[Validation of a rapid urease test for the diagnosis of Helicobacter pylori infection]

Abstract

Objective: Several non-commercial rapid urease tests have been designed with the objective of reducing the cost of Helicobacter Pylori infection diagnosis. The objective of the present prospective trial is to assess one of these tests, using the histologic evaluation for the presence of Helicobacter Pylori, as the standard reference of diagnosing this infection.

Methods: Patients undergoing upper endoscopy for various reasons were prospectively enrolled. Three endoscopic biopsies of the antrum and three from the corpus of the stomach were taken in every patient enrolled. The specimens were evaluated by the rapid urease test on an individual basis, comparing the results with the histology assessment of the Helicobacter Pylori status, which was considered as the standard reference for the diagnosis of the infection.

Results: One hundred and four patients were enrolled, of which 94 were eligible. Fifty-five patients (60.43%) were infected with Helicobacter Pylori. The sensibility and specificity of the urease test evaluated at 4 hours was 65.45% and 100% respectively. The evaluation at 24 hours of the sensibility and specificity was 83% and 94% respectively.

Conclusions: The non-commercial rapid urease test is a practical, fast, and cost effective method for the detection of Helicobacter Pylori infection, and its diagnostic utility is similar to the commercial test available.