title: 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.
  
  
  OBJECTIVE
  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).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.affiliation: Department of Internal Medicine and Gastroenterology, University of Bologna, Italy. berardino.vaira@unibo.it
authors.forename: D
authors.initials: D
authors.lastname: Vaira
authors.forename: N
authors.initials: N
authors.lastname: Vakil
authors.forename: L
authors.initials: L
authors.lastname: Gatta
authors.forename: C
authors.initials: C
authors.lastname: Ricci
authors.forename: F
authors.initials: F
authors.lastname: Perna
authors.forename: I
authors.initials: I
authors.lastname: Saracino
authors.forename: G
authors.initials: G
authors.lastname: Fiorini
authors.forename: J
authors.initials: J
authors.lastname: Holton
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000032:analysis; D004415:Dyspepsia / Q000150:complications*; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000175:diagnosis*; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D014510:Urease / Q000032:analysis*
chemical_list: D015415:Biomarkers; D011933:Reagent Kits, Diagnostic; D014510:Urease