A comparison amongst three rapid urease tests to diagnose Helicobacter pylori infection in 375 consecutive dyspeptic

Abstract

Rapid diagnostic tools for Helicobacter pylori are important in endoscopy. To assess the accuracy of a new 5-min rapid urease test (UFT300, ABS Cernusco, sul Naviglio, Italy) compared with the 1-h Pyloritek (Serim Laboratories, Elkhart, IN) and the 24-h CLO test (Kimberly-Clark Ballard Medical Products, Roswell, GA), 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; Cernusco, sul Naviglio, Italy). Two additional rapid urease tests were performed. Patients were deemed infected when both 13C-UBT and histology were positive. Rapid urease tests were read at 1, 5, and 60 min, respectively. Of the 375 enrolled patients, 45.3% were infected with H. pylori. The sensitivity of the new 5-min rapid urease test 300 was 90.3, 94.5, and 96.2% at 1, 5, and 60 min, respectively (specificity 100%). The Pyloritek and the new 5-min rapid urease test were comparable, but the CLO test was not reliable at 5 and 60 min. In conclusion, the new 5-min rapid urease test is comparable to the Pyloritek test, but the CLO test is significantly less sensitive at early time points. Reading the test results at 1 min may increase false-negative results with decreasing sensitivity.