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

Intern Emerg Med. 2010 Feb;5(1):41-7. doi: 10.1007/s11739-009-0344-2.

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.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Aged
  • Breath Tests
  • Dyspepsia / microbiology*
  • False Negative Reactions
  • Female
  • Gastroscopy
  • Helicobacter Infections / diagnosis*
  • Helicobacter Infections / pathology
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Reagent Kits, Diagnostic*
  • Sensitivity and Specificity
  • Urea / analysis
  • Urease / analysis*

Substances

  • Reagent Kits, Diagnostic
  • Urea
  • Urease