Immunological rapid urease test using monoclonal antibody for Helicobacter pylori.

Background and Aim:  The current diagnostic methods for detecting Helicobacter pylori infection include rapid urease test (RUT), urea breath test (UBT), histology, culture, and serum antibody detection. The present study evaluated the efficacy of a novel highly specific test, an immunological RUT (IRUT), that uses a monoclonal antibody against H. pylori urease. Methods:  The clinical evaluation of the IRUT was performed in 100 subjects. Each gastric mucus sample obtained during endoscopic examination was incubated for 15 min with a solid tip coated with monoclonal antibody for H. pylori urease, and then the tip was introduced into a pH-monitoring cell containing urea solution. The change in pH of the solution after the enzymatic reaction (delta pH) was measured. The performance of the IRUT was compared with culture, histology, RUT, and UBT. Results:  Of the 47 H. pylori-positive subjects, 43 were IRUT positive (sensitivity, 91.5%), and of the 53 H. pylori-negative subjects, 52 were negative (specificity, 98.1%). Compared with the usual diagnostic methods, IRUT had high sensitivity and specificity for the detection of H. pylori and was no less efficient. Conclusions:  IRUT is a sensitive, specific and very rapid (within 20 min) method of detecting H. pylori infection.