A rapid, accurate, easy-to-use and low-cost DNA probe test kit for the detection of Campylobacter pylori, the microorganism associated with gastritis and peptic ulcer, will be developed for use in the endoscopy clinic and the pathology laboratory. Using whole genomic or short synthetic DNA probes in a non-isotopic format, this test will allow the rapid detection of C. pylori total nucleic acid or 16S ribosomal RNA, respectively, when present in endoscopic biopsies, stomach mucous, gastric juice or feces. The test will include a solid phase DNA probe and a solution phase labeled DNA probe. The target nucleic acid will be detected following formation of a hybridization complex consisting of the solid phase DNA probe, the target nucleic acid, and the solution phase labeled DNA probe. A final configuration of the prototype commercial DNA probe test kit product is proposed, as well as an evaluation of the test kit through a limited clinical trial.
