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 (13)C-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 (13)C-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.
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 (13)C-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 (13)C-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.
Authors: Nansi López-Valverde; Bruno Macedo de Sousa; Antonio López-Valverde; Ana Suárez; Cinthia Rodríguez; Juan Manuel Aragoneses Journal: Front Med (Lausanne) Date: 2022-04-19