Prospective study to validate HpOne in the diagnosis of Helicobacter pylori infection.

INTRODUCTION The HpOne test is a new five-minute rapid urease test developed for the rapid detection of Helicobacter pylori infection during gastroscopy. However, evidence in the literature supporting its use clinically is scarce. The most commonly used rapid urease test remains the Campylobacter-like organism (CLO) test, which generates accurate readings only after 24 hours. The aim of this study was to evaluate the efficacy of the HpOne test in our local population. METHODS From August 2007 to May 2008, consecutive patients undergoing gastroscopy for various indications were recruited into this prospective study. Patients who were pregnant, lactating, on proton pump inhibitors, antibiotics, immunosuppressants or had previous gastric surgery were excluded. During gastroscopy, six gastric mucosal biopsies were taken; three from the body and three from the antrum. One body and one antral biopsy were used for each of the HpOne test, CLO test and histology. Results of the HpOne and CLO tests were then compared against the gold standard of histology. RESULTS Of the 149 patients recruited, 82 (55 percent) were men and 67 (45 percent) were women. The prevalence of Helicobacter pylori infection was 38.9 percent (n is 58). The sensitivity and specificity of the HpOne test were 65.5 percent and 85.7 percent, respectively, while those for the CLO test were 63.8 percent and 84.6 percent, respectively. CONCLUSION The HpOne test is as efficacious as the CLO test, with the added advantage of yielding results faster. It is thus a superior alternative and should be considered for clinical use.