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Immunological rapid urease test using monoclonal antibody for Helicobacter pylori
Author(s) -
NAKATA HIROYA,
ITOH HIDEKAZU,
ISHIGUCHI TADASHI,
IWATA TAKUYA,
SATO HIROAKI,
HIGASHIMOTO YUJI,
FUJIMOTO HISASHI,
ICHINOSE MASAO
Publication year - 2004
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/j.1440-1746.2004.03403.x
Subject(s) - helicobacter pylori , rapid urease test , urease , monoclonal antibody , medicine , spirillaceae , urea breath test , microbiology and biotechnology , antibody , histology , monoclonal , urea , gastroenterology , immunology , helicobacter pylori infection , biology , gastritis , biochemistry
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.