Accuracy of a new ultrafast rapid urease test to diagnose Helicobacter pylori infection in 1000 consecutive dyspeptic patients

Abstract

Background Rapid diagnostic tools for Helicobacter pylori are important in endoscopy. Aims To assess the accuracy of a new 5 min rapid urease test (UFT300, ABS Srl, Cernusco sul Naviglio, Milan, Italy) and to compare it with the 1 h Pyloritek (Serim Laboratories, Elkhart, IN, USA) and the 24 h CLO test (Kimberly-Clark Ballard Medical Products, Roswell, GA, USA). Method Consecutive dyspeptic patients referred to our unit for endoscopy were prospectively studied. All patients underwent a 13C-urea-breath test, histology and the UFT300 (ABS Srl; Cernusco sul Naviglio, Milan, Italy). In a sub-set of patients (n = 375), two additional RUTs were performed. Patients were deemed infected if both 13C-UBT and histology were positive. RUTs were read at 1, 5, and 60 min. Results Of 1000 enrolled patients 45.3% were infected with H. pylori. The sensitivity of the UFT 300 was 90.3%, 94.5% and 96.2% at 1, 5 and 60 min respectively (specificity 100%). The Pyloritek and the UFT were comparable, but the CLO test was not reliable at 5 and 60 min. Conclusion The UFT 300 test is comparable to the Pyloritek test, but the CLO test is significantly less sensitive at early time points. Reading test results at 1 min may increase false negative results, thereby decreasing sensitivity.