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

Abstract

Summary 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. Aliment Pharmacol Ther 31, 331–338

Prevalence of Helicobacter Pylori in Dyspeptic Patients and Outcome of Load Regimen on its Eradication

“…2010 the commercial rapid urease tests have sensitivity above 85%-95% and specificity above 95%-100% . (Vaira D, et al, 2010) That was parallel to the current study, urease test had sensitivity above 97.8% and specificity above 100%.…”

The Validity of the Invasive Tests for Helicobacter Pylori Diagnosis is Unequally Affected by the Consumption of Antibiotics or Pump Inhibitors. Test Performance under Real-World Conditions

“…In spite of the points made above, a limitation of our study might be that UFUT test might not be representative of all the remaining RUT tests, and there is scarce prior research about this issue. As shown below, Vaira et al [25] did not find differences reading test results in 5 or in 60 minutes. McNichols et al [24] reported higher frequency of positive tests in a prospective series in cases read at 60 minutes regarding those read at 5 minutes (90% vs 78%), but these results came from different populations and settings, which do not allow their comparison.…”

“…In patients not selected by PPI consumption, the UFUT with reading at 30 and 60 minutes have demonstrated to be at least as accurate as conventional RUT with reading up to 24 hours [24]. Previously, Vaira et al [25] did not find differences between UFUT with reading at 60 and 5 minutes in specificity (100% in both) and sensitivity [96.2 (95%CI: 94.5-98) vs. 94.5 (95%CI: 92.4-96.6)], in this case for patients without prior PPI.…”

Helicobacter pylori urease for diagnosis of Helicobacter pylori infection: A mini review

“…Studies of liquid-based RUTs and dry filter-paper test have suggested that some new platforms have shorter times to interpretability than agar tests such as the CLO test [51] . Some RUTs marketed in Europe have reported accurate results within minutes [52] , [53] . However, clinical experience has not shown rapid or ultrarapid results to be advantageous clinically especially when one considered the overall problem which includes diagnosis, treatment, follow-up, and associated issues (e.g., gastric cancer risk).…”