology, Helicobacter pylori - isolation & purification, Hydrogen-Ion Concentration, Paper, Prospective Studies, Sensitivity and Specificity, Time Factors, Urea, Urease