Rapid Urease Test Developed to Diagnose H. pylori Infection in Asymptomatic Patients

A new rapid urease assay offers high sensitivity and accuracy for diagnosis of Helicobacter pylori in untreated patients.

Dyspepsia is a multifaceted range of symptoms related to the upper gastrointestinal (GI) tract. Population-based surveys have shown dyspepsia to be a global problem with 15% to 40% of the populace complaining of upper GI symptoms. Although several guidelines recommend an initial noninvasive “test and treat” approach for the diagnosis of H. pylori in primary care if patients do not complain of acute symptoms and are younger than 45-50 years, many dyspeptic patients are still referred for endoscopy.

In a recent cohort of US patients, about one-third of all upper endoscopic procedures were performed for patients with dyspeptic symptoms without alarm symptoms. In some countries, the high prevalence of gastric cancer in young dyspeptic patients also makes early endoscopy an important feature of dyspepsia management.

Endoscopic tests for H. pylori have progressed in the past 10 years and one area of growth has been the speed with which the rapid urease test (RUT) can be read. A new urease test, the Urea ultrafast-test--UFT 300, developed by ABS Advanced Biomedical Systems (Cernusco sul Naviglio, Italy) can be read in five minutes. The test, which was approved in the European Union, has the potential to simplify the clinical management further by allowing the result of the test to be included in the endoscopy report when patient leaves the endoscopy unit.

To assess the diagnostic accuracy of this new rapid urease test to diagnose H. pylori infection in untreated patients using an independent external reference standard, scientists from the department of internal medicine and gastroenterology at the University of Bologna (Italy) examined 1,000 consecutive dyspeptic patients and demonstrated that the new rapid urease UFT300 test offers high sensitivity (94.5%) and accuracy (100%), with a considerably shorter time period to read both a positive and a negative test.

The study was published January 2010 in the journal Alimentary Pharmacology & Therapeutics journal.

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ABS Advanced Biomedical Systems
University of Bologna